Straumann SLActive labeling changes

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Institut Straumann AG % Jennifer Jackson Sr. Director, Regulatory Affairs and Ouality Straumann USA. LLC 60 Minuteman Rd Andover, Massachusetts 01810 Re: K223083 Trade/Device Name: Straumann® SLActive® labeling changes Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: Class II Product Code: DZE Dated: May 26, 2023 Received: May 26, 2023 Dear Jennifer Jackson: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. # Andrew I. Steen -S Andrew I. Steen Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K223083 #### Device Name Straumann® SLActive® labeling changes Indications for Use (Describe) #### Straumann® BLX Dental Implants, SLActive® Strauman® dental implants are indicated for functional and esthetic of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation or loss of natural teeth. The implants can be placed with immediate function for single-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. #### Straumann® TLX Dental Implants, SLActive® Strauman® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth restorations when qood primary stability is achieved and with appropriate occlusal loading to restore chewing function. #### Other Straumann® Tissue Level and Bone Level Dental Implants, SLActive® Straumann® dental implants are indicated for functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. Unless stated in specific indications, they can be used for immediate, early or late implantation or loss of natural teeth. The implants can be placed with immediate function for multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. Specific indications for use: #### Straumann® Roxolid® Bone Level Tapered Implant Ø 2.9 mm The Strauman® Roxolid® Bone Level Tapered implants ø 2.9 mm are indicated for single-unit reconstruction of incisors in the lower jaw and lateral incisors in the upper jaw. #### Straumann® Roxolid® Standard Plus 4 mm Short Implants Straumann® Roxolid® Standard Plus 4 mm Short Inplants are indicated for fixed or removable reconstruction in situations of moderate to severely atrophic jawbone with adequate bone primary stability after implant insertion, where a longer implant cannot be placed due to limited vertical bone height. The recommended healing is between 10 to 12 weeks. Straumann® Roxolid® Standard Plus 4 mm Short Implants are specifically indicated for: - . Fixed denture prosthesis/splinted units (one implant per unit). - Pontic cases in combination with at least one longer implant. . - Fully edentulous cases with at least one Straumand Plus 4 mm Short Implants in combination with 2 longer . implants in the anterior region and at least four total implants. #### Titanium Ø 3.3 mm implants Ø3.3 mm S and SP RN implants are to be used only for the following indications: Partially dentate jaws with implant-borne, fixed constructions: combine with a 04.1 mm implants and splint the superstructure. Type of Use (Select one or both, as applicable) 区 Prescription Use (Part 21 CFR 801 Subpart D) □ Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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FORM FDA 3881 (6/20) Page 1 of 1 EF PSC Publishing Services (301) 443-6740 {4}------------------------------------------------ ### Straumann® SLActive® Labeling Changes 510(k) Summary ### 510(k) Summary ### Submitter's Contact Information | Submitter: | Straumann USA, LLC<br>60 Minuteman Road<br>Andover, MA 01810<br>Registration No.: 1222315 Owner/Operator No.: 9005052 | |---------------------|----------------------------------------------------------------------------------------------------------------------------------------------| | | On the behalf of: Institut Straumann AG | | | Institut Straumann AG<br>Peter Merian-Weg 12<br>4052 Basel, Switzerland. | | Contact Person: | Jennifer M. Jackson, MS, RAC<br>Sr. Director, Regulatory Affairs and Quality<br>Phone Number: +1-978-747-2509<br>Fax Number: +1-978-747-0023 | | Prepared By: | Camila da Silva Esteves<br>External Consultant | | Date of Submission: | June 21, 2023 | ### Name of the Device | Trade Names: | Straumann® SLActive® labeling changes | |------------------------|---------------------------------------| | Common Name: | Endosseous Dental Implant | | Classification Name: | Endosseous Dental Implant | | Regulation Number: | §872.3640 | | Device Classification: | II | | Product Code(s): | DZE | | Classification Panel: | Dental | | Proprietary Name: | Straumann® SLActive® | {5}------------------------------------------------ ### Straumann® SLActive® Labeling Changes 510(k) Summary ### Predicate Device(s) Primary Predicate: - . K171784 – Straumann Dental Implant System Reference Devices: - K083550 Straumann Dental Implant System . - K111357 Straumann Narrow Neck CrossFit (NNC) 03.3mm Dental Implant System ● - K121131 BL, 04.1mm RC, SLActive® 8mm, TiZr and 10mm, 12, 14mm . - K122855 TL 04.1mm RN, S, SLActive® TiZr 6, 8, 10, 12, 14, 16mm Dental Implants . - K140878 Straumann Bone Level Tapered Implant . - K153758 Straumann Bone Level Tapered Implant . - K162890 BLT 02.9mm SC, SLA or SLActive®, RXD, Loxim, SC Closure Cap and . Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutments - K173961 Straumann BLX Implant System . - K181703 Straumann BLX Line Extension Implants, SRAs and Anatomic Abutments . - K191256 Straumann BLX Ø3.5 mm Implants . - K200586 Straumann TLX Implant System . - K210855 Straumann TLX Implant System . - K202942 Straumann 4 mm Short Implants . - K212533 BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants . - K123784 Straumann Dental Implant System . ### Device Description The SLActive® Implants from the Straumann® Dental Implants System includes: SLActive® and Roxolid®, Standard, Ø3.3 RN, 8, 10, 12, 14, and 16 mm SLActive® and Roxolid®, Standard, Ø4.1 RN, 6, 8, 10, 12, 14, and 16 mm SLActive® and Roxolid®, Standard, Ø4.8 RN, 6, 8, 10, 12, and 14 mm SLActive® and Roxolid®, Standard, Ø4.8 WN, 6, 8, 10, and 12 mm SLActive® and Roxolid®, Standard Plus, Ø3.3 NNC, 8, 10, 12, and 14 mm {6}------------------------------------------------ ### Straumann® SLActive® Labeling Changes 510(k) Summary SLActive® and Roxolid®, Standard Plus, Ø3.3 RN, 8, 10, 12, and 14 mm SLActive® and Roxolid®, Standard Plus, Ø4.1 RN and Ø4.8 RN, 6, 8, 10, 12, and 14 mm SLActive® and Roxolid®, Standard Plus, Ø4.8 WN, 6, 8, 10 and 12 mm SLActive® and Roxolid®, Bone Level, Ø3.3 NC, Ø4.1 RC, and Ø4.8 RC, 8, 10, 12, and 14 mm SLActive® and Roxolid®, Bone Level Tapered, Ø2.9 SC 10, 12 and 14 mm SLActive® and Roxolid®, Bone Level Tapered, Ø3.3 NC, Ø4.1 RC, and Ø4.8 RC, 8, 10, 12, 14. 16 and 18 mm SLActive® and Roxolid®, BLX, Ø3.5 RB, 8, 10, 12, 14, 16, 18 mm SLActive® and Roxolid®, BLX, Ø3.75 RB, Ø4.0 RB, Ø4.5 RB and Ø5.0 RB, 6, 8, 10, 12, 14, 16. 18 mm SLActive® and Roxolid®, BLX, Ø5.5 WB and Ø6.5 WB, 6, 8, 10, 12, 14 and 16 mm SLActive® and Roxolid®, Standard, TLX, Ø3.75 NT, Ø3.75 RT, Ø4.5 NT and Ø4.5 RT, 6, 8, 10, 12, 14, 16 and 18 mm SLActive® and Roxolid®, Standard, TLX, Ø5.5 WT and Ø6.5 WT, 6, 8, 10 and 12 mm SLActive® and Roxolid®, Standard Plus, TLX, Ø3.75 RT, Ø4.5 NT and Ø4.5 RT, 6, 8, 10, 12, 14, 16 and 18 mm SLActive® and Roxolid®, Standard Plus, TLX, Ø5.5 WT and Ø6.5 WT, 6, 8, 10 and 12 mm SLActive® and Roxolid®, Standard Plus Short, Ø4.1 RN and Ø4.8 RN and WN, 4 mm 4 mm Short Implants All listed dental implants have already been cleared under the reference devices 510(k)s. ### Intended Use Straumann® dental implants and abutments are intended for oral implantation to provide a support structure for connected prosthetic devices. ### Indications for Use #### Straumann® BLX Dental Implants, SLActive® Straumann® dental implants are indicated for functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. {7}------------------------------------------------ ### Straumann® SLActive® Labeling Changes ### 510(k) Summary They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multipletooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. #### Straumann® TLX Dental Implants, SLActive® Straumann® dental implants are indicated for the functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. They can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. #### Other Straumann® Tissue Level and Bone Level Dental Implants, SLActive® Straumann® dental implants are indicated for functional and esthetic oral rehabilitation of the upper or lower jaw of edentulous or partially edentulous patients. Unless stated in specific indications, they can be used for immediate, early or late implantation following the extraction or loss of natural teeth. The implants can be placed with immediate function for single-tooth and/or multiple-tooth restorations when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. Specific indications for use ### Straumann® Roxolid® Bone Level Tapered Implant ø 2.9 mm The Straumann® Roxolid® Bone Level Tapered implants ø 2.9 mm are indicated for single-unit reconstruction of incisors in the lower jaw and lateral incisors in the upper jaw. #### Straumann® Roxolid® Standard Plus 4 mm Short Implants Straumann® Roxolid® Standard Plus 4 mm Short Implants are indicated for fixed or removable reconstruction in situations of moderate to severely atrophic jawbone with adequate bone quality that allows primary stability after implant insertion, where a longer implant cannot be placed due to limited vertical bone height. The recommended healing time before loading is between 10 to 12 weeks. Straumann® Roxolid® Standard Plus 4 mm Short Implants are specifically indicated for: Fixed denture prosthesis/splinted units (one implant per unit). {8}------------------------------------------------ ### Straumann® SLActive® Labeling Changes 510(k) Summary Pontic cases in combination with at least one longer implant. Fully edentulous cases with at least one Straumann® Roxolid® Standard Plus 4 mm Short Implants in combination with 2 longer implants in the anterior region and at least four total implants. #### Titanium Ø 3.3 mm implants ø3.3 mm S and SP RN implants are to be used only for the following indications: Partially dentate jaws with implant-borne, fixed constructions: combine with a Ø4.1 mm implants and splint the superstructure. ### Technological Characteristics The technological characteristics of the subject devices are compared to the primary predicate and reference devices in the following tables: | FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE<br>DEVICE | REFERENCE PREDICATE<br>DEVICES | |--------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------| | K Number | K223083 | K171784 | K083550, K111357, K121131, K122855, K140878, K153758, K162890, K173961, K181703, K191256, K200586, K202942, K210855, K212533, K123784 | | Material | Titanium - Zirconium alloy | Titanium - Zirconium alloy<br>Titanium Grade 4 | Titanium-Zirconium alloy | | Surface<br>Treatment | SLActive® - Hydrophilic, sandblasted, large grit, acid etched. | SLActive® - Hydrophilic, sandblasted, large grit, acid etched. | | | Implant to<br>Abutment<br>Connection | TorcFit®<br>CrossFit®<br>SynOcta® | SynOcta®<br>CrossFit® | TorcFit®<br>CrossFit®<br>SynOcta® | | Implant<br>Diameter | 2.9mm, 3.3mm, 3.5mm, 3.75mm, 4.0mm, 4.1mm, 4.5mm, 4.8mm, 5.0mm, 5.5mm, 6.5mm | 3.3mm, 4.1mm and 4.8mm | 2.9mm, 3.3mm, 3.5mm, 3.75mm, 4.0mm, 4.1mm, 4.5mm, 4.8mm, 5.0mm, 5.5mm, 6.5mm | | Implant<br>Length | 4, 6, 8, 10, 12, 14, 16 and<br>18mm | 6, 8, 10, 12, 14, 16 and 18mm | 4, 6, 8, 10, 12, 14, 16 and<br>18mm | | Implant<br>Design | Tissue level (parallel and fully<br>tapered wall)<br>Bone level (parallel, tapered and<br>fully tapered wall) | Tissue level (parallel wall)<br>Bone level (parallel and tapered<br>wall) | Tissue level (parallel and fully<br>tapered wall)<br>Bone level (parallel, tapered and<br>fully tapered wall) | Table 1 – Comparison of subject device versus primary predicate device {9}------------------------------------------------ ### Straumann® SLActive® Labeling Changes 510(k) Summary ### Labeling Changes and Performance Testing The labelling changes that are being presented in this 510(k) were evaluated according to the FDA guidance document "Deciding When to Submit a 510(k) for a Change to an Existing Device". The proposed 510(k) does not intend to introduce new implants neither to modify cleared implants design. The purpose of this premarket notification is to revise the labeling to describe that the results of recent clinical studies on outcomes of SLActive implants in smokers are encouraging (Alsahhaf, 2019, Xiao, 2021, Chen 2017, Sener 2010, Luongo 2016). The proposed claim is supported by a literature review. In addition, changes to the Indications for Use wording were done, as well as general changes to the Instructions for Useto reflect the state-of-the-art of Straumann implant systems data and to improve the readability and clarity of the content without affecting the safety or effectiveness of the devices. Table 2 shows the substantial equivalence discussion for the proposed Indications for Use against the previously approved verbiage. The presented Indications for Use are equivalent to the primary predicate and reference devices. The differences in the wording do not change the application of the devices. All indications allow for implant placement in the jaw, providing support for single-tooth or multipletooth and allowing for immediate loading when good primary stability is achieved. The prosthetic restorations information in some Indications for Use was relocated to the device description for better understanding. The use of 4 or more implants for fully edentulous patients is common knowledge and was removed from some Indications for Use. The new specific Indications for Use for ø 3.3 mm implants provide more details on the recommended clinical procedure. Additionally, the section Precaution of the Instructions for Use brings attention to the use of narrow implants in the molar region. {10}------------------------------------------------ ### Straumann® SLActive® Labeling Changes 510(k) Summary #### Table 2 Indications for Use comparison table * for the purpose of this table, the acronym IFU refers to Instructions for Use | K<br>NUMBER | PROPOSED INDICATIONS FOR USE | PRIMARY PREDICATE DEVICE<br>INDICATIONS FOR USE<br>(K171784) | REFERENCE PREDICATE DEVICE<br>INDICATIONS FOR USE | EQUIVALENCE DISCUSSION | |-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K083550 | IFU: 704333<br>Straumann® dental implants are<br>indicated for functional and esthetic oral<br>rehabilitation of the upper or lower jaw of<br>edentulous or partially edentulous<br>patients.<br>Unless stated in specific indications, theyimplantation following the extraction or<br>loss of natural teeth. The implants can be<br>placed with immediate function for single-<br>tooth and/or multiple-tooth restorations<br>when good primary stability is achieved<br>and with appropriate occlusal loading to<br>restore chewing function.<br>Titanium Ø 3.3 mm implants<br>Ø3.3 mm S and SP RN implants are to be<br>used only for the following indications:<br>Partially dentate jaws with implant-borne,<br>fixed constructions: combine with a Ø4.1<br>mm implants and splint the<br>superstructure. | Straumann® Dental implants are<br>indicated for oral endosteal<br>implantation in the upper and lower jaw<br>arches and for the functional and<br>aesthetic oral rehabilitation of<br>edentulous and partially dentate<br>patients.<br>Straumann® Dental implants are<br>indicated for immediate or early<br>implantation following extraction or loss<br>of natural teeth. Implants can be placed<br>with immediate function on single-tooth<br>and/or multiple-tooth applications when<br>good primary stability is achieved and<br>with appropriate occlusal loading to<br>restore chewing function. The<br>prosthetic restorations are single<br>crowns, bridges and partial or full<br>dentures, which are connected to the<br>implants through the corresponding<br>components (abutments). | Reference predicate - K083550:<br>Straumann® ROXOLID dental implants are<br>suitable for the treatment of oral endosteal<br>implantation in the upper and lower jaw and for<br>the functional and aesthetic oral rehabilitation of<br>edentulous and partially dentate patients<br>(unless specific indications and limitations are<br>present, as stated below). Straumann®<br>ROXOLID dental implants can also be used for<br>immediate or early implantation following<br>extraction or loss of natural teeth. Implants can<br>be placed with immediate function on single-<br>tooth and/or multiple tooth applications when<br>good primary stability is achieved and with<br>appropriate occlusal loading, to restore<br>chewing functions. The prosthetic restorations<br>used are single crowns, bridges and partial or<br>full dentures, which are connected to the<br>implants by the corresponding elements<br>(abutments). When placing implants in the<br>posterior region we recommend using only<br>large diameter implants. In cases of fully<br>edentulous patients, 4 or more implants must<br>be used in immediately loaded cases.<br>Specific indications for small diameter (Ø3.3<br>mm) implants:<br>Because of their reduced mechanical stability,<br>small diameter implants are only used in cases<br>with a low mechanical load. Placement in the<br>molar region is not recommended. | Equivalent<br>All indications allow for implant<br>placement in jaw, providing<br>support for single-tooth or<br>multiple-tooth and allowing for<br>immediate loading when good<br>primary stability is achieved.<br>The prosthetic restorations<br>information was not excluded<br>from the Instructions for Use but<br>relocated to the device<br>description for better<br>understanding.<br>The use of 4 or more implants for<br>fully edentulous patients is<br>common knowledge and were<br>removed from the indications for<br>use.<br>The new specific Indications for<br>Use for Ø 3.3 mm implants<br>provides more details on the<br>recommended clinical procedure.<br>Additionally, the section<br>Precaution of the IFU show<br>brings attention to the use in<br>molar region. | {11}------------------------------------------------ ### Straumann® SLActive® Labeling Changes | K<br>NUMBER | PROPOSED INDICATIONS FOR USE | PRIMARY PREDICATE DEVICE<br>INDICATIONS FOR USE<br>(K171784) | REFERENCE PREDICATE DEVICE<br>INDICATIONS FOR USE | EQUIVALENCE DISCUSSION | |-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K111357 | IFU 704333<br>Straumann® dental implants are<br>indicated for functional and esthetic oral<br>rehabilitation of the upper or lower jaw of<br>edentulous or partially edentulous<br>patients.<br>Unless stated in specific indications, they<br>can be used for immediate, early or late<br>implantation following the extraction or<br>loss of natural teeth. The implants can be<br>placed with immediate function for single-<br>tooth and/or multiple-tooth restorations<br>when good primary stability is achieved<br>and with appropriate occlusal loading to<br>restore chewing function.<br><b>Titanium Ø 3.3 mm implants</b><br>Ø3.3 mm S and SP RN implants are to be<br>used only for the following indications:<br>Partially dentate jaws with implant-borne,<br>fixed constructions: combine with a Ø4.1<br>mm implants and splint the<br>superstructure. | Straumann® Dental implants are<br>indicated for oral endosteal<br>implantation in the upper and lower jaw<br>arches and for the functional and<br>aesthetic oral rehabilitation of<br>edentulous and partially dentate<br>patients. Straumann® Dental implants<br>are indicated for immediate or early<br>implantation following extraction or loss<br>of natural teeth. Implants can be placed<br>with immediate function on single-tooth<br>and/or multiple-tooth applications when<br>good primary stability is achieved and<br>with appropriate occlusal loading to<br>restore chewing function. The<br>prosthetic restorations are single<br>crowns, bridges and partial or full<br>dentures, which are connected to the<br>implants through the corresponding<br>components (abutments). | Reference Predicate - K111357:<br>Straumann® dental implants are suitable for the<br>treatment of oral endosteal implantation in the<br>upper and lower jaw and for the functional and<br>aesthetic oral rehabilitation of edentulous and<br>partially dentate patients. Straumann® dental<br>implants can also be used for immediate or<br>early implantation following extraction or loss of<br>natural teeth. Implants can be placed with<br>immediate function on single-tooth and/or<br>multiple tooth applications when good primary<br>stability is achieved and with appropriate<br>occlusal loading, to restore chewing function.<br>The prosthetic restorations used are single<br>crowns, bridges and partial or full dentures,<br>which are connected to the implants by the<br>corresponding components (abutments). When<br>placing implants in the posterior region, we<br>recommend using only large diameter implants.<br>In cases of fully edentulous patients, 4 or more<br>implants must be used in immediately loaded<br>cases.<br><b>Small Diameter Implants (Ø 3.3 mm)</b><br>Because of their reduced mechanical stability,<br>small diameter implants are only used in cases<br>with low mechanical load. Placement in the<br>moral region is not recommended. | Equivalent<br>All indications allow for implant<br>placement in jaw, providing<br>support for single-tooth or<br>multiple-tooth and allowing for<br>immediate loading when good<br>primary stability is achieved.<br>The prosthetic restorations<br>information was not excluded<br>from the Instructions for Use but<br>relocated to the device<br>description for better<br>understanding.<br>The use of 4 or more implants<br>for fully edentulous patients is<br>common knowledge and were<br>removed from the indications for<br>use. The new specific<br>Indications for Use for Ø 3.3 mm<br>implants provides more details<br>on the recommended clinical<br>procedure. Additionally, the<br>section Precaution of the IFU<br>show brings attention to the use<br>in molar region. | {12}------------------------------------------------ # Straumann® SLActive® Labeling Changes | K<br>NUMBER | PROPOSED INDICATIONS FOR USE | PRIMARY PREDICATE DEVICE<br>INDICATIONS FOR USE<br>(K171784) | REFERENCE PREDICATE DEVICE<br>INDICATIONS FOR USE | EQUIVALENCE DISCUSSION | |-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K121131 | IFU 704333<br>Straumann® dental implants are<br>indicated for functional and esthetic oral<br>rehabilitation of the upper or lower jaw of<br>edentulous or partially edentulous<br>patients.<br>Unless stated in specific indications, they<br>can be used for immediate, early or late<br>implantation following the extraction or<br>loss of natural teeth. The implants can be<br>placed with immediate function for single-<br>tooth and/or multiple-tooth restorations<br>when good primary stability is achieved<br>and with appropriate occlusal loading to<br>restore chewing function. | Straumann® Dental implants are<br>indicated for oral endosteal<br>implantation in the upper and lower jaw<br>arches and for the functional and<br>aesthetic oral rehabilitation of<br>edentulous and partially dentate<br>patients. Straumann® Dental implants<br>are indicated for immediate or early<br>implantation following extraction or loss<br>of natural teeth. Implants can be placed<br>with immediate function on single-tooth<br>and/or multiple-tooth applications when<br>good primary stability is achieved and<br>with appropriate occlusal loading to<br>restore chewing function. The<br>prosthetic restorations are single<br>crowns, bridges and partial or full<br>dentures, which are connected to the<br>implants through the corresponding<br>components (abutments). | Reference Predicate - K121131:<br>The Straumann® dental implants are suitable<br>for the treatment of oral endosteal implantation<br>in the upper and lower jaw and for the functional<br>and esthetic oral rehabilitation of edentulous<br>and partially dentate patients (unless specific<br>indications and limitations are specified).<br>Straumann® dental implants can be used for<br>immediate or early implantation following<br>extraction or loss of natural teeth. Implants can<br>be placed with immediate function on single-<br>tooth and/or multiple tooth applications when<br>good primary stability is achieved and with<br>appropriate occlusal loading, to restore<br>chewing function. The prosthetic restorations<br>are single crown, bridges and partial or full<br>denture, which are connected to the implants by<br>the corresponding elements (abutments).<br>When placing implants in the posterior region,<br>we recommend using only large diameter<br>implants. In cases of fully edentulous patients,<br>4 or more implants must be used in immediately<br>loaded cases. | Equivalent<br>All indications allow for implant<br>placement in jaw, providing<br>support for single-tooth or<br>multiple-tooth and allowing for<br>immediate loading when good<br>primary stability is achieved.<br>The prosthetic restorations<br>information was not excluded<br>from the Instructions for Use but<br>relocated to the device<br>description for better<br>understanding.<br>The use of 4 or more implants for<br>fully edentulous patients is<br>common knowledge and were<br>removed from the indications for<br>use. | {13}------------------------------------------------ # Straumann® SLActive® Labeling Changes | K<br>NUMBER | PROPOSED INDICATIONS FOR USE | PRIMARY PREDICATE DEVICE<br>INDICATIONS FOR USE<br>(K171784) | REFERENCE PREDICATE DEVICE<br>INDICATIONS FOR USE | EQUIVALENCE DISCUSSION | |-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K122855 | IFU 704333<br>Straumann® dental implants are<br>indicated for functional and esthetic oral<br>rehabilitation of the upper or lower jaw of<br>edentulous or partially edentulous<br>patients.<br>Unless stated in specific indications, they<br>can be used for immediate, early or late<br>implantation following the extraction or<br>loss of natural teeth. The implants can be<br>placed with immediate function for single-<br>tooth and/or multiple-tooth restorations<br>when good primary stability is achieved<br>and with appropriate occlusal loading to<br>restore chewing function. | Straumann® Dental implants are<br>indicated for oral endosteal<br>implantation in the upper and lower jaw<br>arches and for the functional and<br>aesthetic oral rehabilitation of<br>edentulous and partially dentate<br>patients. Straumann® Dental implants<br>are indicated for immediate or early<br>implantation following extraction or loss<br>of natural teeth. Implants can be placed<br>with immediate function on single-tooth<br>and/or multiple-tooth applications when<br>good primary stability is achieved and<br>with appropriate occlusal loading to<br>restore chewing function. The<br>prosthetic restorations are single<br>crowns, bridges and partial or full<br>dentures, which are connected to the<br>implants through the corresponding<br>components (abutments). | Reference Predicate - K122855:<br>Straumann® dental implants are suitable for the<br>treatment of oral endosteal implantation in the<br>upper and lower jaw and for the functional and<br>esthetic oral rehabilitation of edentulous and<br>partially dentate patients (unless specific<br>implants and limitations are present, as stated<br>below). Straumann® dental implants can also<br>be used for immediate or early implantation<br>following extraction or loss of natural teeth.<br>Implants can be placed with immediate function<br>on single-tooth and/or multiple tooth<br>applications when good primary stability is<br>achieved and with appropriate occlusal loading,<br>to restore chewing function. The prosthetic<br>restorations used are single crowns, bridges<br>and partial or full dentures, which are<br>connected to the implants by corresponding<br>elements (abutments). When placing implants<br>in the posterior region, we recommend using<br>only larger diameter implants. In cases of fully<br>edentulous patients, 4 or more implants must<br>be used in immediate loaded cases. | Equivalent<br>All indications allow for implant<br>placement in jaw, providing<br>support for single-tooth or<br>multiple-tooth and allowing for<br>immediate loading when good<br>primary stability is achieved.<br>The prosthetic restorations<br>information was not excluded<br>from the Instructions for Use but<br>relocated to the device<br>description for better<br>understanding.<br>The use of 4 or more implants for<br>fully edentulous patients is<br>common knowledge and were<br>removed from the indications for<br>use. | {14}------------------------------------------------ # Straumann® SLActive® Labeling Changes | K<br>NUMBER | PROPOSED INDICATIONS FOR USE | PRIMARY PREDICATE DEVICE<br>INDICATIONS FOR USE<br>(K171784) | REFERENCE PREDICATE DEVICE<br>INDICATIONS FOR USE | EQUIVALENCE DISCUSSION | |-------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K140878 | IFU 704333<br>Straumann® dental implants are<br>indicated for functional and esthetic oral<br>rehabilitation of the upper or lower jaw of<br>edentulous or partially edentulous<br>patients.<br>Unless stated in specific indications, they<br>can be used for immediate, early or late<br>implantation following the extraction or<br>loss of natural teeth. The implants can be<br>placed with immediate function for single-<br>tooth and/or multiple-tooth restorations<br>when good primary stability is achieved<br>and with appropriate occlusal loading to<br>restore chewing function. | Straumann® Dental implants are<br>indicated for oral endosteal<br>implantation in the upper and lower jaw<br>arches and for the functional and<br>aesthetic oral rehabilitation of<br>edentulous and partially dentate<br>patients. Straumann® Dental implants<br>are indicated for immediate or early<br>implantation following extraction or loss<br>of natural teeth. Implants can be placed<br>with immediate function on single-tooth<br>and/or multiple-tooth applications when<br>good primary stability is achieved and<br>with appropriate occlusal loading to<br>restore chewing function. The<br>prosthetic restorations are single<br>crowns, bridges and partial or full<br>dentures, which are connected to the<br>implants through the corresponding<br>components (abutments). | Reference Predicate - K140878:<br>Straumann® dental implants are indicated for<br>oral endosteal implantation in the upper and<br>lower jaw arches for the functional and<br>aesthetic oral rehabilitation of edentulous and<br>partially dentate patients. Straumann® dental<br>implants are also indicated for immediate or<br>early implantation following extraction or loss of<br>natural teeth. Implants can be placed with<br>immediate function on single-tooth and/or<br>multiple tooth applications when good primary<br>stability is achieved and with appropriate<br>occlusal loading, to restore chewing function.<br>The prosthetic restorations used are single<br>crowns, bridges and partial or full dentures,<br>which are connected to the implants through<br>the corresponding components (abutments). In<br>cases of fully edentulous patients, 4 or more<br>implants must be used in immediately loaded<br>cases. | Equivalent<br>All indications allow for implant<br>placement in jaw, providing<br>support for single-tooth or<br>multiple-tooth and allowing for<br>immediate loading when good<br>primary stability is achieved.<br>The prosthetic restorations<br>information was not excluded<br>from the Instructions for Use but<br>relocated to the device<br>description for better<br>understanding.<br>The use of 4 or more implants for<br>fully edentulous patients is<br>common knowledge and were<br>removed from the indications for<br>use. | {15}------------------------------------------------ # Straumann® SLActive® Labeling Changes | K<br>NUMBER | PROPOSED INDICATIONS FOR USE | PRIMARY PREDICATE DEVICE<br>INDICATIONS FOR USE<br>(K171784) | REFERENCE PREDICATE DEVICE<br>INDICATIONS FOR USE | EQUIVALENCE DISCUSSION | |-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K153758 | Straumann® dental implants are<br>indicated for functional and esthetic oral<br>rehabilitation of the upper or lower jaw of<br>edentulous or partially edentulous<br>patients.<br>Unless stated in specific indications, they<br>can be used for immediate, early or late<br>implantation following the extraction or<br>loss of natural teeth. The implants can be<br>placed with immediate function for single-<br>tooth and/or multiple-tooth restorations<br>when good primary stability is achieved<br>and with appropriate occlusal loading to<br>restore chewing function. | Straumann® Dental implants are<br>indicated for oral endosteal<br>implantation in the upper and lower jawarches and for the functional and<br>aesthetic oral rehabilitation of<br>edentulous and partially dentate<br>patients. Straumann® Dental implants<br>are indicated for immediate or early<br>implantation following extraction or loss<br>of natural teeth. Implants can be placed<br>with immediate function on single-tooth<br>and/or multiple-tooth applications when<br>good primary stability is achieved and<br>with appropriate occlusal loading to<br>restore chewing function. The<br>prosthetic restorations are single<br>crowns, bridges and partial or full<br>dentures, which are connected to the<br>implants through the corresponding<br>components (abutments). | Reference Predicate - K153758<br>Straumann® dental implants are indicated for<br>oral endosteal implantation in the upper and<br>lower jaw arches for the functional and<br>aesthetic oral rehabilitation of edentulous and<br>partially dentate patients. Straumann® dental<br>implants are also indicated for immediate or<br>early implantation following extraction or loss of<br>natural teeth. Implants can be placed with<br>immediate function on single-tooth and/or<br>multiple tooth applications when good primary<br>stability is achieved and with appropriate<br>occlusal loading to restore chewing function.<br>The prosthetic restorations used are single<br>crowns, bridges and partial or full dentures,<br>which are connected to the implants through<br>the corresponding components (abutments). | Equivalent<br>All indications allow for implant<br>placement in jaw, providing<br>support for single-tooth or<br>multiple-tooth and allowing f…