Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & 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 Senior Director, Regulatory Affairs and Quality Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810 Re: K222836 Trade/Device Name: Strauman® Variobase® Abutments and n!ce® Zirconia Discs Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, EIH Dated: February 14, 2023 Received: February 14, 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) K222836 #### Device Name Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs #### Indications for Use (Describe) Straumann® Variobase® Abutments The Straumann® Variobase® abutments are prosthetic components placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® abuments are indicated for screw retained single tooth or cement-retained single tooth and bridge restorations. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize, and form the soft tissue during the healing phase. Temporary restorations are indicated to be placed out of occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacturing by a validated milling center. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------|-----------------------------------------------| | <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | CONTINUE ON A SEPARATE PAGE IF NEEDED#### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## Indications for Use #### 510(k) Number (if known) K222836 #### Device Name Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs Indications for Use (Describe) Straumann® nice® Zirconia discs Once finalized into a suitable design: n!ce® Zirconia LT and n!ce® Zirconia HT restorations are indicated for inlays, onlays, veneers, crowns, and bridges up to full arch. n!ce® Zirconia XT restorations are indicated for inlays, onlays, veneers, crowns, and bridges up to 3 units. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| | | | X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs 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<br><br>On the behalf of:<br>Institut Straumann AG<br>Peter Merian-Weg 12<br>4002 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 &<br>Alternate Contact: | Renate Reiss<br>Associate Director Regulatory Affairs and Compliance<br>Institut Straumann AG<br>Phone number: +41 61 965 1260 | | Date of Submission: | May 15, 2023 | ## Name of the Device | Trade Names: | Straumann® Variobase® Abutments and Straumann® n!ce®<br>Zirconia discs | |------------------------|------------------------------------------------------------------------| | Common Name: | Straumann® Variobase® Abutments and Straumann® n!ce®<br>Zirconia discs | | Classification Name: | Endosseous Dental Implant Abutment | | Regulation Number: | §872.3630 | | Device Classification: | II | | Product Code(s): | Primary product code NHA<br>Secondary product code EIH | | Classification Panel: | Dental | {5}------------------------------------------------ ## Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs #### 510(k) Summary ## Predicate Device(s) #### Primary Predicate: - . K120822 – Straumann Cares Variobase Abutments NNC, Straumann Cares Variobase Abutments RN, Straumann Cares Variobase Abutments WN, ST #### Reference Devices: - . K170356 - Straumann Variobase Abutments - K190082 Straumann BLX Variobase Abutment . - K200586 Straumann TLX Implant System . - K072569 Metoxit Cam-Blanks . - K170050 Z-CAD smile . #### Device Description The purpose of this bundled premarket notification is to obtain regulatory clearance for the Straumann subject devices: - . Straumann® Variobase® Abutments (NHA) A two-piece abutment consisting of a Variobase (bottom half) and ceramic component (top half), - Straumann® n!ce® Zirconia discs (EIH) . #### Straumann® Variobase® Abutments Straumann Variobase Abutments are two-piece abutments. The Variobase is the bottom half of the two-piece abutment. The top half of the two-piece abutment is a CAD/CAM designed and manufactured ceramic component milled from Straumann n!ce Zirconia (ZrQ2), also subject to this submission as a material suitable for fabrication of the coping or crown that, when bonded to the previously cleared Variobase abutment base, forms a finished dental prosthesis. All digitally designed ceramic components for use with the Straumann Variobase abutments are intended to be sent to Straumann for manufacture at a validated milling center. The following materials are available within the digital workflow for the manufacturing of dental prosthetic restorations: (i) low translucency (LT), (ii) high translucency (HT), and (iii) extra high translucency (XT) n!ce Zirconia. The materials come in various shades (excluding White). . Straumann Variobase abutments are available to interface with the following Straumann dental {6}------------------------------------------------ ## Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs 510(k) Summary implant platforms: Regular Neck (RN), Wide Neck (WN), Regular CrossFit (RC), Wide Base (WB), Regular Base (RB), Narrow TorcFit (NT), Regular TorcFit (RT), Wide TorcFit (WT) and were previously cleared (K120822, K170356, K190082 and K200586). #### Straumann® n!ce® Zirconia discs Straumann n!ce Zirconia (ZrQ2) discs are intended to be milled to produce prosthetic restorations for prepared natural teeth and endosseous dental implant abutments. The material is suitable for use in inlays, onlays, veneers, copings, crowns, and multi-unit restorations. Straumann n!ce Zirconia (ZrO2) discs will be offered in 3 translucencies: low translucency (LT), high translucency (HT) and extra high translucency (XT). #### Intended Use #### Straumann® Variobase® Abutments Prosthetic components directly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. Straumann® n!ce® Zirconia discs Straumann® n!ce® Zirconia discs are intended to be milled to produce ceramic restorations to restore natural teeth or to be placed on top of abutments. #### Indications for Use #### Straumann® Variobase® Abutments The Straumann® Variobase® abutments are prosthetic components placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® abutments are indicated for screw retained single tooth or cement-retained single tooth and bridge restorations. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize, and form the soft tissue during the healing phase. Temporary restorations are indicated to be placed out of occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacturing by a validated milling center. {7}------------------------------------------------ ## Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs 510(k) Summary #### Straumann® n!ce® Zirconia discs Once finalized into a suitable design: n!ce® Zirconia LT and n!ce® Zirconia HT restorations are indicated for inlays, onlays, veneers, crowns, and bridges up to full arch. n!ce® Zirconia XT restorations are indicated for inlays, onlays, veneers, crowns, and bridges up to 3 units. ## Technological Characteristics The technological characteristics of the subject devices are compared to the primary predicate and reference devices in the following tables. #### Straumann® Variobase® Abutments Straumann Variobase Abutments are two-piece abutments. The Variobase is the bottom half of the two-piece abutment and is identical to the predicate devices. The top half of the two-piece abutment, the ceramic component milled from Straumann n!ce Zirconia (ZrQz), differs only in the chemical composition. Minor changes in the chemical composition result in a variation of the shade to achieve the desired esthetic color shade while physical requirements comply to ISO 6872. The indications for use statement slightly differs in wording, where the descriptive term prosthetic components is used interchangeably with two-piece dental abutment or titanium base. #### Straumann® n!ce® Zirconia discs The Straumann n!ce Zirconia discs differ only in the chemical composition of the milling discs. Minor changes in the chemical composition result in a variation of the shade to achieve the desired esthetic color shade while physical requirements comply to ISO 6872. The Indications for Use statement for the subject device is phrased differently but has the same meaning as the reference devices. {8}------------------------------------------------ # Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs 510(k) Summary | Feature | Proposed Device | Primary Predicate | Reference Device | Reference Device | Reference Device | |---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | K222836 | K120822 | K170356 | K190082 | K200586 | | Indications for Use | The Straumann® Variobase®<br>abutments are prosthetic<br>components placed onto<br>Straumann dental implants to<br>provide support for customized<br>prosthetic restorations.<br>Straumann® Variobase®<br>abutments are indicated for<br>screw retained single tooth or<br>cement-retained single tooth<br>and bridge restorations. A<br>temporary restoration can be<br>used prior to the insertion of<br>the final components to<br>maintain, stabilize, and form<br>the soft tissue during the<br>healing phase. Temporary<br>restorations are indicated to be<br>placed out of occlusion. Final<br>abutments and restorations<br>may be placed into occlusion<br>when the implant is fully<br>osseointegrated. All digitally<br>designed copings and/or<br>crowns for use with the<br>Straumann® Variobase®<br>Abutment system are intended<br>to be sent to Straumann for<br>manufacturing by a validated<br>milling center. | The Straumann® CARES®<br>Variobase™ Abutment is a<br>two-piece dental abutment<br>consisting of the Straumann®<br>Variobase™ Abutment and the<br>Straumann® CARES®<br>Variobase™ Coping which is<br>intended to be placed onto<br>Straumann dental implants to<br>provide support for prosthetic<br>reconstruction such as crowns<br>and bridges. Straumann®<br>CARES® Variobase™<br>Abutments are indicated for<br>screw-retained single tooth or<br>cement-retained single tooth<br>and bridge restorations.<br>The Straumann® CARES®<br>Variobase™ Coping polycon®<br>ae in combination with the<br>Straumann® Variobase™<br>Abutment is indicated for<br>temporary (up to 180 days)<br>dental restoration of a<br>Straumann dental implant. | The Straumann Variobase<br>Abutment is a titanium base<br>placed onto Straumann dental<br>implants to provide support for<br>customized prosthetic<br>restorations. Straumann<br>Variobase Abutments are<br>indicated for screw-retained<br>single tooth or cement-retained<br>single tooth and bridge<br>restorations. All digitally<br>designed copings and/or<br>crowns for use with the<br>Straumann Variobase<br>abutment system are intended<br>to be sent to Straumann for<br>manufacture at a validated<br>milling center. | Straumann® Variobase®<br>prosthetic components directly<br>or indirectly connected to the<br>endosseous dental implant are<br>intended for use as an aid in<br>prosthetic rehabilitations. The<br>prosthetic restoration (crowns)<br>can be cemented onto the<br>Straumann® Variobase®<br>prosthetic components. A<br>temporary restoration can be<br>used prior to the insertion of<br>the final components to<br>maintain, stabilize, and shape<br>the soft tissue during the<br>healing phase. They must be<br>placed out of occlusion. Final<br>abutments and restorations<br>may be placed into occlusion<br>when the implant is fully<br>osseointegrated. All digitally<br>designed copings and/or<br>crowns for use with the<br>Straumann® Variobase®<br>Abutment system are intended<br>to be sent to Straumann for<br>manufacture at a validated<br>milling center | Straumann Variobase<br>prosthetic components directly<br>connected to the endosseous<br>dental implant are intended for<br>use as an aid in prosthetic<br>rehabilitations. The prosthetic<br>restoration (crowns) can be<br>cemented onto the Straumann<br>Variobase prosthetic<br>components. A temporary<br>restoration can be used prior to<br>the insertion of the final<br>components to maintain,<br>stabilize and shape the soft<br>tissue during the healing<br>phase; they must be placed out<br>of occlusion. Final abutments<br>and restorations may be<br>placed into occlusion when the<br>implant is fully<br>osseointegrated. All digitally<br>designed copings and/or<br>crowns for use with the<br>Straumann Variobase<br>Abutment system are intended<br>to be sent to Straumann for<br>manufacture at a validated<br>milling center | | Ti-base model | •RN (Regular Neck)<br>•WN (Wide Neck)<br>•RC (Regular CrossFit)<br>•RB/WB (Regular Base/Wide<br>Base)<br>•WB (Wide Base)<br>•NT (Narrow TorcFit)<br>•RT (Regular TorcFit)<br>•WT (Wide TorcFit) | •RN<br>•WN<br>•RC | •RN<br>•WN<br>•RC | •RB/WB<br>•WB | •NT<br>•RT<br>•WT | {9}------------------------------------------------ # Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs | | 510(k) Summary | |--|----------------| |--|----------------| | Feature | Proposed Device | Primary Predicate | Reference Device | Reference Device | Reference Device | FEATURE | PROPOSED DEVICE | REFERENCE DEVICE | REFERENCE DEVICE | |--------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | K222836 | K120822 | K170356 | K190082 | K200586 | K Number | K222836 | K170050 | K072569 | | Coping material<br>CAD design limits:<br>Minimum wall<br>thickness [mm]<br>Coping crown angulation [°]<br>(min. GH included in stock<br>devices) | n!ce Zirconia LT<br>0.4 mm<br>30°<br>n!ce Zirconia HT<br>0.4 mm<br>30°<br>n!ce Zirconia XT<br>0.5 mm<br>30° | Zerion LT<br>0.4 mm<br>30° | Zerion ML<br>0.8 mm<br>30°<br>Zerion UTML<br>0.5 mm<br>30° | Zerion LT, Zerion ML<br>0.4 mm<br>30°<br>Zerion UTML<br>0.5 mm<br>30° | Zerion LT, Zerion ML<br>0.4 mm<br>30°<br>Zerion UTML<br>0.5 mm<br>30° | Indication<br>for use | n!ce® Zirconia LT and<br>n!ce® Zirconia HT<br>restorations are<br>indicated for inlays,<br>onlays, veneers,<br>crowns, and bridges<br>up to full-arch.<br>Zirconia XT<br>restorations are<br>indicated for inlays,<br>onlays, veneers,<br>crowns and bridges up<br>to 3 units. | METOXIT Z-CAD®<br>smile blanks are<br>indicated for the<br>preparation of full<br>ceramic crowns,<br>inlays, onlays, veneers<br>and 3 unit bridges in<br>the anterior area. All<br>white Z-CAD® smile<br>blanks are indicated to<br>be coloured with Z-<br>CAD® Liquid smile-TC<br>The Z-CAD® Liquid<br>smile-TC will be used<br>to dye white pre-<br>sintered zirconia<br>restorations milled<br>from Z-CAD® smile<br>blanks in the dental<br>field. | Metoxit blanks are indicated for use<br>as a substructure for porcelain<br>fused ceramic fixed dental<br>restorations. Limitations are listed<br>in Table 1<br><br>All blanks are solely by or on the<br>order of a dental professional.<br>They are not for use by the general<br>public or over-the-counter. | | Zirconia class according to<br>ISO 6872 | LT and HT<br>5<br>XT:<br>4 | Zerion LT<br>5 | Zerion ML<br>5<br>Zerion UTML<br>4 | Zerion LT, Zerion ML<br>5<br>Zerion UTML<br>4 | Zerion LT, Zerion ML<br>5<br>Zerion UTML<br>4 | Zirconia<br>class<br>according to<br>ISO 6872 | LT and HT:<br>5<br>XT<br>4 | Z-CAD® smile<br>4 | Z-CAD HD and One4All<br>5 | | Flexural strength (MPa) | LT and HT:<br>≥800<br>XT:<br>≥500 | Zerion LT<br>≥800 | Zerion ML<br>≥800<br>Zerion UTML<br>≥500 | Zerion ML<br>≥800<br>Zerion UTML<br>≥500 | Zerion ML<br>≥800<br>Zerion UTML<br>≥500 | Flexural<br>strength<br>[MPa] | LT and HT<br>≥800<br>XT<br>≥500 | METOXIT Z-CAD®<br>smile<br>≥500 | Z-CAD HD and One4All<br>≥800 | | Workflow/technique | CAD design (CARES Visual)<br>21 CFR 820 centralized<br>manufacturing (milling) | CAD design (CARES Visual)<br>21 CFR 820 centralized<br>manufacturing (milling) | CAD design (CARES Visual)<br>21 CFR 820 centralized<br>manufacturing (milling) | CAD design (CARES Visual)<br>21 CFR 820 centralized<br>manufacturing (milling) | CAD design (CARES Visual)<br>21 CFR 820 centralized<br>manufacturing (milling) | Chemical<br>composition | LT<br>ZrO2 + HfO2 + Y2O3: ≥ 98%<br>Y2O3: ≤5.4%<br>Al2O3: <0.4%<br>HT<br>ZrO2 + HfO2 + Y2O3: ≥<br>98.0%<br>Y2O3: ≤ 7.5%<br>Al2O3: ≤ 0.1%<br>XT<br>ZrO2 + HfO2 + Y2O3: ≥<br>98.0%<br>Y2O3: ≥7.8%<br>Al2O3:≤0.1%<br>Other oxides: < 2.0% | XT<br>ZrO2 + HfO2 + Y2O3: ≥<br>98.0%<br>Y2O3: 3: ≥7.8%<br>Al2O3: ≤0.1%<br>Other oxides: < 2.0% | LT<br>ZrO2 + HfO2 + Y2O3: ≥ 98.0%<br>Y2O3: ≤ 6%<br>Al2O3: ≤ 0.5%<br>HT<br>ZrO2 + HfO2 + Y2O3: ≥ 98.0%<br>Y2O3: ≤7.5 %<br>Al2O3: ≤ 0.5 % | | Geometry | Ø98.5 mm discs in<br>different heights from<br>12 - 30 mm | Ø98.5 mm discs in<br>different heights from<br>10 - 25 mm | Ø98.5 mm discs in different heights<br>from 10 - 25 mm | | | | | | | Table 1 – Comparison of Strauman® Variobase® Abutments (subject device) versus primary predicate and reference devices {10}------------------------------------------------ # Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs ## 510(k) Summary Image /page/10/Figure/4 description: The image shows the title of a table. The title is "Table 2 – Comparison of n!ce Zirconia discs (subject device) versus reference devices". The table will likely compare the n!ce Zirconia discs to other reference devices. {11}------------------------------------------------ ## Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs 510(k) Summary ## Performance Testing #### Straumann® Variobase® Abutments Dynamic fatique and static strength tests were conducted according to ISO 14801 and the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and demonstrated the two-piece Straumann Variobase Abutments with Straumann n!ce Zirconia are equivalent to the primary predicate and reference devices. The material of the bottom half of the Variobase Abutments is identical to the primary predicate device, therefore, no new issues regarding biocompatibility were raised. The top half of the twopiece abutment, the ceramic component milled from Straumann n!ce Zirconia (ZrO2), differs only in the chemical composition, therefore, biocompatibility was confirmed with chemical characterization and in-vitro cytotoxicity according to ISO 10993-12, and 10993-18. The sterilization process for the subject devices as recommended in the labeling was validated according to ISO 17665-1, ISO 17665-2, and applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015". #### Straumann® n!ce® Zirconia discs The Straumann n!ce Zirconia discs are subject to ISO 6872, Dentistry - Ceramic materials. According to ISO 6872 dental ceramics are classified according to their recommended clinical indication and their mechanical properties. The requirements listed apply as per ISO 6872: Uniformity, freedom from extraneous materials, radioactivity, flexural strength, chemical solubility, CTE (coefficient of thermal expansion) and shrinkage factor. The Straumann n!ce Zirconia (ZrQ2) discs are similar to the reference devices cleared in K072569 and K170050, therefore, no new issues regarding biocompatibility were raised. The ceramic component milled from Straumann n!ce Zirconia (ZrO2) discs were evaluated for chemical characterization and in-vitro cytotoxicity according to ISO 10993-5, . 10993-12 and 10993-18. #### Conclusion The conclusion drawn from the nonclinical tests demonstrates that the subject devices in 510(k) submission K222836, the Straumann Variobase Abutments and Straumann n!ce Zirconia discs, {12}------------------------------------------------ ## Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs ## 510(k) Summary are as safe, as effective, and performs as well as the legally marketed primary predicate device and reference devices cleared under K120822, K190082, K170356, 200586, K170050, and K072569. The documentation submitted in this premarket notification demonstrates the subject devices are substantially equivalent to the primary predicate and reference devices.