Straumann CARES M-Series CAD/CAM System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810 Re: K203456 Trade/Device Name: Straumann® CARES M-Series CAD/CAM System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, PNP Dated: June 7, 2021 Received: June 8, 2021 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 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}------------------------------------------------ # DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use 510(k) Number (if known) K203456 #### Device Name: #### Straumann® CARES M-Series CAD/CAM System Indications for Use (Describe) The Straumann CARES M-Series CAD/CAM System is indicated for the design and fabrication of single or multiple-unit implant-borne prosthetics for the restoration of partially or fully edentulous mandibles and maxillae. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners or Extra-Oral Scanners, CAD software, CAM software, restoration material blanks, milling machines and associated tooling and accessories. The system is used to design and fabricate CAD/CAM milled coping, crown and bridge restorations to be cemented onto Straumann® Variobase® Abutments, as well as milled abutments to be affixed to the endosseous dental implants of the Straumann® Dental Implant System using a basal screw. Type of Use (Select one or both, as applicable) 図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 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." Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. {3}------------------------------------------------ ## Straumann® CARES M-Series CAD/CAM System 510(k) Summary # 510(k) Summary ### Submitter's Contact Information | Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG)<br>60 Minuteman Road<br>Andover, MA 01810<br>Registration No.: 1222315 Owner/Operator No.: 9005052 | | | |-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--| | On behalf of: | Institut Straumann AG<br>Peter Merian Weg, 12<br>CH-4002 Basel, Switzerland | | | | Contact Person: | Jennifer M. Jackson, MS<br>Director of Regulatory Affairs and Quality<br>Phone Number: +1-978-747-2509<br>Fax Number: +1-978-747-0023 | | | | Prepared By &<br>Alternate Contact: | Gordon Dodds<br>Manager Design Control QM<br>Etkon GmbH<br>Phone number: +49 89 30 90 75 291<br>Fax number: +49 89 30 90 75 211 | | | | Date of Submission: | June 22, 2021 | | | ### Name of the Device | Trade Names: | Straumann® CARES M-Series CAD/CAM System | |------------------------|------------------------------------------| | Common Name: | Endosseous dental implant abutment | | Classification Name: | Endosseous dental implant abutment | | Regulation Number: | 21 CFR 872.3630 | | Device Classification: | II | | Product Code(s): | NHA, PNP | | Classification Panel: | Dental | {4}------------------------------------------------ ### Straumann® CARES M-Series CAD/CAM System 510(k) Summary ### Predicate Device(s) Primary Predicate: - . K171649 – Straumann® CARES M-Series CADCAM System Reference Devices: - . K190040 – Straumann BLX Line Extension - New Abutments - K190082 Straumann® BLX Variobase® Abutment . - K 190662 MRI Compatibility for Existing Straumann Dental Implant Systems . ### Device Description The Straumann CARES M-Series CAD/CAM System is intended for the design and fabrication of dental restorations by dental laboratories by means of a digital workflow. The workflow is unchanged from the primary predicate K171649. This premarket notification is introducing the Straumann Variobase Abutments for the BLX implant to abutment interface to the previously cleared workflow. The Straumann CARES M-Series CAD/CAM System employs optical impression files that document the topographical characteristics of teeth, traditional dental impressions, or stone models. The Straumann CARES Visual CAD software then allows the design of the desired restorations. The CAM software converts the digital restoration design into the tooling and tool path commands needed to fabricate the restoration. The CAM software also allows multiple restoration files to be combined (nested) in order to maximize the use of dental material blanks. The milling command file is encrypted prior to transfer to the M-Series mill; this encryption ensures that files generated using other CAD or CAM software cannot be used with the M-Series mill. The user will load the milling command file into the M-Series mill where it is decoded. The user loads the appropriate dental material blank and initiates the milling operation. This premarket notification includes restorations (copings, and bridges) manufactured from Zolid HT/Zolid SHT materials for cementation on Straumann Variobase Abutments for the BLX implant system. The BLX dental implant platforms include RB (Regular Base) and RB/WB (Regular Base/Wide Base). The combination of the coping, crown, or bridge and the Variobase Abutment component make up a two-piece abutment assembly, which is used in conjunction with endosseous dental implants for single or multiple tooth dental prostheses. {5}------------------------------------------------ ## Straumann® CARES M-Series CAD/CAM System #### 510(k) Summary The digital workflow using the Straumann CARES M-Series CAD/CAM System includes the use of the following products: #### Dental Scanner(s) The Straumann CARES M-Series CAD/CAM system can accept files generated using the following devices (note that these are not subject devices to this submission): - Dental Wings Intra-Oral Scanner, DWIO . - Dental Wings 3-Series & 7-Series desktop scanners (extra-oral) . - Straumann CARES CS2 scanner (extra-oral) . The dental scanner takes optical impressions that document the topographical characteristics of teeth, traditional dental impressions, or stone models. This includes the location and orientation of dental implants or abutments when a Scanbody is employed during the scan. ### CARES Visual CAD Software The CARES Visual software is a dental CAD application that allows the user to digitally design dental restorations, based on information that was acquired by a dental scanner. As a result of the design process and the indication and material dependent dimensional limits, a threedimensional geometry is created that is linked to the selected restorative material/milling blank. The use of the Straumann manufacturer provided digital device models assures the accuracy of the interfaces between the designed restoration and the abutment or implant being restored. #### CARES Visual CAM Module The CAM interface module converts the three-dimensional geometry into milling machine control data. The CAM software uses the digital restoration geometry information and the material selection to define the tools to be used, the paths the tools are to follow to re-create the digital geometry in physical form and the speed and feed rates of the mill and the tooling. The CAM software also allows for multiple restoration files to fit within the geometry of a single dental material blank (a process referred to as nesting) in order to maximize the use of dental material blanks. The completed CAM file is encrypted prior to being output for transfer to the milling machine. This encryption ensures that files generated using other CAD or CAM software cannot be used with the M-Series mill. This is a means of assuring that only the validated product configuration is used. {6}------------------------------------------------ ## Straumann® CARES M-Series CAD/CAM System 510(k) Summary #### Straumann M-Series Milling Machine The milling machine receives the CAM file from the CAM software. The user will load the CAM file into the M-Series mill where it is decoded. The user mounts the appropriate dental material blank, tools and burs. For certain materials the user will also employ a cutting fluid that acts as a lubricant and coolant for the milling operation. Once the machine is fully configured, the user initiates the milling operation. #### Sintering Furnace - Straumann Therm ● Some restoration materials are provided in a green (i.e. partially crystallized) state or are combined with a polymeric binder material. This is typically done to make the machining process easier and to increase tool life. These materials must undergo a sintering process affer milling in order to achieve their final form. This is carried out in a sintering furnace. The milled geometries, in the materials that require sintering, are larger than the finished restoration to account for the shrinkage that will occur during sintering. This scaling is included in the CAD software as a material specific parameter. The CAD software will scale the digital restoration design using this parameter prior to transfer of the data to the CAM software in order to assure that the final, sintered restoration accurately reflects the digital design. #### Restoration Material Milling Blanks A selection of milling blanks is available for use with the Straumann CARES M-Series CAD/CAM system. The materials and their design control limits are identified in Table 1. | Material Name | Material | Minimum Post<br>Height (mm) | Maximum<br>Angulation | Minimum Wall<br>Thickness (mm) | |-------------------|----------|-----------------------------|-----------------------|--------------------------------| | Zolid HT | ZrO2 | 4.0 | 30° | 0.6 | | Zolid SHT | ZrO2 | 4.0 | 30° | 0.95 | | Zolid HT Preshade | ZrO2 | 4.0 | 30° | 0.6 | Table 1 – Materials with design control limits for use with Straumann BLX Variobase Abutments ### Indications for Use The Straumann CARES M-Series CAD/CAM System is indicated for the design and fabrication of single or multiple-unit implant-borne prosthetics for the restoration of partially or fully edentulous mandibles and maxillae. The system integrates multiple components of the digital {7}------------------------------------------------ ## Straumann® CARES M-Series CAD/CAM System ### 510(k) Summary dentistry workflow: scan files from Intra-Oral Scanners or Extra-Oral Scanners, CAD software, CAM software, restoration material blanks, milling machines and associated tooling and accessories. The system is used to design and fabricate CAD/CAM milled coping, crown and bridge restorations to be cemented onto Straumann® Variobase® Abutments, as well as milled abutments to be affixed to the endosseous dental implants of the Straumann® Dental Implant System using a basal screw. ### Technological Characteristics The technological characteristics of the subject devices are compared to the primary predicate device, Straumann CARES M-Series CAD/CAM System, and the reference devices in Table 2. The main technological difference is the implant to abutment interface of the Variobase Abutments. The BLX Variobase Abutments were cleared previously for centralized manufacturing at a Straumann Validated Milling Center with different restoration materials in K190040 and K190082. The in-lab workflow and the restoration materials (Zolid HT and Zolid SHT) are identical to the primary predicate. K190662 is not included in Table 2 and is referenced for the MRI compatibility only. {8}------------------------------------------------ # Straumann® CARES M-Series CAD/CAM System | FEATURE | SUBJECT DEVICE | PRIMARY PREDICATE DEVICE | REFERNCE DEVICE | REFERENCE DEVICE | EQUIVALENCE | |-------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------| | | K203456 | K171649 | K190082 | K190040 | DISCUSSION | | Indications for<br>Use | The Straumann CARES M-Series<br>CAD/CAM System is indicated for<br>the design and fabrication of<br>single or multiple-unit implant-<br>borne prosthetics for the<br>restoration of partially or fully<br>edentulous mandibles and<br>maxillae. The system integrates<br>multiple components of the digital<br>dentistry workflow: scan files from<br>Intra-Oral Scanners or Extra-Oral<br>Scanners, CAD software, CAM<br>software, restoration material<br>blanks, milling machines and<br>associated tooling and<br>accessories. The system is used<br>to design and fabricate<br>CAD/CAM milled coping, crown<br>and bridge restorations to be<br>cemented onto Straumann®<br>Variobase® Abutments, as well as<br>milled abutments to be affixed to<br>the endosseous dental implants<br>of the Straumann® Dental Implant<br>System using a basal screw. | The Straumann CARES M-Series<br>CAD/CAM System is indicated for<br>the design and fabrication of<br>single or multiple-unit implant-<br>borne prosthetics for the<br>restoration of partially or fully<br>edentulous mandibles and<br>maxillae. The system integrates<br>multiple components of the digital<br>dentistry workflow: scan files from<br>Intra-Oral Scanners or Extra-Oral<br>Scanners, CAD software, CAM<br>software, restoration material<br>blanks, milling machines and<br>associated tooling and<br>accessories. The system is used<br>to design and fabricate<br>CAD/CAM milled coping, crown<br>and bridge restorations to be<br>cemented onto Straumann®<br>Variobase® Abutments, as well as<br>milled abutments to be affixed to<br>the endosseous dental implants<br>of the Straumann® Dental Implant<br>System using a basal screw. | Straumann® Variobase®<br>prosthetic components directly or<br>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 the<br>final components to maintain,<br>stabilize and shape the soft<br>tissue during the healing phase;<br>they must be placed out of<br>occlusion. Final abutments and<br>restorations may be placed into<br>occlusion when the implant is<br>fully osseointegrated. All digitally<br>designed copings and/or crowns<br>for use with the Straumann®<br>Variobase® Abutment system are<br>intended to be sent to Straumann<br>for manufacture at a validated<br>milling center. | Straumann BLX Healing Abutments for Bars<br>and Bridges<br>Straumann Healing abutments are indicated to<br>be placed in the patient's mouth at the end of<br>the implant placement to protect the inner<br>configuration of the implant and to form,<br>maintain and stabilize the soft tissue during the<br>healing process.<br>Healing abutments should be used only with<br>suitable implant connections.<br>Healing components have a maximum duration<br>of usage of 6 months.<br>Straumann BLX Temporary Abutments for<br>Bars and Bridges<br>Prosthetic components directly or indirectly<br>connected to the endosseous dental implant are<br>intended for use as an aid in prosthetic<br>rehabilitations. Temporary components can be<br>used prior to the insertion of the final<br>components to maintain, stabilize and shape<br>the soft tissue during the healing phase; they<br>may not be placed into occlusion. Final<br>abutments may be placed into occlusion when<br>the implant is fully osseointegrated.<br>BLX Temporary Abutments have a maximum<br>duration of usage of 180 days.<br>Straumann BLX Variobase Abutments for<br>Bar and Bridges<br>Straumann® Variobase® prosthetic components<br>directly or indirectly connected to the<br>endosseous dental implant are intended for use<br>as an aid in prosthetic rehabilitations. The<br>prosthetic restoration (bridge or overdenture)<br>can be cemented on the Straumann®<br>Variobase® prosthetic components. A<br>temporary restoration can be used prior to the<br>insertion of the final components to maintain,<br>stabilize and form the soft tissue during the<br>healing phase. They may not be placed into | Identical to primary<br>predicate | | FEATURE | SUBJECT DEVICE<br>K203456 | PRIMARY PREDICATE DEVICE<br>K171649 | REFERNCE DEVICE<br>K190082 | REFERENCE DEVICE<br>K190040 | EQUIVALENCE<br>DISCUSSION | | | | | | occlusion. Final abutments and restorations<br>may be placed into occlusion when the implant<br>is fully osseointegrated.<br>Straumann BLX Variobase Abutments AS<br>The Straumann Variobase for Crown AS is a<br>titanium base placed onto Straumann dental<br>implants to provide support for customized<br>prosthetic restorations. Straumann Variobase<br>for Crown AS are indicated for screw retained<br>single tooth or cement-retained single tooth and<br>bridge restorations. A temporary restoration can<br>be used prior to the insertion of the final<br>components to maintain, stabilize and form the<br>soft tissue during the healing phase. Temporary<br>restorations are indicated to be placed out of<br>occlusion. All digitally designed copings and/or<br>crowns for use with the Straumann Variobase<br>for Crown AS are intended to be sent to<br>Straumann for manufacture at a validated<br>milling center.<br>Straumann BLX Novaloc Abutments<br>The Straumann® Retentive System is indicated<br>for the attachment of full or partial dentures on<br>Straumann dental implants. | | | | | | | Straumann BLX CARES Abutments<br>The Straumann CARES Abutments are in-<br>dicated for single tooth replacement and<br>multiple tooth restorations.<br>The prosthetic restoration can be cemented or<br>directly veneered/screw-retained. | | | Source of<br>Input Files | Intra-Oral Scanner<br>Bench-top Scanners | Intra-Oral Scanner<br>Bench-top Scanners | N/A | N/A | Identical to primary<br>predicate | | Bench<br>Scanner<br>Control | Yes | Yes | N/A | N/A | Identical to primary<br>predicate | | Implant<br>Detection | Yes, using Scanbodies | Yes, using Scanbodies | N/A | N/A | Identical to primary<br>predicate | | FEATURE | SUBJECT DEVICE<br>K203456 | PRIMARY PREDICATE DEVICE<br>K171649 | REFERNCE DEVICE<br>K190082 | REFERENCE DEVICE<br>K190040 | EQUIVALENCE<br>DISCUSSION | | Design<br>Environment | Straumann CARES Visual:<br>Closed CAD System facilitating<br>the design of restorations used in<br>conjunction with the devices of<br>the Straumann Dental Implant<br>System (SDIS). | Straumann CARES Visual:<br>Closed CAD System facilitating<br>the design of restorations used in<br>conjunction with the devices of<br>the Straumann Dental Implant<br>System (SDIS). | N/A | N/A | Identical to primary<br>predicate | | Restoration<br>Types<br>Supported | Device-borne:<br>Copings and crowns for<br>Variobase Abutments<br>Bridges and bars for Variobase<br>for Bridge/Bar Abutments | Device-borne:<br>Copings and crowns for<br>Variobase Abutments<br>Copings, crowns, and bridges for<br>Screw-Retained Abutments<br>Bridges and bars for Variobase<br>for Bridge/Bar Abutments<br>Solid TAN Abutments for<br>Straumann Implants | Device-borne:<br>Copings and crowns for<br>Variobase Abutments | Device-borne:<br>Bridges and bars for Variobase for Bridge/Bar<br>Abutments | Included in primary<br>predicate<br>Identical to<br>reference devices | | Compatible<br>Implants | Straumann Bone Level implants<br>having the WB, RB/WB implant-<br>to-abutment interface geometries. | Straumann Bone Level implants<br>having the NC and RC implant-<br>to-abutment interface geometries.<br>Straumann Tissue Level implants<br>having the NNC, RN, and WN<br>implant-to-abutment interface<br>geometries. | Straumann Bone Level implants<br>having the WB, RB/WB implant-<br>to-abutment interface geometries. | Straumann Bone Level implants having the WB,<br>RB/WB implant-to-abutment interface<br>geometries. | Identical to<br>reference devices | | Abutment<br>Platform<br>Diameters | 3.8 – 5.5 mm | 3.8 – 7.0 mm | 3.8 – 5.5 mm…