Abutment Design

{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 text "U.S. Food & Drug Administration" in blue. October 7, 2020 3Shape A/S Jenny Axel Regulatory Affairs Specialist Holmens Kanal 7 Copenhagen 1060 DENMARK Re: K200100 Trade/Device Name: Abutment Design Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: PNP Dated: July 13, 2020 Received: July 15, 2020 # Dear Jenny Axel: 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, for Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K200100 Device Name Abutment Design #### Indications for Use (Describe) Abutment Design is intended as an aid to the restoration in partially or fully edentulous mandibles and maxillae. Abutment Design is intended for use by a dental practitioner or dental laboratory staff for designing the patient specific component of a two-piece, or hybrid dental implant abutment. The resulting abutment design is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|-----------------------------------------| | Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 20px;">☑</span> | | Over-The-Counter Use (21 CFR 801 Subpart C) | <span style="font-size: 20px;">☐</span> | #### 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}------------------------------------------------ # 35 # 510(K) SUMMARY K200100 #### Submitter Information | Company Name: | 3Shape A/S | |--------------------------------|---------------------------------------------| | Company Address: | Holmens Kanal 7<br>DK-1060 Copenhagen K | | Company Phone:<br>Company Fax: | +45 7027 2620<br>+45 7027 2621 | | Contact Person: | Jenny Axel<br>Regulatory Affairs Specialist | | Date Summary Prepared: | October 7, 2020 | ## Device Identification | 510(k) number: | K200100 | |-------------------------|------------------------------------| | Trade/proprietary Name: | Abutment Design | | Regulation Number: | 872.3630 | | Classification: | Class 2 | | Product Code: | PNP | | Regulation Name: | Endosseous dental implant abutment | #### Primary Predicate Device The primary predicate device is 3Shape Abutment Designer™ (K151455) manufactured by 3Shape A/S. The Abutment Design software for abutments (K200100), based on the information and supporting documentation provided, has the same intended use, scientific concept, and technical characteristics as the primary predicate device (K151455). Both software devices are used by dental professionals for the design of endosseous dental implant abutments, and the devices ensure only FDA cleared abutment systems can be used. Therefore, the Abutment Design software (K200100) and the predicate (K151455) are found to be similar in their intended use, supported anatomic areas and the available relevant features and functionalities. {4}------------------------------------------------ ## Indications for Use Abutment Design is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. Abutment Design is intended for use by a dental practitioner or dental laboratory staff for designing the patient specific component of a two-piece, one-piece, or hybrid dental implant abutment. The resulting abutment design is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device. #### Device Description The Abutment Design software receives scan data containing topographical characteristics of real teeth, dental impressions, or stone models. The software provides the user with the ability to create matching endosseous dental implant abutments using computer aided design. The Abutment Design is restricted to be used with 510(k) cleared abutment systems, and the design output from Abutment Design (the patient specific part of the abutment) must be manufactured according to the instruction of the selected abutment system. The Abutment Design software includes design parameters from the 510(k) cleared abutment systems such as implant type, maximum and minimum dimensions (e.g., abutment post height, gingival height, angulation, gingival margin diameter, etc.). The design parameters, provided by abutment system manufacturers, for an abutment system are available via a 3Shape server when documentation of the 510(k) clearance of said implant system is presented to 3Shape. Abutment Design has no patient contact being a software only device. # Scientific Concept The underlying scientific concept of the Abutment Design software is to apply digital imaging tools for computer aided design, CAD, of abutments. The system supports the following types of digital data: DCM and STL #### Summary of the technological characteristics Abutment Design™ is a software only device programmed in C# and Delphi and has the following PC/laptop hardware requirements equivalent to the reference device: | Item | Minimum Requirements<br>Abutment Design (K200100) | Minimum Requirements<br>3Shape Abutment Designer™<br>(K151455) | |-------------------------|-------------------------------------------------------------------------------------|----------------------------------------------------------------| | OS: | Windows 7, 8, 8.1 or 10 (64-bit) | Windows 7 32-bit Professional* | | RAM: | 8 GB | 4 GB | | Monitor<br>Resolution: | 1920x1080 pixels | 1440x900 pixels | | Video Card<br>Memory: | 1GB DirectX 11 | 512MB DirectX 10<br>(1GB DirectX 10) | | Available<br>HDD Space: | 500 GB (1TB if used as a standalone<br>system or a server with the order<br>folder) | 250 GB | {5}------------------------------------------------ | CPU: | Intel Core i7 or equivalent | Intel Core i5 or equivalent | |------------|--------------------------------------------|--------------------------------------------| | Network: | Network Internet connection | Internet connection | | USB ports: | USB 2.0 port for 3Shape desktop<br>scanner | USB 2.0 port for 3Shape desktop<br>scanner | | Mouse: | With the wheel button support | Mouse with wheel button support | | 3D Mouse: | (Optional) 3DConnexion<br>SpaceMouse™ Pro | (Recommended)3DConnexion<br>SpaceMouse™ | The Abutment Design software has the same intended uses and technical characteristics as the Abutment Designer™ software (K151455) also manufactured by 3Shape A/S: | Feature name | Abutment<br>Design<br>K200100 | Abutment<br>Designer ™<br>K151455 | Identical to<br>Predicate | |--------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------| | 1. Graphical UI | Yes | Yes | Yes | | 2. Windows OS platform | Yes | Yes | Yes | | 3. Uses standard PC<br>hardware | Yes | Yes | Yes | | 4. Digitally imports<br>topography of teeth by 3D<br>Scan | Yes | Yes | Yes | | 5. Uses 3D CAD design<br>tools | Yes | Yes | Yes | | 6. Patient specific<br>abutment design | Yes | Yes | Yes | | 7. Implant Bar design | No | Yes | No, outside<br>indications for use | | 8. Export to remote milling<br>machine by internet | Yes | Yes | No, the subject<br>device workflow<br>requires<br>instructed user<br>actions | | 9. Network Protocol | Internet/TCP-IP | Internet/TCP-IP | Yes | | 10. Intended users | Dental<br>practitioners<br>and dental<br>technicians | Dental<br>practitioners<br>and dental<br>technicians | Yes | | 11. Output type | Digital<br>encrypted or<br>non-encrypted | Digital<br>encrypted or<br>non-encrypted | Yes | | | | | | | | proprietary or<br>.STL file only of<br>the patient-<br>specific<br>abutment<br>component, not<br>including the<br>abutment-to-<br>implant<br>connection<br>interface.<br><br>If encryption is<br>active or not<br>will solely be<br>determined by<br>the 510(k)<br>clearance of the<br>abutment<br>system. | proprietary<br>or .STL file only<br>of the patient-<br>specific<br>abutment<br>component, not<br>including the<br>abutment-to-<br>implant<br>connection<br>interface.<br><br>If encryption is<br>active or not will<br>solely be<br>determined by<br>the 510(k)<br>clearance of the<br>abutment<br>system. | | | 12. Device submission<br>includes pre-manufactured<br>prosthetics* | No | No | Yes | {6}------------------------------------------------ * Endosseous dental implant abutments as per 21CFR872.3630 # Nonclinical Testing Software, hardware, and integration verification and validation testing was performed in accordance with the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", issued on May 11, 2005. The validation suite includes validation of implemented mitigations related to device hazards identified in the risk management procedures. The cybersecurity analysis was performed in accordance with the FDA Guidance Document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", issued on October 02, 2014. All test results have been reviewed and approved, showing the Abutment Design™ to be substantially equivalent to the primary predicate device. ## Clinical Testing Clinical testing is not a requirement and has not been performed. #### Conclusion {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for 3Shape. The text "3shape" is written in a sans-serif font, with the "3" being slightly separated from the rest of the word. To the right of the word is a red triangle pointing to the right, with a smaller triangle cut out of the center. Based on a comparison of intended use, indications, scientific concept, features and technical data, and test results, the Abutment Design software is found to be as safe and effective as the primary predicate device. Therefore, Abutment Design is found to be substantially equivalent with the primary predicate device.