3Shape Abutment Designer Software
Device Facts
| Record ID | K151455 |
|---|---|
| Device Name | 3Shape Abutment Designer Software |
| Applicant | 3Shape A/S |
| Product Code | PNP · Dental |
| Decision Date | Sep 6, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3630 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Indications for Use
The 3Shape Abutment Designer Software is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. The 3Shape Abutment Designer 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 single or multi-unit abutment design is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.
Device Story
Software-only CAD tool for dental laboratories/practitioners; inputs scan data (topographical characteristics of teeth, impressions, or stone models); utilizes loaded implant libraries (implant type, dimensional parameters) to design patient-specific abutment components; outputs digital files (.STL or proprietary) for manufacturing by authorized 510(k) holders; operates on standard Windows PC hardware; aids in restoration of chewing function; does not produce physical parts; relies on separate regulatory clearance for the physical implant abutment.
Clinical Evidence
Bench testing only. Verification and validation performed per FDA software guidance; includes user need validation, specification verification, bug tracking, and beta partner testing. No clinical data presented.
Technological Characteristics
Software-only device; programmed in Delphi; runs on Windows PC (min 4GB RAM, DirectX 10 video card, 250GB HDD); requires internet connection for implant library acquisition; standalone deployment; no physical patient-contacting parts.
Indications for Use
Indicated for partially or fully edentulous patients requiring dental implant abutment restoration. Intended for use by dental practitioners or laboratory staff to design patient-specific components for two-piece, one-piece, or hybrid dental implant abutments.
Regulatory Classification
Identification
An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
Special Controls
*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
Predicate Devices
- Sirona Dental CAD/CAM System (K100152)
Reference Devices
- Camlog Implant System (K083496)
- Nobel Biocare Replace (K020646)
- Nobel Biocare Branemark (K022562)
- Friadent Xive (K013867)
- Biomet 3i Osseotite (K980549)
- Astra Tech Osseospeed (K091239)
- Zimmer Tapered Screw-Vent (K061410)
- Straumann SynOcta (K061176)
Submission Summary (Full Text)
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 6, 2016
3Shape A/S Hanne Nielsen Regulatory Affairs Manager Holmens Kanal 7 Copenhagen, 1060 DENMARK
Re: K151455
Trade/Device Name: 3Shape Abutment Designer™ Software Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: PNP Dated: January 8, 2016 Received: January 11, 2016
Dear Hanne Nielsen:
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. 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.
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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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# Indications for Use
510(k) Number (if known) K151455
Device Name
3Shape Abutment Designer™ Software
The 3Shape Abutment Designer Software is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. The 3Shape Abutment Designer 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 single or multi-unit 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) | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| <div> <span> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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# 510(K) SUMMARY - Traditional 510(K)
# Submitter Information
| | A Company Name: | 3Shape A/S | | | |
|-----------------------|----------------------------------|---------------------------------------------------|--|--|--|
| | B Company Address: | Holmens Kanal 7<br>DK-1060 Copenhagen K | | | |
| | C Company Phone:<br>Company Fax: | +45 7027 2620<br>+45 7027 2621 | | | |
| | D Contact Person: | Hanne Nielsen<br>Regulatory Affairs Manager | | | |
| | E Date Summary Prepared: | June 28, 2016 | | | |
| Device Identification | | | | | |
| | A Trade/proprietary Name: | 3Shape Abutment Designer™<br>Software | | | |
| | B Common Name: | Abutment design software for dental<br>laboratory | | | |
| | C Device Classification Name: | Endosseous Dental Implant Abutment | | | |
| | C Requlation Number: | 872.3630 | | | |
| | C Classification: | Class II | | | |
| | D Product Code: | PNP | | | |
### Predicate Device
Sirona Dental CAD/CAM System (K100152).
### Intended Use
The 3Shape Abutment Designer Software is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. The 3Shape Abutment Designer Software 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
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implant abutment. The single or multi-unit abutment design is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.
#### Device Description
The 3Shape Abutment Designer™ 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 output of the device is a computer file containing the abutment(s) in digital form which can be used by manufacturers that hold an implant abutment 510(k) or are milling per the specific instructions provided by the holder of a 510(k) marketing clearance for a patient specific implant abutment. The 3Shape Abutment Designer Software output is restricted in the U.S. to be manufactured by a holder of an implant abutment 510(k) or milled per the specific instructions provided by the holder of a 510(k) marketing clearance for a patient specific implant abutment.
The 3Shape Abutment Designer™ Software can be run on properly configured "off-the-shelf" PC hardware running Microsoft® Windows and using a standard keyboard and mouse.
The 3Shape Abutment Designer™ Software requires the loading of implant libraries, which includes information such as implant type, maximum and minimum dimensional parameters for abutments, etc., created by separate abutment manufacturers and cleared by the FDA. In the US, the Implant Libraries are obtained via a 3Shape server after demonstration to 3Shape of the FDA clearance of the Implant Library.
### Summary of the technological characteristics
The 3Shape Abutment Designer™ is a software only device programmed in the Delphi programming language and has the following PC/laptop requirements and other technological characteristics as compared to the predicate device:
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| Item | Submission<br>Device Minimum<br>Requirements | Submission<br>Device<br>Recommended | Predicate Device |
|------------------------|----------------------------------------------|---------------------------------------|-------------------------------------------|
| OS | Windows 7 32-bit<br>Professional* | Windows 7 64-bit<br>Professional | Windows Vista 32- bit |
| RAM | 4GB | 8GB (16GB) | 6GB |
| Video Card | 512MB DirectX<br>10 (1GB DirectX<br>10) | 1GB DirectX 11<br>(2GB DirectX<br>11) | 512 MB DirectX 10<br>NVIDIA Quadro |
| Available<br>HDD Space | 250GB | 500GB (1TB) | 500GB |
| CPU | Intel Core i5<br>or equivalent | Intel Core i7<br>or equivalent | Intel Core i7 |
| Monitor<br>resolution | 1440 x 900 pixels | 1920 x 1080<br>pixels | Unknown |
| 3D Mouse | None | 3DConnexion<br>SpaceMouse™ | Unknown |
| Network | Internet connection | | Unknown |
| Ports | USB 2.0 port for 3Shape<br>desktop scanner | | Serial Port PCI card for inEOS<br>scanner |
| Mouse | Mouse with wheel button support | | Unknown |
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| Indications<br>for Use | The 3Shape Abutment Designer Software is<br>intended as an aid in the restoration of<br>chewing function in partially or fully<br>edentulous mandibles and maxillae. The<br>3Shape Abutment Designer Software is<br>intended for use by a dental practitioner or<br>dental laboratory staff for designing the<br>patient specific component of a two-piece,<br>one-piece or hybrid dental implant<br>abutment. The single or multi-unit<br>abutment design is intended to be used by<br>the manufacturer of an endosseous dental<br>implant abutment to create the final device. | The Sirona Dental CAD/CAM System<br>is intended for use in partially or fully<br>edentulous mandibles and maxillae in<br>support of single or multi-unti cement<br>retained restorations. The system<br>consists of three major parts:<br>TiBase, InCoris mesostructure, and<br>CAD/CAM software. Specifically, the<br>InCoris mesostructure and TiBase<br>components make up a two-piece<br>abutment which is used in<br>conjunction with endosseous dental<br>implants to restore the function and<br>asesthetics in the oral cavity. The<br>InCoris mesostructure may also be<br>used in conjunction with the CAMlog<br>Titanium base CAD/CAM (types<br>K2244.xxxx) (K083496) in the<br>Camlog Implant System. The<br>CAD/CAM software is intended to<br>design and fabricate the InCoris<br>mesostructure. The InCoris<br>mesostructure and TiBase two-piece<br>abutment is compatible with the<br>following implant systems: Nobel<br>Biocare Replace (K020646), Nobel<br>Biocare Branemark (K022562),<br>Friadent Xive (K013867), Biomet 3i<br>Osseotite (K980549), Astra Tech<br>Osseospeed (K091239), Zimmer<br>Tapered Screw-Vent (K061410), and<br>Straumann SynOcta (K061176). |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Software<br>Output | Digital encrypted or non-encrypted<br>proprietary or .STL file including only the<br>patient-specific abutment component for<br>one-piece, two-piece, or hybrid abutment<br>designs. The digital output does not include<br>the abutment-to-implant connection<br>interface. | .STL file of the ceramic mesostrucutre<br>sent to Sirona Dental CAD/CAM<br>System milling unit |
| Physical -<br>Output | N/A – Submission device relies on separate<br>regulatory clearance and manufacture of the<br>abutment by a separate company | Two-piece Tibase abutment - pre-<br>milled titanium base combined with<br>ceramic mesostructure designed in<br>Sirona CAD/CAM software. |
| Milling<br>Location | Abutment Manufacturer or Dental laboratory<br>per the 510(k) clearance of the dental<br>abutment | Local milling of the ceramic abutment<br>component. |
The predicate Sirona device includes in the marketing clearance the twopiece TiBase Abutments (titanium bases and ceramic blocks) as a physical output as well as a validated milling unit and directions for assembly of the final dental abutment. The 3Shape Abutment Designer™ Software does not provide any physical parts that can come into contact with the patient. The 3Shape Abutment Designer Software instead provides only the digital design as an accessory to the physical dental abutment systems cleared by other manufacturers. The differences between the Indications for Use
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Statement of the submission device and the predicate are related to the lack of physical output from the submission device and reliance on previous or subsequent FDA clearance of the physical abutment by a separate manufacturer. However, the difference does not change the intended use of the device.
#### 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) as well as the FDA Guidance Document "Off-The-Shelf Software Use in Medical Devices (Issued on September 9, 1999).
Prior to release, verification and validation testing of the 3Shape Abutment Designer™ Software has been completed using the approved acceptance criteria: Each user need has its own validation acceptance criteria; each specification has its own verification acceptance criteria; bug verification consists in ensuring issue is not reproducible; issues reported by beta partners must be reviewed and handled appropriately; beta partners must report functionality to be an improvement over previous version.
The validation suite includes validation of implemented mitigations related to device hazards identified in the risk management procedures.
#### Conclusion
Based on a comparison of intended use, principle of operations, features and technical data, and the verification/validation test results, the 3Shape Abutment Designer™ Software is found to be substantially equivalent with the Predicate Device.
