(265 days)
Not Found
No
The description focuses on computer-aided design (CAD) tools and the use of pre-defined parameters from cleared abutment systems, with no mention of AI or ML techniques for design generation or analysis.
No
This device is a software for designing dental implant abutments, not the abutment itself, and therefore does not directly provide therapy. It is an aid to restoration design.
No
The device is described as software for designing patient-specific dental implant abutments, and its intended use is to aid in restoration. It does not perform any diagnostic function such as identifying, detecting, or assessing a medical condition or disease.
Yes
The device description explicitly states "Abutment Design has no patient contact being a software only device."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Abutment Design software is used to design a patient-specific component of a dental implant abutment based on scan data of teeth, impressions, or models. It is a design tool for a medical device that will be implanted in the body.
- No Biological Samples: The software does not process or analyze any biological samples from the patient. Its input is topographical data.
- Intended Use: The intended use is to aid in the restoration of the mandible and maxillae by designing a component of a dental implant, not to diagnose a disease or condition.
Therefore, the Abutment Design software falls under the category of a medical device, specifically a software medical device used in the design and manufacturing process of a dental implant component, but it is not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
PNP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
scan data containing topographical characteristics of real teeth, dental impressions, or stone models
Anatomical Site
partially or fully edentulous mandibles and maxillae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental practitioner or dental laboratory staff
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
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.(b)
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.)
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) | ☑ |
| Over-The-Counter Use (21 CFR 801 Subpart C) | ☐ |
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35
510(K) SUMMARY K200100
Submitter Information
| Company Name: | 3Shape A/S |
|---|---|
| Company Address: | Holmens Kanal 7 |
| DK-1060 Copenhagen K | |
| Company Phone: | |
| Company Fax: | +45 7027 2620 |
| +45 7027 2621 | |
| Contact Person: | Jenny Axel |
| 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
Abutment Design (K200100) | Minimum Requirements
3Shape Abutment Designer™
(K151455) |
|-------------------------|-------------------------------------------------------------------------------------|----------------------------------------------------------------|
| OS: | Windows 7, 8, 8.1 or 10 (64-bit) | Windows 7 32-bit Professional* |
| RAM: | 8 GB | 4 GB |
| Monitor
Resolution: | 1920x1080 pixels | 1440x900 pixels |
| Video Card
Memory: | 1GB DirectX 11 | 512MB DirectX 10
(1GB DirectX 10) |
| Available
HDD Space: | 500 GB (1TB if used as a standalone
system or a server with the order
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 | |
| scanner | USB 2.0 port for 3Shape desktop | |
| scanner | ||
| Mouse: | With the wheel button support | Mouse with wheel button support |
| 3D Mouse: | (Optional) 3DConnexion | |
| SpaceMouse™ Pro | (Recommended)3DConnexion | |
| 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
Design
K200100 | Abutment
Designer ™
K151455 | Identical to
Predicate |
|--------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| 1. Graphical UI | Yes | Yes | Yes |
| 2. Windows OS platform | Yes | Yes | Yes |
| 3. Uses standard PC
hardware | Yes | Yes | Yes |
| 4. Digitally imports
topography of teeth by 3D
Scan | Yes | Yes | Yes |
| 5. Uses 3D CAD design
tools | Yes | Yes | Yes |
| 6. Patient specific
abutment design | Yes | Yes | Yes |
| 7. Implant Bar design | No | Yes | No, outside
indications for use |
| 8. Export to remote milling
machine by internet | Yes | Yes | No, the subject
device workflow
requires
instructed user
actions |
| 9. Network Protocol | Internet/TCP-IP | Internet/TCP-IP | Yes |
| 10. Intended users | Dental
practitioners
and dental
technicians | Dental
practitioners
and dental
technicians | Yes |
| 11. Output type | Digital
encrypted or
non-encrypted | Digital
encrypted or
non-encrypted | Yes |
| | | | |
| | proprietary or
.STL file only of
the patient-
specific
abutment
component, not
including the
abutment-to-
implant
connection
interface.
If encryption is
active or not
will solely be
determined by
the 510(k)
clearance of the
abutment
system. | proprietary
or .STL file only
of the patient-
specific
abutment
component, not
including the
abutment-to-
implant
connection
interface.
If encryption is
active or not will
solely be
determined by
the 510(k)
clearance of the
abutment
system. | |
| 12. Device submission
includes pre-manufactured
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
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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.