(595 days)
Not Found
No
The summary describes a software application for designing dental restorations based on scan data, without mentioning any AI or ML capabilities. The performance metrics and validation focus on dimensional and angular accuracy, typical of CAD software, not AI/ML performance metrics.
No
The device is a software for designing dental restorations, not a device that directly treats a condition or provides therapy.
No
The device is a software for aid in design and manufacture of patient-specific dental prosthetics, which is not a diagnostic function.
Yes
The device is described as a "software device" and a "software application" that runs on "off-the-shelf" PC hardware. Its function is solely for the design of dental restorations, and the output is intended for use by a manufacturer to create the final physical device. The summary focuses on software verification and validation, not hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the software is for the design of patient-specific implant-borne prosthetics. It is an aid to restoration and the design result is used by a manufacturer to create the final device.
- Device Description: The device is described as a software application for designing dental restorations.
- Lack of Biological Sample Analysis: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This software does not analyze any biological samples. Its input is scan data of teeth, impressions, or models, which are physical representations, not biological specimens.
The device is a medical device, specifically a software medical device used in the design and manufacturing process of dental prosthetics. However, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The AbutmentCAD module is intended as an aid to the restoration in partially or fully edentulous mandibles and maxillae. AbutmentCAD is a software device intended to be used by trained professionals in dental practices or dental laboratories for the design of patient specific implant borne prosthetics such as one-piece abutments, two-piece/hybrid abutments, single or multi-unit screw-retained restorations. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.
Product codes
PNP
Device Description
AbutmentCAD is a software application for the purpose of designing patient-specific implant-based dental restorations, such as one-piece abutments, two-piece/hybrid abutments and single or multi-unit screw retained restorations. The AbutmentCAD software can be used with basic dental CAD systems such as exocad's ChairsideCAD. AbutmentCAD is used solely for the patient-specific components of abutments and screw retained crowns and bridges. The software application runs on "off-the-shelf" PC hardware with current Microsoft Windows operating system and standard peripheral components. A restoration is designed based on the imported scan and the geometry information of objects in integrated implant libraries based on data of original implant manufacturers. These libraries contain data of connection geometries to implants and so called "design limitations" (also referred to as "design constraints" in other devices) in order to adhere to specific instructions of implant manufacturers of 510(k) cleared implants/abutments. The respective connection geometry cannot be changed in the design process. The usage of these libraries allows to design high precision, implant-based restorations for the following design options: Abutments, one-piece, two-piece/hybrid. Bridges, screw retained (multi-unit crown), Crowns, screw retained, Bars, screw retained. During the design of one of the above reconstructions, design limitations (e.g. angulation, height, etc.) stored in the Implant Libraries are verified so that items with design parameters beyond the defined limitations cannot be created with the AbutmentCAD software application. These limitations correspond to the specific instructions of the holder of an implant abutment 510(k). The final design geometry along with information on the required material is transferred to a compatible milling system for manufacturing. Furthermore, with the information of a selected target milling machine for manufacturing of the part under design, additional information of specific capabilities of the machine are adhered to by AbutmentCAD directly at the stage of design to ensure that the part can be manufactured.
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
trained professionals in dental practices or dental laboratories
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)
Software verification and validation is performed in accordance with the applicable guidance document, ("Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11, 2005). Prior to release of AbutmentCAD the verification and validation of the device has been completed. Each user requirement and each product requirement derived thereof has an own acceptance criteria. A cybersecurity analysis was performed in accordance with the FDA Guidance Document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", issued on 2014-10-02. exocad monitors vulnerabilities of the products and components during lifetime and analyses them in a post-marketcybersecurity process that involves also risk management. Detected anomalies are evaluated and either resolved or in case of a minor issue described in the release notes. The testing includes a validation with end-users of the product. Feedback of software testers and feedback from validation is regarded in the device as appropriate. The described approach for testing also includes testing of cybersecurity requirements determined in the cybersecurity analysis. During software verification we ensure that the design limitations are correctly triggered with an accuracy of 0.01mm for dimensional constraints and an accuracy of 0.5° for angular constraints. For verification realistic and artificial data and a 3ª party tools are used to proof the correctness of our software with respect of the design limitations. In order to generate an abutment design library, exocad developed a software tool which is part of, and used in conjunction with AbutmentCAD. It is made available to the holder of an abutment 510(k) to support the creation abutment libraries which include specific design parameters of abutments. Use of this tool is mandatory for creating abutment libraries and ensures abutment design parameters are enforced through the design process. The software tool and its output have been validated as part of this premarket notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it.
exocad GmbH Stefan Walter Quality Manager 37 Julius-Reiber-Str. Darmstadt, HE 64293 GERMANY
Re: K193352
Trade/Device Name: AbutmentCAD Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: PNP Dated: June 13, 2021 Received: June 21, 2021
Dear Stefan Walter:
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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193352
Device Name
AbutmentCAD
Indications for Use (Describe)
The AbutmentCAD module is intended as an aid to the restoration in partially or fully edentulous mandibles and maxillae. AbutmentCAD is a software device intended to be used by trained professionals in dental practices or dental laboratories for the design of patient specific implant borne prosthetics such as one-piece abutments, two-piece/hybrid abutments, single or multi-unit screw-retained restorations. The design result 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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3
K193352 510(k) Summary
Submitter Information
exocad GmbH 37 Julius-Reiber-Strasse Darmstadt, HE 64293 Germany Contact Person: Stefan Walter, Quality Manager Phone: +49-6151-629489-0
Establishment Registration number: 3011521456
Date prepared: 2021-07-21
Manufacturing Facility
Same as submitter.
Device Information
Trade/proprietary Name: Device Classification Name: Regulation Number: Classification: Classification Product Code: AbutmentCAD Dental Abutment Design Software for Dental Laboratory 872.3630 Class II PNP
Predicate Device
AbutmentCAD has been compared to the following predicate legally marketed device:
| 510(k) Number: | K151455 |
|---|---|
| Predicate device: | 3Shape Abutment Designer |
| Manufacturer: | 3Shape A/S, Holmens Kanal 7, DK-1060 Copenhagen K |
Indications for Use
The AbutmentCAD module is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. AbutmentCAD is a software device intended to be used by trained professionals in dental practices or dental laboratories for the design of patient specific implant borne prosthetics such as one-piece abutments, two-piece/hybrid abutments, single or multi-unit screw-retained restorations. The design result is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.
4
Device Description & Summary of Technical Characteristics
AbutmentCAD is a software application for the purpose of designing patient-specific implant-based dental restorations, such as one-piece abutments, two-piece/hybrid abutments and single or multi-unit screw retained restorations. The AbutmentCAD software can be used with basic dental CAD systems such as exocad's ChairsideCAD. AbutmentCAD is used solely for the patient-specific components of abutments and screw retained crowns and bridges.
The software application runs on "off-the-shelf" PC hardware with current Microsoft Windows operating system and standard peripheral components.
Design - Abutments
A restoration is designed based on the imported scan and the geometry information of objects in integrated implant libraries based on data of original implant manufacturers. These libraries contain data of connection geometries to implants and so called "design limitations" (also referred to as "design constraints" in other devices) in order to adhere to specific instructions of implant manufacturers of 510(k) cleared implants/abutments. For more details see next section.
The respective connection geometry cannot be changed in the design process. The usage of these libraries allows to design high precision, implant-based restorations for the following design options:
- Abutments, one-piece, two-piece/hybrid
- . Bridges, screw retained (multi-unit crown)
- Crowns, screw retained
- Bars, screw retained
During the design of one of the above reconstructions, design limitations (e.g. angulation, height, etc.) stored in the Implant Libraries are verified so that items with design parameters beyond the defined limitations cannot be created with the AbutmentCAD software application. These limitations correspond to the specific instructions of the holder of an implant abutment 510(k).
The final design geometry along with information on the required material is transferred to a compatible milling system for manufacturing. Furthermore, with the information of a selected target milling machine for manufacturing of the part under design, additional information of specific capabilities of the machine are adhered to by AbutmentCAD directly at the stage of design to ensure that the part can be manufactured.
Manufacturing (not in the scope of the device under evaluation)
Restorations designed with AbutmentCAD may only be manufactured by holders of an implant abutment 510(k) or milled according to the specific instructions provided by the holder of a 510(k)-clearance for a patientspecific implant abutment.
5
Implant Libraries
AbutmentCAD uses so called abutment libraries that are based on detailed information, sizes, catalogue numbers, 3D meshes and information about design limitations (see below) of implants. All information is provided by the original manufacturer of a respective physical part and is integrated by exocad into a library. Implant libraries may contain, e.g. implants, a titanium bases and similar related parts.
AbutmentCAD loads the library parts during the design process. The connection geometry defined by the implant manufacturer cannot be modified at any time. The implant libraries allow to define so called design limitations such as maximum height or maximum anqulation for the design of an abutment.
With the information of design limitations of the parts (e.g. the angulation or maximum height) contained in the implant libraries it is possible to control the design process and ensure that the design results conform to implant specific instructions of the implant manufacturer.
The libraries are digitally signed and by that any modification of a library content or the referred library parts or files is detected by AbutmentCAD and it is not possible to use the library.
Information contained in a library is:
- Data of interface parts, such as titanium bases, compatible to a specific implant, and interface . geometry to the tooth reconstruction
- Data not used for the design, which serves merely for graphical representation during the design ● process (e.g. screw threads, implant analogs, pre-mill holders, and other meta information)
- . Data defining the minimum thickness geometry as a lower limit to the design of implant-based restorations.
- Scan abutment data that allows recognition of the implant position within optical scan data
- Data of design limitations, as required by holder of an implant abutment 510(k), for implant-based tooth reconstructions, such as maximum and minimum dimensional parameters.
- Connection geometry and screw channel geometry, permitting a design of reconstruction with an interface, e.g. titanium base and direct-to-implant tooth reconstruction (e.g. single piece abutments/screw-retained crowns and bridges).
Design Limitations
The following design limitations are adhered to for the design of abutments:
- minimum wall thickness .
- . minimum and maximum height of the emergence profile
- minimum and maximum diameter of the emergence profile ●
- minimum and maximum height of the entire abutment ●
- minimum and maximum height of the abutment above the emergence profile ●
- minimum and maximum anqulation of the abutment above the emergence profile in relation to the ● implant axis
- minimum and maximum angulation of the screw channel in relation to the axis of the abutment above the emergence profile
- minimum and maximum angulation of the screw channel in relation to the implant axis ●
- size limitation of the abutment due to the size of the pre-milled abutment blank ●
- restriction to specific tooth numbers (e.g. narrow implants are typically intended to be used for ● anterior teeth)
The following design limitations are adhered to for the design of screw retained bridges:
- overall length of a bridge
- . length of a bridge arc between two implants
- length of a bridge extension .
- length of a single unit implant-based bridge with bridge extension ●
- size requirements for the manufacturing of the bridge (size of the intended blank or stock material versus size of the bridge under design)
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Non-clinical Testing
Software verification and validation is performed in accordance with the applicable guidance document, ("Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11, 2005). Prior to release of AbutmentCAD the verification and validation of the device has been completed. Each user requirement and each product requirement derived thereof has an own acceptance criteria.
A cybersecurity analysis was performed in accordance with the FDA Guidance Document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices", issued on 2014-10-02. exocad monitors vulnerabilities of the products and components during lifetime and analyses them in a post-marketcybersecurity process that involves also risk management.
Detected anomalies are evaluated and either resolved or in case of a minor issue described in the release notes. The testing includes a validation with end-users of the product. Feedback of software testers and feedback from validation is regarded in the device as appropriate.
The described approach for testing also includes testing of cybersecurity requirements determined in the cybersecurity analysis.
During software verification we ensure that the design limitations are correctly triggered with an accuracy of 0.01mm for dimensional constraints and an accuracy of 0.5° for angular constraints. For verification realistic and artificial data and a 3ª party tools are used to proof the correctness of our software with respect of the design limitations.
In order to generate an abutment design library, exocad developed a software tool which is part of, and used in conjunction with AbutmentCAD. It is made available to the holder of an abutment 510(k) to support the creation abutment libraries which include specific design parameters of abutments. Use of this tool is mandatory for creating abutment libraries and ensures abutment design parameters are enforced through the design process. The software tool and its output have been validated as part of this premarket notification.
7
Comparative information on Predicate Device
Abutment CAD has been compared to the following predicate legally marketed device: 510(k) Number: K151455 3Shape Abutment Designer Predicate device:
The following tables provides a comparison of the predicate device with AbutmentCAD.
| Comparable
Criteria | Predicate device | Device under evaluation | Evalu-
ation |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| Trade/ proprietary
Name, 510(k) #: | 3Shape Abutment Designer, K151455 | AbutmentCAD 2.3 | --- |
| Device
Classification: | Dental Abutment Design Software For Dental
Laboratory | Dental Abutment Design Software For Dental
Laboratory | Substantially
equivalent |
| Regulation Number: | 872.3630 | | Substantially
equivalent |
| Classification: | Class II | Class II | Substantially
equivalent |
| Product Code: | PNP | PNP | Substantially
equivalent |
| Prescription/ over
the counter use | Prescription use | Prescription use | Substantially
equivalent |
| 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 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 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. | The AbutmentCAD module is intended as an aid
to the restoration of chewing function in partially
or fully edentulous mandibles and maxillae.
AbutmentCAD is a software device intended to
be used by trained professionals in dental
practices or dental laboratories for the design of
patient specific implant borne prosthetics such
as one-piece abutments, two-piece/hybrid
abutments, single or multi-unit screw-retained
restorations. The design result is intended to be
used by the manufacturer of an endosseous
dental implant abutment to create the final
device. | Substantially
equivalent |
| - used as | 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 AbutmentCAD module is intended as an aid
to the restoration of chewing function in partially
or fully edentulous mandibles and maxillae. | Substantially
equivalent |
| - used by | "… intended for use by a dental practitioner or dental
laboratory staff …" | "… intended to be used by trained professionals
in dental practices or dental laboratories …" | Substantially
equivalent |
| - used for | "… for designing the patient specific component of a
two-piece, one-piece or hybrid dental implant
abutment …" | "… for the design of patient specific implant
borne prosthetics such as one-piece abutments,
two-piece/hybrid abutments, single or multi-unit
screw-retained restorations …" | Substantially
equivalent |
| - result used by | "… design is intended to be used by the manufacturer
of an endosseous dental implant abutment to create
the final device." | "… design result is intended to be used by the
manufacturer of an endosseous dental implant
abutment to create the final device." | Substantially
equivalent |
| Input data | scan data containing topographical characteristics of
real teeth, dental impressions, or stone models | scan data containing topographical
characteristics of real teeth, dental impressions,
or stone models | Substantially
equivalent |
| Design options | endosseous dental implant abutments; as per specific
instructions of the implant manufacturer | endosseous dental implant abutments; specific
instructions of the implant manufacturer are
adhered to during the design process | Substantially
equivalent |
| Libraries | FDA clearance of the Implant Library. | FDA clearance of the Implant Library, validation
by abutment 510(k) holder, cannot be modified
by end-user. | Substantially
equivalent |
| Output data | Digital encrypted or non-encrypted proprietary or .STL
file including only the patient-specific abutment
component for one-piece, two-piece, or hybrid
abutment designs. | Digital encrypted or non-encrypted proprietary or
.STL file including only the patient-specific
abutment component for one-piece, two-piece,
or hybrid abutment designs. Encryption status of
the library will be determined solely by the 510(k) | Substantially
equivalent |
| | | | |
| | | clearance of the abutment system. | |
| Physical output | N/A - Submission device relies on separate regulatory
clearance and manufacture of the abutment by a
separate company | N/A - Submission device relies on separate
regulatory clearance and manufacture of the
abutment by a separate company | Substantially
equivalent |
| Milling location | Abutment Manufacturer or Dental laboratory per the
510(k) clearance of the dental abutment | Abutment Manufacturer or Dental laboratory per
the 510(k) clearance of the dental abutment | Substantially
equivalent |
| Hardware | Compatible of-the-shelf PC | Any compatible of-the shelf PC, Monitor and
network connection | Substantially
equivalent |
| GUI OS | Windows 7 32-bit or 64-bit Professional | Windows ® 7, 8.1, 10; 64-bit Operating System | Substantially
equivalent,
Up-to-date
OS used |
© 2021 exocad – AbutmentCAD 510(k) Summary, revision 2021-07-21, 006_AbutmentCAD_510k_Summary.docx
8
AbutmentCAD has been compared to a legally marketed predicate device (3Shape Abutment Designer Software, K151455) as documented above. The conclusion is that, based on the comparison of intended use and various characteristics, AbutmentCAD is substantially equivalent to the predicate device.