(455 days)
K200100 Abutment Design .
No
The summary describes a CAD software that uses predefined design libraries and restrictions, not AI/ML for design generation or analysis. There is no mention of AI, ML, or related concepts in the document.
No
This device is a CAD software used for designing dental prosthetics, not for direct therapeutic interaction with a patient. It assists in the creation of therapeutic devices (implant-borne restorations) but is not a therapeutic device itself.
No
Explanation: The device is CAD software used for designing dental prosthetics (abutments, crowns, bridges) based on scan files, not for diagnosing medical conditions. It functions as a design tool for restorative purposes.
Yes
The device is explicitly described as "dental CAD software" and states it "has no patient contact since it is software." Its output is a "three-dimensional geometry file," which is then used for manufacturing or printing on separate hardware. The description focuses solely on the software's functionality and verification/validation.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Straumann CARES Visual/Nova software is a CAD software used for designing dental prosthetics (abutments, crowns, bridges, bars) based on scan files of the patient's intraoral situation. It does not analyze biological specimens from the patient's body.
- Intended Use: The intended use is for the design of dental restorations, not for diagnostic purposes based on biological samples.
- Input: The input is scan data representing the physical topography of the patient's mouth, not biological specimens.
Therefore, the Straumann CARES Visual/Nova software falls under the category of a medical device used in the design and manufacturing process of dental prosthetics, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Straumann CARES Visual/Nova Implant-borne CAD software are indicated for the design of two-piece or one-piece abutment components for 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 and CAD software. The system is used to design two-piece abutment CAD/CAM milled copings, crown and bridge restorations to be cemented onto Ti-bases, customized one-piece abutments and bridges/bars to be affixed to the endosseous dental implants using a basal screw. The use of the software requires the user to have the necessary training and domain knowledge in the practice of prosthetic design, as well as training in the use of the software.
Product codes (comma separated list FDA assigned to the subject device)
PNP
Device Description
Straumann CARES Visual/Nova is a dental CAD software to create implant-borne restorations. The software employs optical impression files that represent the topographical characteristics of the patient's intraoral situation. The Straumann CARES Visual/Nova software then allows the desired restorations. All implant-borne restorations available in Straumann CARES Visual/Nova software require FDA review and 510(k) clearance. Design specifications ("design envelope"), selectable materials, mouth positions need to be described in these 510(k) submissions. Each restorative solution is defined in a secured design library that provides the CAD software with the design specifications and restrictions for instance, minimum wall thickness, maximum angulation, cementable abutment post height etc. Standard connecting geometries e.g., abutment to implant interface are also defined in the library which cannot be edited by a user. Any dental implantborne restoration can only be created within the 510(k)-cleared design envelope.
The output of the CAD software is a three-dimensional geometry file which is linked to meta data like material and patient identifier.
All designed implant-borne restorations are intended to be:
- sent to Straumann for manufacturing by a validated milling center, or .
- milled on a validated Straumann C series or M series milling machine (only . with the CARES Visual software, K171649 and K203456)
- 3D printed as a temporary crown, or temporary bridge (up to 180 days) using P pro . Crown & Bridge material on a validated Straumann P series printer (only with the CARES Visual software, K203750)
Straumann CARES Visual/Nova has no patient contact since it is software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical impression files from Intra-Oral Scanners or Extra-Oral Scanners
Anatomical Site
edentulous mandibles and maxillae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
user to have the necessary training and domain knowledge in the practice of prosthetic design, as well as training in the use of the software.
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 testing was provided to demonstrate use of the Straumann CARES Visual and Nova Dental CAD software device for controlling the design specifications and material selections for any prospective compatible abutment design library that undergoes separate 510(k) clearance for the resultant abutment devices.
Software verification and validation testing was conducted to demonstrate that the restrictions prevent design of the patient-matched components of the prospective compatible abutment design libraries for the workflow options of customizable two-piece abutments, one-piece abutments, and bridges and bars affixed to the endosseous dental implants from being outside of the allowable design limitations, including representative screenshots under user verification testing. In addition, the software verification and validation testing established that the design limitations and specifications of prospective compatible implantabutment design libraries are locked and cannot be modified by the end user.
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.
K200100 Abutment Design .
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.
K200586 Straumann ® TLX Implant System ., K093113 ETKON ES1, MODEL 019.0001, ETKON VISUAL ., K173968 - Straumann Variobase for Bridge/Bar Cylindrical
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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 26, 2024
Institut Straumann AG % Jennifer Jackson Sr. Dir. Regulatory & Quality, NAM Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K233252
Trade/Device Name: Straumann CARES Visual and Nova Dental CAD Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: PNP Dated: November 27, 2024 Received: November 27, 2024
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
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 -S
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
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Device Name
Straumann CARES Visual and Nova Dental CAD
Indications for Use (Describe)
Straumann CARES Visual/Nova Implant-borne CAD
The Straumann CARES Visual/Nova Implant-borne CAD software are indicated for the design of two-piece or onepiece abutment components for 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 and CAD software. The system is used to design two-piece abutment CAD/CAM milled copings, crown and bridge restorations to be cemented onto Ti-bases, customized onepiece abutments and bridges/bars to be affixed to the endosseous dental implants using a basal screw. The use of the software requires the user to have the necessary training and domain knowledge in the practice of prosthetic design, as well as training in the use of the software.
Type of Use (Select one or both, as applicable) 区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 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."
FORM FDA 3881 (9/23))
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
4
Straumann CARES Visual and Nova Dental CAD
Summary
| 510(k) Summary | |
|---|---|
| Submitter: | Straumann USA, LLC (on behalf of Straumann AG) |
| 60 Minuteman Road | |
| Andover, MA 01810 | |
| Registration No.: 1222315 | |
| Owner/Operator No.: 9005052 | |
| On behalf of: | |
| Institut Straumann AG | |
| Peter Merian-Weg 12 | |
| 4052 Basel, Switzerland | |
| Contact Person: | Jennifer M. Jackson, MS, RAC |
| Sr. Director, Regulatory Affairs and Quality | |
| Phone Number: +1 978 747-2509 | |
| Fax Number: +1 978 747-0023 | |
| Prepared By & | |
| Alternate Contact: | Gordon Dodds |
| Manager Design Control Quality Management | |
| Etkon GmbH | |
| Phone number: +49 89 309075 291 | |
| Date Prepared: | December 18, 2024 |
| Name of the Device | |
| Trade Names: | Straumann CARES Visual and Nova Dental CAD |
| Common Name: | CADCAM Dental Software |
| Classification Name: | Abutment Design Software for Dental Laboratory |
| Regulation Number: | §872.3630. |
| Device Classification: | II |
| Product Code(s): | PNP |
| Classification Panel: | Dental |
| Predicate Device(s) | |
| Primary Predicate: |
5
Straumann CARES Visual and Nova Dental CAD
Summary
- K093113 ETKON ES1, MODEL 019.0001, ETKON VISUAL .
- . K173968 - Straumann Variobase for Bridge/Bar Cylindrical
Device Description
Dental CAD Design Software for Implant-borne Restorations
Straumann CARES Visual/Nova is a dental CAD software to create implant-borne restorations. The software employs optical impression files that represent the topographical characteristics of the patient's intraoral situation. The Straumann CARES Visual/Nova software then allows the desired restorations. All implant-borne restorations available in Straumann CARES Visual/Nova software require FDA review and 510(k) clearance. Design specifications ("design envelope"), selectable materials, mouth positions need to be described in these 510(k) submissions. Each restorative solution is defined in a secured design library that provides the CAD software with the design specifications and restrictions for instance, minimum wall thickness, maximum angulation, cementable abutment post height etc. Standard connecting geometries e.g., abutment to implant interface are also defined in the library which cannot be edited by a user. Any dental implantborne restoration can only be created within the 510(k)-cleared design envelope.
The output of the CAD software is a three-dimensional geometry file which is linked to meta data like material and patient identifier.
All designed implant-borne restorations are intended to be:
- sent to Straumann for manufacturing by a validated milling center, or .
- milled on a validated Straumann C series or M series milling machine (only . with the CARES Visual software, K171649 and K203456)
- 3D printed as a temporary crown, or temporary bridge (up to 180 days) using P pro . Crown & Bridge material on a validated Straumann P series printer (only with the CARES Visual software, K203750)
Straumann CARES Visual/Nova has no patient contact since it is software.
Intended Use
Straumann CARES Visual/Nova Implant-borne CAD
The Straumann CARES Visual/Nova Implant-borne CAD is intended for use as a medical front-end device providing tools for management of models. systematic inspection, acquisition of patient anatomy scans, detailed analysis of data, measurement of device features, control of device
6
Straumann CARES Visual and Nova Dental CAD
Summary
dimensions and virtual appliance design of implant-borne prosthetics. The CARES Visual/Nova Implant-borne CAD uses libraries of implant interfaces (containing implant interface geometries, screw geometries, screw-channel design, scanbody dimensions, design limits) to control the design of the prosthetics.
Indications for Use
Straumann CARES Visual/Nova Implant-borne CAD
The Straumann CARES Visual/Nova Implant-borne CAD software are indicated for the design of two-piece or one-piece abutment components for single or multiple-unit implantborne 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 and CAD software. The system is used to design two-piece abutment CAD/CAM milled copings, crown and bridge restorations to be cemented onto Ti-bases, customized one-piece abutments and bridges/bars to be affixed to the endosseous dental implants using a basal screw. The use of the software requires the user to have the necessary training and domain knowledge in the practice of prosthetic design, as well as training in the use of the software.
Technological Characteristics
The underlying scientific concept of the dental CAD design software for implant-borne restorations is to:
- Apply digital imaging tools for visualization of the patient tooth geometries, implant . position and orientation (captured through scanbodies) and adjacent/opposing teeth.
- Allow selection of restoration type (Ti-base crown, Ti-base bridge, one-piece . abutment, screw-retained bridge/bar).
- . Selection of implant interface type from an implant interface library.
- Design prosthetic geometry, with software-controlled material and prosthetic . dimension limits.
- . Modelling the contact points of the dental restoration with the antagonist teeth.
- Management of patient data. .
- Transmission of designs to Straumann central production or (for CARES Visual only) . production of design on a validated point-of-care milling or 3D-printing system.
7
Straumann CARES Visual and Nova Dental CAD
Summary
The technological characteristics of the subject devices are compared to the primary predicate and reference devices in the following tables:
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE |
|---|---|---|
| K Number | K233252 | K200100 |
| RAM | 16 GB | 8 GB |
| Operating | ||
| System | Windows 10 64-bit | Windows 7,8,8.1 or 10 64-bit |
| Monitor | ||
| Resolution | 1280x800 or similar | 1920x1080 pixels |
| Video Card | ||
| Memory | 1 GB | 1 GB |
| Available | ||
| HDD Space | 500 GB | 500 GB |
| CPU | 3.3 GHz Intel Core i5 or equivalent | Intel Core i7 or equivalent |
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE |
| K Number | K233252 | K200100 |
| Indications for use | Straumann CARES Visual/Nova | |
| Implant-borne CAD | ||
| The Straumann CARES | ||
| Visual/Nova Implant-borne CAD | ||
| are indicated for the design of | ||
| two-piece or one-piece abutment | ||
| components for 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 and CAD software. The | ||
| system is used to design two- | ||
| piece abutment CAD/CAM milled | ||
| copings, crown and bridge | ||
| restorations to be cemented onto | ||
| Ti-bases, customized one-piece | ||
| abutments and bridges/bars to be | ||
| affixed to the endosseous dental | ||
| implants using a basal screw. | ||
| The use of the software requires | ||
| the user to have the necessary | ||
| training and domain knowledge in | ||
| the practice of prosthetic design, | ||
| as well as training in the use of | ||
| the software. | 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. | ||
| Managing patient and | ||
| case base data | Yes | Yes |
| Collection of patient | ||
| geometries | Yes | Yes |
| Alignment of patient | ||
| qeometries | Yes | Yes |
| Measurement of | ||
| anatomy features | Yes | Yes |
| Visualize anatomy | ||
| features | Yes | Yes |
| Surface scan import | ||
| from intra-oral | ||
| scanner | Yes | Yes |
| 3D measurement | ||
| toolbox | Yes | Yes |
| Space and contact | ||
| analysis | Yes | Yes |
| Analysis occlusion | ||
| map | Yes | Yes |
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE DEVICE |
| K Number | K233252 | K200100 |
| Management of | ||
| design limitations | Yes | Yes |
| Prosthetic design & | ||
| export | Yes | Yes |
Table 1 – PC/ Laptop hardware requirements comparison - Implant-borne Prosthetic CAD
Feature Comparison of Dental CAD Design Software for Implant-borne Restorations
8
Straumann CARES Visual and Nova Dental CAD
Summary
9
Straumann CARES Visual and Nova Dental CAD
Summary
Table 2 – Comparison of subject and reference predicate device – Implant-borne Prosthetics CAD
Enhancements of the software, since the reference predicate K093113 was cleared, have been introduced through the other reference predicates and other implant-borne predicate devices, which include the indications of single tooth Ti-bases, bridges on Ti-bases, onepiece abutments and screw-retained bridges/bars:
Performance Testing
Performance Testing - Bench
Software verification and validation testing was provided to demonstrate use of the Straumann CARES Visual and Nova Dental CAD software device for controlling the design specifications and material selections for any prospective compatible abutment design library that undergoes separate 510(k) clearance for the resultant abutment devices.
Software verification and validation testing was conducted to demonstrate that the restrictions prevent design of the patient-matched components of the prospective compatible abutment design libraries for the workflow options of customizable two-piece abutments, one-piece abutments, and bridges and bars affixed to the endosseous dental implants from being outside of the allowable design limitations, including representative screenshots under user verification testing. In addition, the software verification and validation testing established that the design limitations and specifications of prospective compatible implantabutment design libraries are locked and cannot be modified by the end user.
10
Straumann CARES Visual and Nova Dental CAD
Summary
Device Software Functions
Software, verification and validation testing was performed in accordance with the FDA Guidance Document "Content of Premarket Submissions for Device Software Functions" (Issued on June 14, 2023).
Conclusion
The documentation submitted in this premarket notification demonstrates that the subject devices are substantially equivalent to the primary predicate and reference devices.