NobelDesign, DTX Studio Design
Device Facts
| Record ID | K171466 |
|---|---|
| Device Name | NobelDesign, DTX Studio Design |
| Applicant | Nobel Biocare AB |
| Product Code | NHA · Dental |
| Decision Date | Nov 29, 2017 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3630 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device |
Intended Use
The software is intended to be used at a dental clinic or a dental laboratory. The software uses patient-specific data from scanners, e.g. a scanned geometry, and facilitates the CAD of individual restorative solutions based on these data, such as a supporting dental framework, dental abutments, copings, crowns, and bridges. The software also serves as a means of creating and managing of cases, and the ordering of products.
Device Story
NobelDesign/DTX Studio design is an integrated CAD software application for dental clinics and laboratories. It ingests digital surface scan data (intra-oral or extra-oral) representing patient oral geometry. Users manage cases, scan models, and perform virtual CAD of dental prosthetics. The software integrates with NobelClinician for treatment plan data exchange. Output is either an encrypted proprietary file (NDO) sent to Nobel Biocare facilities for manufacturing or an exported STL file for local manufacturing of specific prosthetic restorations (excluding implant/abutment interfaces). The software assists clinicians and technicians in designing restorative solutions, improving workflow efficiency and enabling the creation of patient-specific dental prosthetics.
Clinical Evidence
Bench testing only. Software verification and validation were performed following FDA guidance, including end-to-end testing (scan, design, order) for worst-case scenarios. Documentation provided for Moderate Level of Concern software.
Technological Characteristics
PC-based Windows software. Integrated CAD functionality. Supports STL import/export. Connectivity includes data exchange with NobelClinician and cloud/networked ordering to Nobel Biocare facilities. Complies with IEC 62304:2006 and ISO 14971:2012.
Indications for Use
Indicated for use in dental clinics or laboratories to facilitate CAD of restorative solutions (frameworks, abutments, copings, crowns, bridges) using patient-specific scan data. Supports maxilla and mandible restorations.
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
- NobelDesign Software (K153036)
Reference Devices
- 3M Lava Software (K062493)
- Zfx Dental CAD System (K121709)
- NobelClinician (K163122)
Related Devices
- K153036 — NobelDesign Software · Nobel Biocare AB · Jun 2, 2016
- K181932 — DTX Studio design · Nobel Biocare AB · Mar 1, 2019
- K233252 — Straumann CARES Visual and Nova Dental CAD · Institut Straumann AG · Dec 26, 2024
- K121709 — ZFX DENTAL CAD SYSTEM · Zimmer Dental, Inc. · Oct 19, 2012
- K200100 — Abutment Design · 3Shape A/S · Oct 7, 2020
Submission Summary (Full Text)
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November 29, 2017
Nobel Biocare AB % Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Sasvi Ranch Parkway Yorba Linda, California 92887
Re: K171466
Trade/Device Name: NobelDesign, DTX Studio Design Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, NOF Dated: November 2, 2017 Received: November 3, 2017
Dear Charlemagne Chua:
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.
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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
for 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) K171466
Device Name NobelDesign /DTX Studio Design
### Indications for Use (Describe)
The software is intended to be used at a dental laboratory. The software uses patient-specific data from scanners, e.g. a scanned geometry, and facilitates the CAD of individual restorative solutions based on these data, such as a supporting dental framework, dental abutments, copings, crowns, and bridges. The software also serves as a means of creating and managing of cases, and the ordering of products."
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
- Over-The-Counter Use (21 CFR 801 Subpart C)
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# 1.0 510(k) Summary
#### I. Submitter
Submitted by:
Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887
Contact Person: Charlemagne Chua, Senior Regulatory Affairs Manager Phone: (714) 282-4800 x7830 Fax: (714) 998-9348
Submitted for:
Nobel Biocare AB Vastra Hamngatan 1 Goteborg, SE-411 17 Sweden
Date prepared: November 28, 2017
#### II. Device
Device Proprietary Names:
| Trade name No. 1: | NobelDesign |
|------------------------------|------------------------------------|
| Trade name No. 2: | DTX Studio design |
| Primary Classification Name: | Endosseous Dental Implant Abutment |
| Primary Regulation Number: | 21 CFR 872.3630 |
| Primary Product Code: | NHA |
| Device Classification | 2 |
| Secondary Product Code: | NOF |
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#### Predicate Device III.
Substantial equivalence is claimed to the following predicate devices:
- Primary Predicate: ●
- o NobelDesign Software, K153036, Nobel Biocare
- Reference Predicates
- 3M Lava Software, K062493, 3M ESPE AG o
- o Zfx Dental CAD System, K121709, Zimmer Dental Inc.
#### Device Description IV.
NobelDesign (also marketed as DTX Studio design) is an integrated CAD Software in a cockpit application that enables the user to design dental restorations.
The software receives and reads scan data containing topographical characteristics of real teeth and dental impressions from extra and intra-oral scanners. The NobelDesign/DTX Studio design software uses the data and it integrates a third-party software used to perform the CAD design of the dental restorations.
Using this software, the user can create and track cases, scan models and design prosthetics restorations (excluded implant/abutment interface). The output of the device is a computer file which contains the dental restoration design in a digital form. The dental restoration is manufactured in Nobel Biocare registered facilities using the digital format. Prosthetic restorations (excluding prosthetic restorations with implant/abutment interface or as part of a multi-piece or Ti-base abutment under 872.3630, NHA) can also be designed with the software but can be manufactured in the dental lab, using 510k cleared material for this purpose (872.3770, EBG).
NobelDesign/DTX Studio design includes the following features:
- Case Manager: enter and edit the general information of the case, the patients details . as well as information related to the restorations to be designed;
- Scan Center: allows for scanning the needed objects for designing all types of supported restorations;
- CAD Design: allows for virtual design of different types of restorations; ●
- Integrated workflow with NobelClinician (K163122)
- Order Manager: allows for ordering designed components and order tracking
- Export of digital design (.STL) for prosthetic restorations (e.g., TempShell or other ● prosthetic restorations that exclude devices with implant/abutment interface or as part
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of a multi-piece or Ti-base abutment under 872.3630, NHA), per 872.3661, NOF
Each Nobel Biocare abutment designed in the software has been previously FDA cleared with its own specifications and requirements.
#### V. Indications for Use
The software is intended to be used at a dental clinic or a dental laboratory. The software uses patient-specific data from scanners, e.g. a scanned geometry, and facilitates the CAD of individual restorative solutions based on these data, such as a supporting dental framework, dental abutments, copings, crowns, and bridges. The software also serves as a means of creating and managing of cases, and the ordering of products.
#### VI. Comparison of Technological Characteristics
NobelDesign/DTX Studio design and the previous cleared NobelDesign version share the following characteristics:
- Intended for design of dental restorative solutions for the maxilla and mandible .
- Integrated CAD software ●
- Supports use of imaging data imported from extra-oral scanners. ●
- Allows for ordering designed restorations from Nobel Biocare manufacturing facilities.
NobelDesign/DTX Studio design is different from the previous cleared NobelDesign version as follows:
- . Allows for exchange of treatment plan data with NobelClinician (K163122)
- Supports use of imaging data imported from intra-oral scanners (e.g. STL import). ●
- Design of prosthetic restorations (e.g., TempShell or other prosthetic restorations that ● exclude devices with implant/abutment interface or as part of a multi-piece or Ti-base abutment under 872.3630, NHA), per 872.3661, NOF
- New User Interface layout and tools to facilitate the execution of common tasks. ●
- Increased number of supported products compared to NobelDesign v1.0 ●
List of restorations available in the software:
| Product name | 510k reference |
|---------------------------------|----------------|
| Procera Implant Bridge Zirconia | K974150 |
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| Nobelactive Wide Platform (WP) | K133731 |
|---------------------------------------------------------------------|---------|
| Esthetic Zirconia Abutment | K031719 |
| NobelActive Zirconia Abutment | K072129 |
| NobelProcera Angulated Screw Channel Abutment Conical Connection | K132746 |
| NobelProcera Ti Abutment | K091756 |
| NobelProcera Ti Abutment Camlog Platforms | K122602 |
| NobelProcera Zi Abutment | K091904 |
| Procera Implant Bridge Zirconia | K053091 |
| NobelProcera Implant Bridge Zirconia | K091907 |
| Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 | K041236 |
| Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052 | K043042 |
| NobelProcera Implant Bridge | K091848 |
| NobelProcera HT ML Full Contour Zirconia Crown | K153534 |
| Procera Copings and Pontic | K032562 |
| Procera Bridge Zirconia | K041283 |
| Procera Bridge Zirconia | K053125 |
| Procera Bridge Zirconia 9 Units-14 Units, Models 30-4004 To 30-4013 | K071182 |
| Coping CoCr | Exempt* |
| Bridge CoCr | Exempt* |
| TempShell | K171466 |
*Note: Exempt devices per 872.3710 (EJH).
A short comparison of the subject and all predicate devices is provided in the table below.
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# NobelDesign/DTX Studio design Traditional 510(k)
| Criteria | NobelDesign/DTX<br>Studio design<br>(Subject Device) | NobelDesign Software<br>K153036<br>(Primary Predicate) | 3M Lava Software<br>K062493<br>(Reference Predicate) | Zfx Dental CAD System<br>K121709<br>(Reference Predicate) | Notes |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use Statement | The software is intended<br>to be used at a dental<br>clinic or a dental<br>laboratory. The software<br>uses patient-specific data<br>from scanners, e.g. a<br>scanned geometry, and<br>facilitates the CAD of<br>individual restorative<br>solutions based on these<br>data, such as a<br>supporting dental<br>framework, dental<br>abutments, copings,<br>crowns, and bridges. The<br>software also serves as a<br>means of creating and<br>managing of cases, and<br>the ordering of products. | The NobelDesign<br>Software uses patient-<br>specific data from<br>scanners and defines the<br>shapes of dental<br>prosthetic devices such<br>as dental abutments,<br>copings, crowns and<br>bridges through the use<br>of a CAD tool. The<br>software also serves as a<br>means of creating,<br>ordering and managing<br>cases. | The Lava software is<br>used with 3M ESPE's<br>Lava system, an all-<br>ceramic system for the<br>CAD/CAM fabrication<br>of dental restorations<br>such as inlays, onlays,<br>veneers, crowns and<br>bridges.<br>The software controls the<br>measuring process,<br>processing of the<br>measurement data (3D-<br>CAD tool), and export of<br>the data to the milling<br>machine. In addition,<br>various patient and case<br>information elements can<br>be entered. Other<br>functions are available<br>for verification and<br>service of the measuring<br>system.<br>The Lava software also<br>facilitates the transfer of<br>3D data from a scanner<br>to a remote milling<br>machine via internet. | The Zfx Dental CAD<br>System is intended to allow<br>the user to acquire patient<br>specific data via a scan or<br>digital file and define the<br>shapes of dental prosthetic<br>devices such as dental<br>abutments, crowns, bridges,<br>copings, in-lays, on-lays,<br>and veneers through the use<br>of a 3D-CAD tool. Zfx<br>Dental CAD System creates<br>an output file of the<br>restorations designed by the<br>user that can be<br>manufactured using a CAM<br>system. | Change: inclusion of<br>indication of<br>professional use,<br>difference in verbiage<br>(to ensure more<br>clarity to the<br>indications) |
| Classification<br>code | NHA, NOF | NHA | NHA, EIH | NHA, NOF | Change: addtionl of<br>NOF product code |
| Criteria | NobelDesign/DTX<br>Studio design<br>(Subject Device) | NobelDesign Software<br>K153036<br>(Primary Predicate) | 3M Lava Software<br>K062493<br>(Reference Predicate) | Zfx Dental CAD System<br>K121709<br>(Reference Predicate) | Notes |
| Anatomic areas | Maxilla<br>Mandible | Maxilla<br>Mandible | Maxilla<br>Mandible | Maxilla<br>Mandible | Same |
| Design options | Prosthetic restorations<br>such as dental abutments,<br>copings, crowns and<br>bridges. Allows for<br>selection of specific<br>Nobel Abutment designs<br>including material<br>composition | Dental restorations such<br>as dental abutments,<br>copings, crowns and<br>bridges. Allows for<br>selection of specific<br>Nobel Abutment designs<br>including material<br>composition | Dental restorations such<br>as inlays, onlays,<br>veneers, crowns and<br>bridges | Dental prosthetic devices:<br>dental abutments, crowns,<br>bridges, copings, in-lays,<br>on-lays, and veneers | Same |
| Computer<br>format | PC – Windows based | PC - Windows based | PC – Windows based | PC – Windows based | Same |
| CAD<br>component | Integrated | Integrated | Information not available | Integrated | Same |
| Input | Digital surface scan data<br>image/impression of the<br>patient's oral<br>environment from intra-<br>or extra-oral scanners.<br>Allows for exchange of<br>treatment plan data with<br>NobelClinician. | Digital data from<br>desktop scanner | Open digital file from a<br>scanner (STL) | STL file from a scanner | Change: Added<br>support of intra-<br>oral scanners and<br>interface with<br>treatment planning<br>software |
| Output | Encrypted proprietary<br>format (NDO file) sent to<br>Nobel Biocare<br>manufacturing facility.<br>Encrypted and non-<br>encrypted CAD design of<br>a prosthetic restoration | Encrypted proprietary<br>format (NDO file) sent to<br>Nobel Biocare<br>manufacturing facility | 3D data (plain scan data<br>or fully modelled data).<br>Project file to be sent for<br>milling<br>STL file 3D data (plain<br>scan data or fully<br>modelled data). Project<br>file to be sent for milling | STL file to a Zimmer Dental<br>milling center | Change: Added option<br>to export a non-<br>encrypted STL file of<br>prosthetic restorations<br>such as the TempShell<br>or other prosthetic<br>restorations, excluding<br>devices with<br>implant/abutment |
| Criteria | NobelDesign/DTX<br>Studio design<br>(Subject Device) | NobelDesign Software<br>K153036<br>(Primary Predicate) | 3M Lava Software<br>K062493<br>(Reference Predicate) | Zfx Dental CAD System<br>K121709<br>(Reference Predicate) | Notes |
| | such as the TempShell<br>(STL file) | | | | interface or as part of<br>a multi-piece or ti-<br>base abutment under<br>872.3630, NHA |
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# Discussion:
NobelDesign/DTX Studio design allows the design of prosthetics restorations. Compared to previous NobelDesign 1.0, the new software version 1.4 supports more Nobel Biocare products, it allows the exchange of treatment plan with NobelClinician (K163221), it now supports use of imaging data from an intra-oral scanner (e.g. STL import); it allows the design and exporting of prosthetic restorations (excluding prosthetic restorations with implant/abutment interface or as part of a multi-piece or Ti-base abutment under 872.3630, NHA), per 872.3661, NOF. The prosthetic restorations (excluding prosthetic restorations with implant/abutment interface or as part of a multi-piece or Ti-base abutment under 872.3630, NHA) can then be manufactured in the dental lab, using a 510k cleared material for this purpose.
The functionality of design prosthetic restorations under 872.3661, NOF code was cleared within the Zfx Dental CAD System, K121709, while the functionality of exporting digital design data for manufacturing on a local milling machine was cleared within the 3M Lava Software (K062493). Compared with the NobelDesign 1.0, a similar capability will now be available for NobelDesign/DTX Studio design for prosthetic restorations (excluding prosthetic restorations with implant/abutment interface or as part of a multi-piece or Tibase abutment under 872.3630, NHA), per 872.3661, NOF.
Prosthetic restorations with implant/abutment interface or as part of a multi-piece or Ti-base abutment under 872.3630. NHA will be sent to a Nobel Biocare FDA registered facility for validation of the design for appropriate dimensions and manufacturing.
#### VII. Performance Data
The device is designed and manufactured under the Quality System Regulations as outline in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of IEC 62304:2006 standards.
Design Control Activities including risk management following the ISO 14971:2012 verification/validation testing, was conducted and are included in this submission. The performance of the subject device was verified and validated following the guidance provided in FDA Guidance General Principles of Software Validation including an entire end-to-end validation (scan, design, and order) for multiple worst-case scenario scan and design requirements This documentation includes testing which demonstrates that the requirements for the features have been met. Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for
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Software Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission.
# VIII. Conclusion
Based on the substantial equivalence evaluation and the software verification/validation activities described above, NobelDesign/DTX Studio design is substantially equivalent to the identified previously predicate devices referenced in this submission.
