DTX Studio design

K181932 · Nobel Biocare AB · PNP · Mar 1, 2019 · Dental

Device Facts

• Record ID: K181932
• Device Name: DTX Studio design
• Applicant: Nobel Biocare AB
• Product Code: PNP · Dental
• Decision Date: Mar 1, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

DTX Studio design software is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. DTX Studio design software is intended to be used by dental laboratory staff or a dental practitioner for designing patient specific component of a two-piece, onepiece or hybrid dental implant abutment. The single or multiple patient specific abutment design is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.

Device Story

DTX Studio design (also known as DTX Studio Lab) is a standalone CAD software platform for designing patient-specific dental implant abutments. Input data includes surface scans (desktop or intraoral) of teeth, implant positions, and orientations. The software provides a 3D workspace with guided wizards, visualization tools, and CAD modules to design abutments based on verified prosthetic libraries. It enforces safety limits (e.g., minimum thickness, connection geometry) via warnings or hard stops. Output is a digital design file (e.g., .STL) sent to an FDA-registered facility or third-party provider for physical manufacturing. Used in dental clinics or laboratories by practitioners or technicians to facilitate restorative workflows, improve design accuracy, and enable centralized or local production of customized abutments.

Clinical Evidence

Bench testing only. No clinical data provided. Performance was verified and validated per FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices and General Principles of Software Validation. Testing confirmed requirements for features, risk management (ISO 14971:2012), and conformance to EN IEC 62304:2006.

Technological Characteristics

Standalone software platform; C++ programming; Windows 64-bit OS. Features 3D CAD design module, case management, and scan data import. Enforces design constraints via locked prosthetic libraries (connection geometry, thickness, angulation). Connectivity via file export (.STL). Software lifecycle follows ISO 13485:2016 and EN IEC 62304:2006.

Indications for Use

Indicated for partially or fully edentulous patients requiring restoration of chewing function via patient-specific two-piece, one-piece, or hybrid dental implant abutments. Intended for use by dental practitioners or laboratory staff.

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

• 3Shape Abutment Designer Software (K151455)

Reference Devices

• DTX Studio design (K171466)

Submission Summary (Full Text)

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March 1, 2019

Nobel Biocare AB % Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda. California 92887

Re: K181932

Trade/Device Name: DTX Studio design Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: PNP, NHA Dated: January 24, 2019 Received: January 28, 2019

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. 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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Andrew I. Steen -S

Tina Kiang, Ph.D. for 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) K181932

Device Name DTX Studio design

### Indications for Use (Describe)

DTX Studio design software is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. DTX Studio design software is intended to be used by dental laboratory staff or a dental practitioner for designing patient specific component of a two-piece or hybrid dental implant abutment. The single or multiple patient specific 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)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

### FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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# K181932 510(k) Summary

#### l. Submitter

Submitted by:

Nobel Biocare USA LLC 22715 Savi Ranch Parkway Yorba Linda, CA 92887

Contact Person: Charlemagne Chua Phone: [phone] x7830 Fax: [phone]

Submitted for:

Nobel Biocare AB Vastra Hamngatan 1 Goteborg, SE-411 17 Sweden

Date prepared: 03/01/2019

#### II. Device

Device Proprietary Name:

| Trade name: | DTX Studio design |
|--------------------------|-------------------------------------------------------------|
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | 21 CFR 872.3630 |
| Primary Product Code: | PNP (Dental Abutment Design Software for Dental Laboratory) |
| Secondary Product Code : | NHA (Endosseous Dental Implant Abutment) |
| Device Classification | 2 |

#### III. Predicate/Reference Devices

Substantial equivalence is claimed to the following predicate devices:

- Primary Predicate:
- o 3Shape Abutment Designer Software K151455
- Reference Predicate
- o DTX Studio design K171466

#### IV. Device Description

DTX Studio design* is a stand-alone software platform that integrates CAD software to render a design of a dental abutment. The software receives surface scan data containing topographical characteristics of real teeth, position and orientation of implants and uses also an integrated third-party software to

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perform the CAD design of the dental abutment. Additional functions include creating and tracking cases. The output of the device is a computer file containing the dental abutment in a digital form. *Note: DTX Studio design will transition to a new name and will also be known as DTX Studio Lab.

In accordance with the classification of the dental abutment and the related 510k clearance, the output file can be sent to an FDA registered facility or can be used by 3″ party providers to manufacture the physical dental abutment based on their 510(k) product clearance.

The following functionality was added compared with the previously cleared DTX Studio design (K171466) software:

- Allow the user to design and order a NobelProcera Bar;
- Extension of the function to import STL files from different scan sources; ●
- Dental abutments may be produced from scan data from 30d party scanners for centralized production;
- Dental abutment design requests including intraoral scan be received in DTX Studio design from a clinician;
- . Implementation of verified and validated prosthetic libraries provided by 3″ parties to allow design and export for localized production.

These libraries contain a number of design parameters and product constraints, such as connection geometry, minimum thickness, titanium base, implant lab analog, screw channel angle, maximum angulation for abutments/2-piece abutment/ hybrid crown, abutment post height above implant collar;

- . Export of digital design file (.STL) for dental implant abutment (per 872.3630, NHA) for local production of patient-specific abutment components.
DTX Studio design is programmed in C++ and can be run on standard consumer PC running Windows 64bit.

#### V. Indications for Use

DTX Studio design software is intended as an aid to the restoration of chewing function in partially or fully edentulous mandibles and maxillae. DTX Studio design software is intended to be used by dental laboratory staff or a dental practitioner for designing patient specific component of a two-piece, onepiece or hybrid dental implant abutment. The single or multiple patient

specific abutment design is intended to be used by the manufacturer of an endosseous dental implant abutment to create the final device.

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Nobel Biocare AB Traditional 510(k)

#### VI. Comparison of Technological Characteristics

| | Subject Device<br>DTX Studio design | Primary Predicate<br>3Shape Abutment Designer<br>Software K151455 | Reference Predicate<br>DTX Studio design<br>K171466 | Notes |
|-------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use | DTX Studio design software is<br>intended as an aid to the restoration<br>of chewing function in partially or<br>fully edentulous mandibles and<br>maxillae. DTX Studio design software<br>is intended to be used by dental<br>laboratory staff or a dental<br>practitioner for designing patient<br>specific component of a two-piece,<br>one-piece or hybrid dental implant<br>abutment. The single or multiple<br>patient specific abutment design is<br>intended to be used by the<br>manufacturer of an endosseous<br>dental implant abutment to create<br>the final device. | The 3Shape Abutment Designer<br>Software is intended as an aid to the<br>restoration of chewing function in<br>partially or fully edentulous<br>mandibles and maxillae. The 3Shape<br>Abutment Designer Software is<br>intended for use by a dental<br>practitioner or dental laboratory<br>staff for designing the patient<br>specific component of a two-piece,<br>one-piece or hybrid dental implant<br>abutment. The single or multi-unit<br>abutment design is intended to be<br>used by the manufacturer of an<br>endosseous dental implant<br>abutment to create the final device. | The software is intended to be used<br>at a dental clinic or a dental<br>laboratory. The software uses<br>patient-specific data from scanners,<br>e.g. a scanned geometry, and<br>facilitates the CAD of individual<br>restorative solutions based on these<br>data, such as a supporting dental<br>framework, dental abutments,<br>copings, crowns, and bridges. The<br>software also serves as a means of<br>creating and managing of cases, and<br>the ordering of products. | Equivalent to<br>primary predicate.<br>Patient specific is<br>added since the<br>software is used to<br>design customized<br>dental abutments,<br>based on the<br>patient anatomy. |
| Regulation Number | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 | Same |
| Regulation Name: | Endosseous Dental Implant<br>Abutment | Endosseous Dental Implant<br>Abutment | Endosseous Dental Implant<br>Abutment | Same |
| Regulatory Class | 2 | 2 | 2 | Same |
| Products Code* | PNP, NHA | PNP | NHA, NOF | See note below. |
| Intended user | Dental practitioner or dental<br>laboratory staff | Dental practitioner or dental<br>laboratory staff | Dental practitioner or dental<br>laboratory staff | Same |
| Features | | | | |
| Case management | Yes | Yes | Yes | Same |
| Scan module | Yes | Yes | Yes | Same |
| CAD Design module | Yes | Yes | Yes | Same |
| Order module | Yes | Yes | Yes | Same |
| User interface | Workspace with 3D model | Workspace with 3D model | Workspace with 3D model | Same |
| | Subject Device<br>DTX Studio design | Primary Predicate<br>3Shape Abutment Designer<br>Software K151455 | Reference Predicate<br>DTX Studio design<br>K171466 | Notes |
| Wizards | Yes | Yes | Yes | Same |
| Visualization tools | Yes | Yes | Yes | Same |
| Safety limitations | Yes (warning and/or hard block) | Yes (warning and/or hard block) | Yes (warning and/or hard block) | Same |
| Configuration and settings | Controlled availability of products,<br>based on the country of the user<br>and the regulatory status. | Locked libraries for US | Controlled availability of products,<br>based on the country of the user<br>and the regulatory status. | Same as reference<br>predicate |
| User able to modify<br>libraries | No | No | No | Same |
| Input | Desktop and intraoral scanners | Desktop and intraoral scanners | Desktop and intraoral scanners | Same |
| Output | Computer file containing CAD model | Computer file containing CAD model | Computer file containing CAD model | Same |
| Device includes pre<br>manufactured prosthetics<br>(per 872.3630) | No | No | No | Same |
| Milling location | Abutment Manufacturer or Dental<br>laboratory per the 510k clearance of<br>the dental abutment | Abutment Manufacturer or Dental<br>laboratory per the 510k clearance of<br>the dental abutment | Nobel Biocare | Same as primary<br>predicate |
| CAD Indications | | | | |
| Customized abutment | Yes | Yes | Yes | Same |
| Anatomical abutment | Yes | Yes | Yes | Same |
| Screw retained abutment | Yes | Yes | Yes | Same |
| Wax up abutment** | Yes | Yes | Yes | Same |
| Implant bridge design | Yes | Yes | Yes | Same |
| Consumables | | | | |
| Nobel Biocare prosthetic<br>libraries | Yes | Yes | Yes | Same |
| 3rd party prosthetic<br>libraries | Yes | Yes | No | Same as primary<br>predicate |
| CAD tools | | | | |
| Measurement tool | Yes | Yes | Yes | Same |
| Align meshes | Yes | Yes | Yes | Same |
| Annotations | Yes | Yes | Yes | Same |
| | Subject Device<br>DTX Studio design | Primary Predicate<br>3Shape Abutment Designer<br>Software K151455…