(225 days)
No
The summary describes standard CAD software for dental abutment design and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device is a software for designing dental implant abutments, which is an aid to restoration, and not the therapeutic device itself.
No
The device is described as design software for dental implant abutments, intending to aid in the restoration of chewing function, not to diagnose a medical condition or disease.
Yes
The device description explicitly states it is a "stand-alone software platform" and its output is a "computer file". There is no mention of accompanying hardware being part of the device itself.
Based on the provided information, the DTX Studio design software is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that the software is used to design dental abutments based on surface scan data of teeth and implant positions. It does not analyze biological samples like blood, urine, or tissue.
- The purpose of an IVD is to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The DTX Studio design software's purpose is to aid in the restoration of chewing function by designing a physical device (dental abutment) that will be manufactured and placed in the patient's mouth. It is a design tool for a medical device, not a diagnostic tool.
The software falls under the category of a medical device software used in the design and manufacturing process of a dental prosthetic. The predicate device listed (3Shape Abutment Designer Software) also supports this classification, as similar software is typically regulated as medical device software, not IVDs.
N/A
Intended Use / 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 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.
Product codes
PNP, NHA
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 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. 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 3rd 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 3rd 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 3rd 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Surface scan data, Desktop scanners, Intraoral scanners
Anatomical Site
Mandibles and maxillae (partially or fully edentulous)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental laboratory staff or a dental practitioner / dental clinic or a dental laboratory (implied)
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)
The performance of the subject device was verified and validated following the guidance provided in FDA Guidance General Principles of Software Validation. This documentation includes testing which demonstrates that the requirements for the features have been met. Software documentation for Moderate Level of Concern and description of respective V&V activities, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, is also included as part of this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
3Shape Abutment Designer Software K151455
Reference Device(s)
DTX Studio design K171466
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
0
Image /page/0/Picture/0 description: The image contains the 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 logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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.
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/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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
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3
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: (714) 282-4800 x7830 Fax: (714) 998-9348
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
4
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.
5
Nobel Biocare AB Traditional 510(k)
VI. Comparison of Technological Characteristics
| | Subject Device
DTX Studio design | Primary Predicate
3Shape Abutment Designer
Software K151455 | Reference Predicate
DTX Studio design
K171466 | Notes |
|-------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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,
one-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. | 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 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. | Equivalent to
primary predicate.
Patient specific is
added since the
software is used to
design customized
dental abutments,
based on the
patient anatomy. |
| Regulation Number | 21 CFR 872.3630 | 21 CFR 872.3630 | 21 CFR 872.3630 | Same |
| Regulation Name: | Endosseous Dental Implant
Abutment | Endosseous Dental Implant
Abutment | Endosseous Dental Implant
Abutment | Same |
| Regulatory Class | 2 | 2 | 2 | Same |
| Products Code* | PNP, NHA | PNP | NHA, NOF | See note below. |
| Intended user | Dental practitioner or dental
laboratory staff | Dental practitioner or dental
laboratory staff | Dental practitioner or dental
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
DTX Studio design | Primary Predicate
3Shape Abutment Designer
Software K151455 | Reference Predicate
DTX Studio design
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,
based on the country of the user
and the regulatory status. | Locked libraries for US | Controlled availability of products,
based on the country of the user
and the regulatory status. | Same as reference
predicate |
| User able to modify
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
manufactured prosthetics
(per 872.3630) | No | No | No | Same |
| Milling location | Abutment Manufacturer or Dental
laboratory per the 510k clearance of
the dental abutment | Abutment Manufacturer or Dental
laboratory per the 510k clearance of
the dental abutment | Nobel Biocare | Same as primary
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
libraries | Yes | Yes | Yes | Same |
| 3rd party prosthetic
libraries | Yes | Yes | No | Same as primary
predicate |
| CAD tools | | | | |
| Measurement tool | Yes | Yes | Yes | Same |
| Align meshes | Yes | Yes | Yes | Same |
| Annotations | Yes | Yes | Yes | Same |
| | Subject Device
DTX Studio design | Primary Predicate
3Shape Abutment Designer
Software K151455 | Reference Predicate
DTX Studio design
K171466 | Notes |
| Virtual articulator | ત્વની દિવેલા તાલુકામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં મુખ્યત્વે ખેત-ઉપયોગ તાલુકામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખે | ત્વની દિવેલા તાલુકામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખેતી, ખેતમજૂરી તેમ જ પશુપાલન છે. આ ગામમાં મુખ્યત્વે ખેત-ઉપયોગ તાલુકામાં આવેલું એક ગામના લોકોનો મુખ્ય વ્યવસાય ખે | Yes | Same |
| Screenshot tool | Yes | Yes | Yes | Same |
6
Nobel Biocare AB Traditional 510(k)
DTX Studio design K181932
7
Nobel Biocare AB Traditional 510(k)
DTX Studio design K181932
Notes:
- Changes to subject software include both local and centralized milling of dental abutments, therefore PNP and NHA are included
**The design of a wax up abutment starts from an intial shape based on a scan of a wax up technique). The abutment design is then further optimized within DTX Studio design using CAD tools.
8
VII. Discussion
The Indications for Use between the subject and the primary predicate devices are equivalent and the minor differences are to provide more clarity to the user, but do not alter the intended clinical use of the subject device.
DTX Studio design and the predicate 3Shape Abutment Designer Software are both standalone software used for the CAD design of dental abutments. Both software utilize a graphic user interface with a large 3D based main window, several visualization tools and implement a system of wizards that guide the user through all steps of the workflows.
DTX Studio design and the predicate include similar tools for the management of patient cases and for tracking the orders, can import of surface scan data and use proprietary file formats (for supporting specific desktop scanners), and can import an open file format.
DTX studio design provides similar CAD tools to design the same types of dental abutments available in the predicate 3Shape Abutment Designer. If the dental abutment design exceeds the safety limits, the user can experience a warning and a "hard stop", meaning that the user cannot continue designing, in the subject and predicate devices do not allow end-users changing the implant settings or safety limits in the libraries.
Both devices are capable of exporting the digital design to be used for manufacturing of the physical device, either by means of a proprietary format or an open format, such as the STL format.
VIII. Performance Data
DTX Studio design is designed and manufactured under the Quality System Regulations as outline in 21 CFR § 820 and ISO 13485:2016 Standards. This device is in conformance with the applicable parts of EN IEC 62304:2006 standards. Design Control Activities, including risk management following the ISO 14971:2012, verification/validation testing, were 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. This documentation includes testing which demonstrates that the requirements for the features have been met. Software documentation for Moderate Level of Concern and description of respective V&V activities, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005, is also included as part of this submission.
IX. Conclusion
Based on the comparison of the intended use, the features and workflows, the user interface, the technical characteristics, and based on the software verification activities described in this submission, DTX Studio design is found to be substantially equivalent to the identified Predicate Device.