(195 days)
No
The summary describes a CAD software for dental restorations that uses scan data and integrates third-party CAD software. There is no mention of AI, ML, or related concepts in the intended use, device description, or other sections. The focus is on traditional CAD design and case management.
No
The device is a CAD software for designing dental restorations, not for providing therapy or treatment. Its output is a digital file for manufacturing, not a direct therapeutic intervention.
No
The device is described as software for Computer-Aided Design (CAD) of dental restorations, which facilitates the design and management of cases for manufacturing. It does not perform diagnostic functions such as identifying medical conditions or diseases.
Yes
The device description explicitly states it is "integrated CAD Software" and its output is a "computer file". It receives data from scanners but does not include the scanners themselves or any other hardware components. The validation focuses on software performance.
Based on the provided information, 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 described software, NobelDesign/DTX Studio design, is a CAD software used for designing dental restorations based on patient-specific scan data of the oral environment. It facilitates the creation of physical dental prosthetics.
- Lack of Specimen Analysis: The software does not analyze biological specimens from the human body. It processes digital representations of the patient's oral anatomy.
- Purpose: The purpose is to design and facilitate the manufacturing of dental restorations, not to diagnose, treat, or prevent disease through the analysis of biological samples.
The device falls under the category of dental CAD/CAM software, which is used in the design and manufacturing process of dental prosthetics. The predicate and reference devices listed (K153036, K062493, K121709) are also examples of dental CAD software, further supporting this classification.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
NHA, NOF
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital surface scan data image/impression of the patient's oral environment from intra- or extra-oral scanners.
Anatomical Site
Maxilla Mandible
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental clinic or a dental laboratory.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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.)
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the words "U.S. FOOD & DRUG ADMINISTRATION" on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the text.
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);
1
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
2
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)
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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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
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
5
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
Studio design
(Subject Device) | NobelDesign Software
K153036
(Primary Predicate) | 3M Lava Software
K062493
(Reference Predicate) | Zfx Dental CAD System
K121709
(Reference Predicate) | Notes |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use Statement | 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. | The NobelDesign
Software uses patient-
specific data from
scanners and defines the
shapes of dental
prosthetic devices such
as dental abutments,
copings, crowns and
bridges through the use
of a CAD tool. The
software also serves as a
means of creating,
ordering and managing
cases. | The Lava software is
used with 3M ESPE's
Lava system, an all-
ceramic system for the
CAD/CAM fabrication
of dental restorations
such as inlays, onlays,
veneers, crowns and
bridges.
The software controls the
measuring process,
processing of the
measurement data (3D-
CAD tool), and export of
the data to the milling
machine. In addition,
various patient and case
information elements can
be entered. Other
functions are available
for verification and
service of the measuring
system.
The Lava software also
facilitates the transfer of
3D data from a scanner
to a remote milling
machine via internet. | The Zfx Dental CAD
System is intended to allow
the user to acquire patient
specific data via a scan or
digital file and define the
shapes of dental prosthetic
devices such as dental
abutments, crowns, bridges,
copings, in-lays, on-lays,
and veneers through the use
of a 3D-CAD tool. Zfx
Dental CAD System creates
an output file of the
restorations designed by the
user that can be
manufactured using a CAM
system. | Change: inclusion of
indication of
professional use,
difference in verbiage
(to ensure more
clarity to the
indications) |
| Classification
code | NHA, NOF | NHA | NHA, EIH | NHA, NOF | Change: addtionl of
NOF product code |
| Criteria | NobelDesign/DTX
Studio design
(Subject Device) | NobelDesign Software
K153036
(Primary Predicate) | 3M Lava Software
K062493
(Reference Predicate) | Zfx Dental CAD System
K121709
(Reference Predicate) | Notes |
| Anatomic areas | Maxilla
Mandible | Maxilla
Mandible | Maxilla
Mandible | Maxilla
Mandible | Same |
| Design options | Prosthetic restorations
such as dental abutments,
copings, crowns and
bridges. Allows for
selection of specific
Nobel Abutment designs
including material
composition | Dental restorations such
as dental abutments,
copings, crowns and
bridges. Allows for
selection of specific
Nobel Abutment designs
including material
composition | Dental restorations such
as inlays, onlays,
veneers, crowns and
bridges | Dental prosthetic devices:
dental abutments, crowns,
bridges, copings, in-lays,
on-lays, and veneers | Same |
| Computer
format | PC – Windows based | PC - Windows based | PC – Windows based | PC – Windows based | Same |
| CAD
component | Integrated | Integrated | Information not available | Integrated | Same |
| Input | Digital surface scan data
image/impression of the
patient's oral
environment from intra-
or extra-oral scanners.
Allows for exchange of
treatment plan data with
NobelClinician. | Digital data from
desktop scanner | Open digital file from a
scanner (STL) | STL file from a scanner | Change: Added
support of intra-
oral scanners and
interface with
treatment planning
software |
| Output | Encrypted proprietary
format (NDO file) sent to
Nobel Biocare
manufacturing facility.
Encrypted and non-
encrypted CAD design of
a prosthetic restoration | Encrypted proprietary
format (NDO file) sent to
Nobel Biocare
manufacturing facility | 3D data (plain scan data
or fully modelled data).
Project file to be sent for
milling
STL file 3D data (plain
scan data or fully
modelled data). Project
file to be sent for milling | STL file to a Zimmer Dental
milling center | Change: Added option
to export a non-
encrypted STL file of
prosthetic restorations
such as the TempShell
or other prosthetic
restorations, excluding
devices with
implant/abutment |
| Criteria | NobelDesign/DTX
Studio design
(Subject Device) | NobelDesign Software
K153036
(Primary Predicate) | 3M Lava Software
K062493
(Reference Predicate) | Zfx Dental CAD System
K121709
(Reference Predicate) | Notes |
| | such as the TempShell
(STL file) | | | | interface or as part of
a multi-piece or ti-
base abutment under
872.3630, NHA |
8
9
10
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
11
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.