(227 days)
Not Found
No
The summary describes a CAD software for dental prosthetics that uses scanned geometry and user-driven design tools. There is no mention of AI or ML algorithms being used for automated design, analysis, or decision-making. The "CAD Design" module is described as having "easy to use tools," implying manual or rule-based design rather than AI/ML-driven generation.
No
This device is software used to design dental prosthetics, which are then manufactured elsewhere. It is not directly therapeutic but rather a tool for creating products used in therapeutic procedures.
No
This device is a CAD software used for designing dental prosthetic devices based on patient-specific scanned data and managing cases. It does not perform diagnostic functions such as identifying diseases or conditions.
Yes
The device is described as "NobelDesign software" and its function is to facilitate the design and ordering of dental prosthetics using patient-specific scanned data. While it integrates with a scanner and production facility, the core device being described and cleared is the software itself, which performs the CAD design and case management functions. The description focuses solely on the software modules and their functionalities.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The NobelDesign Software is a CAD tool used to design dental prosthetic devices (abutments, copings, crowns, bridges) based on scanned patient geometry. It facilitates the creation, ordering, and management of these prosthetic devices.
- Lack of Biological Sample Analysis: The software does not analyze any biological samples from the patient. Its input is scanned geometric data, not biological material.
- Purpose: The purpose of the software is to design and facilitate the manufacturing of physical dental prosthetics, not to diagnose or provide information about a patient's health status based on biological samples.
Therefore, the NobelDesign Software falls under the category of a medical device used for the design and production of patient-specific dental prosthetics, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The NobelDesign Software uses patients data from scanners and defines the shapes of dental prosthetic devices such as dental abutinents, copings and bridges through the use of a CAD tool. The software also serves as a means of creating, ordering and managing cases
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
NobelDesign software is an integrated CAD Software in a cockpit application that enables the user to scan, design and order the designed products (prosthetics).
The software is a solution that allows the use of the NobelProcera 2G scanner and integrates a third party software which is used to perform the actual design (CAD design) for the previously cleared Nobel Biocare patient specific dental implant abutments and implant bridges.
Using this system it is possible for the user to create and track cases, scan models and order NobelProcera prosthetics from the global production resources of Nobel Biocare. NobelDesign v1.0 includes to the following modules:
- . Design Setup. Module to allow users to define restoration type and design on which tooth position
- Scan Center. Module to assist in acquiring all required scans for the design . setup.
- Case Management. Module with tools to help manage designs. ●
- Basic Application. Basic functionality (About, Help framework) are in place. ●
- Order Manager. Module for ordering designed components and order tracking. ●
- CAD Design. Module to allows designing of different types of restorations . virtually with easy to use tools.
Each physical product (prosthetic) which is 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
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Input Imaging Modality
STL file from a scanner
Anatomical Site
Maxilla
Mandible
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The software is intended to be used at a 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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Design Control Activities including risk management following the ISO 14971 verification/validation testing, was conducted and are included in this submission. The performance of the NobelDesign software 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.
Not Found
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).
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§ 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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected and appear to be emerging from a single form. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 2, 2016
Nobel Biocare AB % Charlemagne Chua Senior Regulatory Affairs Manager Nobel Biocare, USA LLC 22715 Savi Ranch Parkway Yorba Linda. California 92887
Re: K153036
Trade/Device Name: NobelDesign Software Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: April 21, 2016 Received: April 22, 2016
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
1
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
CEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K153036
Device Name NobelDesign Software
Indications for Use (Describe)
The NobelDesign Software uses patients data from scanners and defines the shapes of dental prosthetic devices such as dental abutinents, copings and bridges through the use of a CAD tool. The software also serves as a means of creating, ordering and managing cases
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
A.4 510(k) Summary
| Submitter: | Nobel Biocare AB |
|---|---|
| Address: | Vastra Hamngatan 1 |
| Goteborg, SWEDEN 411 17 | |
| Establishment Registration No. | 9611992 |
| Submitted By: | Nobel Biocare, USA LLC |
| 22715 Savi Ranch Parkway | |
| Yorba Linda, CA. 92887 | |
| Establishment Registration No. | 2027971 |
| Contact Person: | Charlemagne Chua |
| Senior Regulatory Affairs Manager | |
| Telephone: (714) 282-4800 | |
| Date Prepared: | June 2, 2016 |
| Classification and Device Name | |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | NHA (21 CFR 872.3630) |
| Trade/Propriety Name: | Nobel Design Software |
1. Predicate Device(s):
| 510(K) Number | Product Name | Manufacturer | Clearance Date |
|---|---|---|---|
| K053602 | Procera Software | Nobel Biocare | Feb 10, 2006 |
2. Reason for Submission:
New Device
3. Device Description:
NobelDesign software is an integrated CAD Software in a cockpit application that enables the user to scan, design and order the designed products (prosthetics).
The software is a solution that allows the use of the NobelProcera 2G scanner and integrates a third party software which is used to perform the actual design (CAD design) for the previously cleared Nobel Biocare patient specific dental implant abutments and implant bridges.
Using this system it is possible for the user to create and track cases, scan models and order NobelProcera prosthetics from the global production resources of Nobel Biocare. NobelDesign v1.0 includes to the following modules:
4
- . Design Setup. Module to allow users to define restoration type and design on which tooth position
- Scan Center. Module to assist in acquiring all required scans for the design . setup.
- Case Management. Module with tools to help manage designs. ●
- Basic Application. Basic functionality (About, Help framework) are in place. ●
- Order Manager. Module for ordering designed components and order tracking. ●
- CAD Design. Module to allows designing of different types of restorations . virtually with easy to use tools.
Each physical product (prosthetic) which is designed in the software has been previously FDA cleared with its own specifications and requirements.
4. Indications for Use:
The NobelDesign Software uses patient-specific data from scanners and defines the shapes of dental prosthetic devices such as dental abutments, copings and bridges through the use of a CAD tool. The software also serves as a means of creating, ordering and managing cases.
| Criteria | NobelDesign Software
(Subject Device) | Procera Software
(K053602)
Predicate Device | Notes |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | 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. | Nobel Biocare's Procera
Software imports patient
specific data from
scanners and defines the
shapes of dental prosthetic
devices such as dental
abutments, copings,
laminates and bridges
through the use of a 3D-
CAD tool. The software
also serves as means of
ordering and managing
orders of Procera products | Slight difference
with the addition
of crowns and
removal of
laminate. The
addition of
crowns to bridge
design does not
change the
intended use of
the device |
| Intended
use | The software is intended to
be used at a dental clinic or
a dental laboratory. The
software uses patient-
specific data, e.g., a
scanned geometry, and | The Procera Software is
intended to be used at the
lab/clinic to import patient
specific data (eg a scanned
geometry of a tooth) and
design a patient specific | Same |
| Criteria | NobelDesign Software
(Subject Device) | Procera Software
(K053602)
Predicate Device | Notes |
| facilitates the CAD of an
individual restorative
solution based on these
data, e.g., a supporting
dental framework. The
design data of the
individualized design and
any associated
standardized components
are transmitted via a
network to a production
facility where the
individualized prosthetic
device is manufactured. | restorative solution based
on these data (eg a dental
prosthetic framework or a
coping). The CAD designed
solution is sent via internet
to the Procera Production
facility. | | |
| Anatomic
areas | Maxilla
Mandible | Maxilla
Mandible | Same |
| Design
options | Dental abutments, copings,
crowns and bridges. Allows
for selection of specific
Nobel Abutment design
including material
composition | Dental abutments, copings,
laminates and bridges | The design
options allows for
inclusion of more
information in the
design output in
addition to just
dimensions. |
| Computer
format | PC - Windows based | PC - Windows based | Same |
| CAD
component | Integrated | Separate | The CAD module
contains similar
functions as the
predicate but is
not integrated
into a single
system with scan
and ordering
modules |
| Input | STL file from a scanner | STL file from a scanner | Same
(The compatible
scanner has
been updated
from the
predicate). |
| Output | Encrypted proprietary format
(.NDO file) sent to Nobel
Biocare manufacturing | Proprietary format (.bcf
.c3b file) sent to Nobel
Biocare manufacturing | The NobelDesign
file format (.NDO)
is the only |
| Criteria | NobelDesign Software
(Subject Device) | Procera Software
(K053602)
Predicate Device | Notes |
| | facility | facility. | encrypted file.
However, both file
formats are
proprietary and
contain
information for
the Nobel Biocare
manufacturing
facility. |
5. Comparison of Technological Characteristics
5
6
Discussion:
The identified differences between the submission device and the identified predicate do not affect the substantial equivalence of the device as the changes only allow for the amount and type of information provided by the dental laboratory to Nobel Biocare. The final abutment design and all other screw retained restorations (e.g., abutments, crowns and bridges) will continue to be sent to a Nobel Biocare facility for validation of the design for appropriate dimensions and manufacturing.
6. Testina
The device is designed and manufactured under the Quality System Requlation as outlined 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 verification/validation testing, was conducted and are included in this submission. The performance of the NobelDesign software 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 Software Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission.
7. Substantial Equivalence
Based on the substantial equivalence discussion and software verification //alidation activities described above. NobelDesign Software is substantially equivalent to the identified previously cleared predicate device referenced in this submission.