(159 days)
Not Found
No
The device description and performance studies focus on the material properties and physical form of the composite shells, with no mention of AI or ML capabilities.
No.
The device is used for restoration and correction of tooth defects and cosmetic issues, not for treating diseases or conditions with a therapeutic effect.
No
The device is a composite enamel shell used for direct restoration and cosmetic corrections of teeth, not for identifying a disease or condition.
No
The device description clearly states that the device is a "polymerized, highly filled, submicron hybrid composite enamel shell(s)", which is a physical material, not software.
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.
- Device Description and Intended Use: The description clearly states that BRILLIANT COMPONEER is a composite enamel shell used for direct veneering and restoration of teeth. This is a physical device applied directly to the patient's teeth for structural and cosmetic purposes. It does not involve testing samples taken from the body.
- Lack of IVD-related information: The document does not mention any analysis of biological samples, diagnostic purposes, or any of the typical characteristics of an IVD device.
Therefore, BRILLIANT COMPONEER is a dental restorative device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Indication
Clinical indications
- Restoration of caries defects
- Reconstruction of lost tooth substance due to attrition, abrasion, erosion
- Restoration of tooth fractures
- Correction of anatomical malformation
Cosmetic indications
- Optimisation of old composite restorations
- Extending incisors
- Correction of malpositioned teeth
- Cosmetic corrections for tooth discolouration or incorrect shading
- Closure of diastema
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
The subject device BRILLIANT COMPONEER is a polymerized, highly filled, submicron hybrid composite enamel shell(s) for direct veneering. It simplifies the direct restoration of front teeth and premolars without having to model the basic shape of the top enamel layer. The thin, anatomical composite shells are available in different shades and shapes allowing a natural, high aesthetic restoration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth (front teeth and premolars)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Non-Clinical Performance Testing was performed. This included biocompatibility testing (Chemical Characterization of Extractable Organic Compounds, In vitro Cytotoxicity Assay, Bacterial Reverse Mutation Assay, Acute Systemic Toxicity, Subchronic Systemic Toxicity, Biological Evaluation Report, Irritation Assessment, Acute Systemic Toxicity Assessment, Sensitization Assessment) and bench testing (Water sorption, Solubility, Flexural strength, Compressive Strength, Elastic Modulus, Filler Particle Size Distribution, Surface Hardness / Vickers hardness, Radiopacity). The test results showed that BRILLIANT COMPONEER is biocompatible and performs as intended based on the biocompatibility and bench tests according to the applicable standards. Animal and clinical performance testing was not included.
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).
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 29, 2019
Coltene/Whaledent AG Wolfgang Dorner Regulatory Affairs Specialist Feldwiesenstrasse 20 Altstatten, 9450 SWITZERLAND
Re: K191385
Trade/Device Name: BRILLIANT COMPONEER Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: July 29, 2019 Received: July 31, 2019
Dear Wolfgang Dorner:
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.
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
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K191385
Device Name BRILLIANT COMPONEER
Indications for Use (Describe) Indication
Clinical indications
- Restoration of caries defects
- Reconstruction of lost tooth substance due to attrition, abrasion, erosion
- Restoration of tooth fractures
- Correction of anatomical malformation
Cosmetic indications
- Optimisation of old composite restorations
- Extending incisors
- Correction of malpositioned teeth
- Cosmetic corrections for tooth discolouration or incorrect shading
- Closure of diastema
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW *
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
% COLTENE
K191385 Section 5 - 510(k) Summary
5.1 Submitter:
Coltène/Whaledent AG Feldwiesenstrasse 20 9450 Altstätten Sankt Gallen Switzerland
Submitter Contact: 5.2
| Contact: | Wolfgang Dörner |
|---|---|
| Title: | Regulatory Affairs Specialist |
| Phone: | +41 71 757 5422 |
| Email: | wolfgang.doerner@coltene.com |
5.3 Date Prepared
25th October 2019
5.4 Device Identification
| Type of 510(k) Submission: | Traditional 510(k) |
|---|---|
| 510(k) Number: | K191385 |
| Trade Name: | BRILLIANT COMPONEER |
| Common Name: | Tooth shade resin material |
| Regulation Number: | 872.3690 |
| Product Code: | EBF |
| Class: | II |
| Classification Panel: | Dental |
5.5 Primary Predicate Device
The primary predicate device is COMPONEER and is manufactured by Coltène/Whaledent AG in Switzerland. The primary predicate device was cleared in 2011 under the 510(k) number K112168.
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Image /page/4/Picture/1 description: The image shows the logo for COLTENE. The logo consists of a blue graphic on the left and the word "COLTENE" in black, bold letters on the right. The graphic is made up of six blue squares arranged in two rows of three, with the squares in the bottom row being a lighter shade of blue than the squares in the top row.
5.6 Indication for Use
BRILLIANT COMPONEER is indicated for: Clinical indications
- Restoration of caries defects -
- -Reconstruction of lost tooth substance due to attrition, abrasion, erosion
- -Restoration of tooth fractures
- -Correction of anatomical malformation
Cosmetic indications
- Optimization of old composite restorations -
- Extending incisors -
- -Correction of malpositioned teeth
- Cosmetic corrections for tooth discoloration or incorrect shading -
- Closure of diastema -
5.7 Device Overview
The subject device BRILLIANT COMPONEER is a polymerized, highly filled, submicron hybrid composite enamel shell(s) for direct veneering. It simplifies the direct restoration of front teeth and premolars without having to model the basic shape of the top enamel layer. The thin, anatomical composite shells are available in different shades and shapes allowing a natural, high aesthetic restoration (Figure 1).
Image /page/4/Picture/16 description: The image shows a dental veneer kit and some individual veneers. The kit includes a variety of tools and materials for applying the veneers, such as adhesives, applicators, and different sizes and shapes of veneers. The individual veneers are thin, tooth-colored shells that are designed to be bonded to the front surface of teeth to improve their appearance. The veneers are made of a ceramic material and have a natural-looking translucency.
Figure 1: BRILLIANT COMPONEER package overview and veneers (on the right).
5.8 Substantial Equivalence
A comparison of the subject device BRILLIANT COMPONEER to the primary predicate device COMPONEER (K112168) is provided in Table 1.
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Image /page/5/Picture/0 description: The image shows the word "COLTENE" in a bold, sans-serif font. To the left of the word is a graphic consisting of nine squares arranged in a 3x3 grid. The squares are colored in shades of blue, with the top row being the darkest and the bottom row being the lightest.
| Attributes | Subject Device | Primary Predicate Device |
|---|---|---|
| BRILLIANT COMPONEER | COMPONEER | |
| Device Name | BRILLIANT COMPONEER | COMPONEER |
| Manufacturer | Coltène/Whaledent AG, | |
| Switzerland | Coltène/Whaledent AG, | |
| Switzerland | ||
| 510(k) # | K191385 | K112168 |
| Product Code | EBF | EBF |
| Classification | ||
| Name: | Tooth shade resin material | Tooth shade resin material |
| Regulation | 21 CFR 872.3690 | 21 CFR 872.3690 |
| Class | II | II |
| Review Panel | Dental | Dental |
| Device Image | Image: BRILLIANT COMPONEER | Image: COMPONEER |
| Physical State: | Polymerized prefabricated | |
| hybrid composite enamel | ||
| shells. | Polymerized prefabricated | |
| hybrid composite enamel | ||
| shells. | ||
| Structure: | Polymer resin composite | Polymer resin composite |
| Resin Matrix | ||
| Monomers: | Methacrylates | Methacrylates |
| Inorganic Filler: | Barium glass and silica | Barium glass and silica |
| Sizes: | Maxillary veneers available in | |
| size S, M, L and XL. |
Mandibular veneers available
in in sizes S or M | Maxillary veneers available in
size S, M, L and XL.
Mandibular veneers available
in in sizes S or M |
| Indications for
Use | Clinical indications:
- Restoration of caries defects
- Reconstruction of lost tooth
substance due to attrition,
abrasion, erosion - Restoration of tooth fractures
- Correction of anatomical
malformation
Cosmetic indications
- Optimisation of old composite | - Restoration therapy for caries
- Optimization of old
restorations - Extending incisors
- Malpositioned teeth
- Tooth fractures
- Tooth discoloration, incorrect
shading - Anatomical malformation
- Diastema
- Attrition, abrasion, erosion |
| Attributes | Subject Device | Primary Predicate Device |
| | BRILLIANT COMPONEER | COMPONEER |
| | restorations - Extending incisors
- Correction of malpositioned
teeth - Cosmetic corrections for tooth
discolouration or incorrect
shading - Closure of diastema | - Cosmetic correction |
| Primary | Blisters with single veneers | Blisters with single veneers |
| Packaging | | |
| Usage | Single patient, single use | Single patient, single use |
| Sterility | Non-sterile | Non-sterile |
| Biocompatibility | Conforms with ISO 10993-1 | Conforms with ISO 10993-1 |
| Performance | Conforms with ISO 4049 | Conforms with ISO 4049 |
| Compressive | 285 MPa | 392 MPa |
| Strength: | | |
| Flexural | 125.4 MPa | 127 MPa |
| Strength: | | |
| Elastic | 9.8 GPa | 9.0 GPa |
| Modulus: | | |
| Radiopacity: | 3.24 mm of Al | 2 mm of Al |
| Water sorption: | 18.2 µg / mm³ | 16 µg / mm³ |
| Solubility: | 0.3 µg / mm³ | 0.9 µg / mm³ |
Table 1: Comparison of BRILLIANT COMPONEER and COMPONEER
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Image /page/6/Picture/0 description: The image shows the word "COLTENE" in a bold, sans-serif font. To the left of the word is a graphic consisting of six blue rectangles arranged in two rows of three. The rectangles in the top row are a darker shade of blue than the rectangles in the bottom row, creating a gradient effect. The word "COLTENE" is in black.
5.9 Non-Clinical Performance Testing
As part of demonstrating substantial equivalence of the subject device BRILLIANT COMPONEER to the primary predicate device COMPONEER, Coltène/Whaledent AG performed extensive testing of the finished device in accordance with the applicable parts of the following standards, as well as according to the company's additional internal test protocols.
-
- EN ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
-
- EN ISO 14971:2012 Medical devices Application of risk management to medical devices.
-
- FDA General Guidance: 2016 - Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
-
- ISO 7405:2018 Dentistry Evaluation of biocompatibility of medical devices used in dentistry
-
- ISO 4049:2009 Dentistry-Polymer-based filling, restorative and luting materials
The test results showed that BRILLIANT COMPONEER is biocompatible and performs as intended based on the biocompatibility and bench tests according to the applicable standards. In Table 2 a list of the conducted tests is provided.
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Image /page/7/Picture/1 description: The image shows the word "COLTENE" in bold, black letters. To the left of the word is a graphic of six blue squares arranged in two rows. The top row has three squares, and the bottom row has three squares. The squares are different shades of blue, with the top left square being the darkest and the bottom right square being the lightest.
Table 2: List of tests completed for BRILLIANT COMPONEER
| Biocompatibility |
|---|
| Chemical Characterization of Extractable Organic Compounds |
| In vitro Cytotoxicity Assay |
| Bacterial Reverse Mutation Assay |
| Acute Systemic Toxicity |
| Subchronic Systemic Toxicity |
| Biological Evaluation Report |
| Irritation Assessment |
| Acute Systemic Toxicity Assessment |
| Sensitization Assessment |
| Bench Testing |
| Water sorption |
| Solubility |
| Flexural strength |
| Compressive Strength |
| Elastic Modulus |
| Filler Particle Size Distribution |
| Surface Hardness / Vickers hardness |
| Radiopacity |
| Water sorption |
| Solubility |
Animal and clinical performance testing was not included.
5.10 Statement of Substantial Equivalence
BRILLIANT COMPONEER has a similar intended use, indications for use, physical and chemical attributes, as the predicate device COMPONEER. Any minor differences in the materials used to make the subject device, when compared to the predicate device, have been successfully evaluated by Coltène/Whaledent AG through extensive performance and biocompatibility testing on the device. In conclusion, the subject device BRILLIANT COMPONEER has been determined to be substantially equivalent to the predicate device COMPONEER.