BRILLIANT COMPONEER

K191385 · Coltene/Whaledent AG · EBF · Oct 29, 2019 · Dental

Device Facts

• Record ID: K191385
• Device Name: BRILLIANT COMPONEER
• Applicant: Coltene/Whaledent AG
• Product Code: EBF · Dental
• Decision Date: Oct 29, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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 - Optimisation of old composite restorations - Extending incisors - Correction of malpositioned teeth - Cosmetic corrections for tooth discolouration or incorrect shading - Closure of diastema

Device Story

BRILLIANT COMPONEER is a prefabricated, polymerized, highly filled, submicron hybrid composite enamel shell used for direct veneering of front teeth and premolars. It functions as a ready-made enamel layer, eliminating the need for clinicians to model the basic tooth shape during restoration. The device is applied by a dentist in a clinical setting; the clinician selects the appropriate shade and shape shell, which is then bonded to the tooth surface. By providing a pre-formed anatomical structure, the device simplifies the restoration process, improves aesthetic outcomes, and reduces chair time. It is intended for single-patient, single-use applications.

Clinical Evidence

No clinical or animal data provided. Substantial equivalence is supported by bench testing and biocompatibility assessments. Bench testing included water sorption, solubility, flexural strength, compressive strength, elastic modulus, filler particle size distribution, surface hardness, and radiopacity, all conforming to ISO 4049. Biocompatibility testing included cytotoxicity, bacterial reverse mutation, systemic toxicity, irritation, and sensitization, conforming to ISO 10993-1 and ISO 7405.

Technological Characteristics

Prefabricated hybrid composite enamel shells composed of methacrylate resin matrix with barium glass and silica fillers. Dimensions vary by size (S, M, L, XL) and tooth type (maxillary/mandibular). Non-sterile, single-use. Performance conforms to ISO 4049. Biocompatibility conforms to ISO 10993-1. No electronic components or software.

Indications for Use

Indicated for patients requiring dental restoration of caries, tooth fractures, anatomical malformations, or reconstruction of tooth substance lost to attrition, abrasion, or erosion. Also indicated for cosmetic corrections including diastema closure, extending incisors, correcting malpositioned teeth, addressing discoloration/shading, and optimizing existing composite restorations.

Regulatory Classification

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.

Predicate Devices

• COMPONEER (K112168)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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## 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.

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# % 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: | [phone] |
| Email: | [e-mail] |

#### 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,<br>Switzerland | Coltène/Whaledent AG,<br>Switzerland |
| 510(k) # | K191385 | K112168 |
| Product Code | EBF | EBF |
| Classification<br>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<br>hybrid composite enamel<br>shells. | Polymerized prefabricated<br>hybrid composite enamel<br>shells. |
| Structure: | Polymer resin composite | Polymer resin composite |
| Resin Matrix<br>Monomers: | Methacrylates | Methacrylates |
| Inorganic Filler: | Barium glass and silica | Barium glass and silica |
| Sizes: | Maxillary veneers available in<br>size S, M, L and XL.<br><br>Mandibular veneers available<br>in in sizes S or M | Maxillary veneers available in<br>size S, M, L and XL.<br><br>Mandibular veneers available<br>in in sizes S or M |
| Indications for<br>Use | Clinical indications:<br>- Restoration of caries defects<br>- Reconstruction of lost tooth<br>substance due to attrition,<br>abrasion, erosion<br>- Restoration of tooth fractures<br>- Correction of anatomical<br>malformation<br><br>Cosmetic indications<br>- Optimisation of old composite | - Restoration therapy for caries<br>- Optimization of old<br>restorations<br>- Extending incisors<br>- Malpositioned teeth<br>- Tooth fractures<br>- Tooth discoloration, incorrect<br>shading<br>- Anatomical malformation<br>- Diastema<br>- Attrition, abrasion, erosion |
| Attributes | Subject Device | Primary Predicate Device |
| | BRILLIANT COMPONEER | COMPONEER |
| | restorations<br>- Extending incisors<br>- Correction of malpositioned<br>teeth<br>- Cosmetic corrections for tooth<br>discolouration or incorrect<br>shading<br>- 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.

- 1. EN ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
- 2. EN ISO 14971:2012 Medical devices Application of risk management to medical devices.
- 3. 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
- 4. ISO 7405:2018 Dentistry Evaluation of biocompatibility of medical devices used in dentistry
- 5. 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.