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Brilliant CompoNeer

FDA 510(k)

Class II (US FDA 510(k))

510(k) K191385

by Coltène/Whaledent AG

Identifiers

510(k) Number
K191385 FDA 510(k)
FDA Product Code
EBF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 872.3690 FDA 510(k)
Regulation Number
872.3690 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Brilliant CompoNeer is a prefabricated composite veneering system classified as a dental material for tooth shade restoration (product code EBF). It is designed for aesthetic anterior restorations, providing a sub-micron filler composite technology for enhanced polishability and long-lasting gloss retention in single-visit procedures.

This system is supplied as pre-shaped composite veneers and is intended for single-use applications in dental settings. The device has received FDA 510(k) clearance under the Traditional pathway, classified as Substantially Equivalent to a predicate device. It is not sterile at time of shipment and must be handled in accordance with standard dental practice guidelines.

Frequently asked questions

What types of dental restorations is the Brilliant CompoNeer specifically designed for, and how does its technology differ from traditional composites?

The Brilliant CompoNeer is designed exclusively for aesthetic anterior restorations, meaning it’s tailored for front teeth where appearance matters most. Its key innovation is a sub-micron filler composite technology, which improves polishability and helps maintain a long-lasting, high-gloss finish—ideal for single-visit procedures where immediate results are critical. Traditional composites often require multiple visits for polishing and may not retain shine as effectively over time.

Is the Brilliant CompoNeer meant for reuse, or is it intended to be used once and then discarded?

The Brilliant CompoNeer is intended for single-use only, as explicitly stated in its design and supply specifications. This aligns with standard dental practice guidelines for composite veneering systems to prevent cross-contamination and ensure patient safety. Each pre-shaped veneer is packaged for one-time clinical application.

How should the Brilliant CompoNeer be stored before use, and is it sterile upon arrival?

The Brilliant CompoNeer is not sterile at shipment and must be handled according to standard dental practice guidelines. It should be stored in a clean, dry environment, protected from moisture and direct sunlight, following the manufacturer’s instructions to maintain its integrity. Sterilization is not applicable since it’s a non-sterile dental material.

What regulatory pathway was followed for FDA clearance of the Brilliant CompoNeer, and what does ‘Substantially Equivalent’ mean in this context?

The Brilliant CompoNeer received FDA clearance via the Traditional 510(k) pathway, classified as *Substantially Equivalent (SESE)* to a predicate device. This means the FDA determined that its technology and intended use (aesthetic anterior restorations under product code EBF) are not significantly different from an already-cleared device, ensuring it meets safety and effectiveness standards without requiring a full de novo review.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: BRILLIANT COMPONEER | Online catalog - products.coltene.com, PDF Brilliant - Coltene, K191385 - BRILLIANT COMPONEER - Dental

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Coltène/Whaledent AG
FDA Applicant
Coltene/Whaledent AG

Sources (1)

  • FDA 510(k) K191385 24 fields · synced Sep 19, 2026