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Coltene Brilliant

by Bauer, Cheng & Associates, Inc.

510(k) K840085

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK840085 Date16 Mar 1984ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EBF
Device Class
Class II
Regulation
21 CFR Part 872.3690
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

COLTENE BRILLIANT is a dental device classified under the FDA 510(k) regulatory pathway, with a decision of Substantially Equivalent. It is associated with the Dental advisory committee and has a product code of EBF.

The device is intended for use in dental applications and is supplied as part of the COLTENE BRILLIANT product line. It is not specified as single-use or reusable, and no specific storage or size details are provided in the data.

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Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the COLTENE BRILLIANT device intended for?

    The COLTENE BRILLIANT device is intended for use in dental applications, as specified in its FDA 510(k) submission under product code EBF, which covers general dental instruments and materials.

  • How is the COLTENE BRILLIANT device supplied and is it single-use or reusable?

    The COLTENE BRILLIANT device is supplied as part of the COLTENE BRILLIANT product line; however, the data does not specify whether it is designated for single-use or reusable application, so users should consult the manufacturer's labeling for reuse instructions.

  • What regulatory pathway was used for the COLTENE BRILLIANT device and what was the outcome?

    The COLTENE BRILLIANT device underwent the FDA Traditional 510(k) pathway, receiving a Substantially Equivalent (SESE) decision on March 16, 1984, under K840085, indicating it met safety and effectiveness requirements compared to a predicate device.