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Plaque Detection System

by Clairol, Inc.

510(k) K781919

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK781919 Date4 Dec 1978ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
NYH
Device Class
Class II
Regulation
21 CFR Part 872.1740
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

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

The Plaque Detection System is a dental device designed to identify and highlight dental plaque on tooth surfaces. It functions as a disclosing agent that makes plaque visible for assessment and oral hygiene instruction.

This device is supplied as a kit for use in dental settings. It is intended for professional or patient use to aid in plaque detection and is regulated under FDA 510(k) clearance as a Class II dental device with product code NYH.

Other devices from Clairol, Inc.

Questions

AI-generated answers, 21 Sep 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 Plaque Detection System used for?

    The Plaque Detection System is designed to identify and highlight dental plaque on tooth surfaces, functioning as a disclosing agent to make plaque visible for assessment and oral hygiene instruction in dental settings.

  • How is the Plaque Detection System supplied and intended for use?

    The device is supplied as a kit for use in dental settings and is intended for professional or patient use to aid in plaque detection, helping users visualize plaque buildup during oral hygiene routines.

  • What regulatory pathway was used for the Plaque Detection System?

    The Plaque Detection System received FDA 510(k) clearance as a Class II dental device with product code NYH, indicating it was found substantially equivalent to a legally marketed predicate device.