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Multiple Tooth Desensitizer

by Cosmedent, Inc.

510(k) K052263

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 26 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK052263 Date16 Dec 2005ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 26 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  • Withdrawn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
LBH
Device Class
Class II
Regulation
21 CFR Part 872.3260
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Multiple Tooth Desensitizer is a dental varnish designed to treat dentin hypersensitivity by occluding patent dentinal tubules. It is classified as a cavity varnish and functions as a therapeutic agent to alleviate tooth discomfort associated with sensitivity.

This device is supplied as a gel containing 3% potassium nitrate and 1200 ppm fluoride ion. It is intended for use in dental offices by professionals or at home by patients, applied either by brushing the affected area or using a custom tray. The device has received FDA 510(k) clearance under the Traditional pathway and is regulated under the classification code 872.3260. No sterility or MRI safety information is specified.

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Questions

AI-generated answers, 19 Sep 2026

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

  • How is the Multiple Tooth Desensitizer applied, and can it be used at home by patients?

    The Multiple Tooth Desensitizer is supplied as a gel that can be applied either by brushing the affected teeth directly or using a custom tray. It is designed for use in dental offices by professionals *and* for at-home application by patients, making it versatile for both clinical and patient-led treatment of dentin hypersensitivity.

  • What active ingredients are included in the Multiple Tooth Desensitizer, and what is their purpose?

    The gel contains 3% potassium nitrate, which helps alleviate tooth sensitivity by reducing nerve responsiveness, and 1200 ppm fluoride ion, which strengthens enamel and further protects against hypersensitivity. Together, these ingredients work to occlude exposed dentinal tubules, providing long-term relief.

  • Is the Multiple Tooth Desensitizer single-use or reusable, and are there any sterility considerations?

    The Multiple Tooth Desensitizer is intended for single-use per application—whether in a dental office or by patients at home. Since it is not sterile (no sterility claims are made), it should not be reused after initial application. For clinical use, a fresh application should be prepared for each patient.

  • What regulatory pathway was followed for FDA clearance, and how is this device classified?

    The Multiple Tooth Desensitizer received FDA 510(k) clearance under the Traditional pathway, meaning it was determined to be *substantially equivalent* to a legally marketed predicate device. It is classified under FDA product code LBH and regulated under CFR 872.3260, falling under the broader category of dental varnishes and cavity varnishes.