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GLUMA Desensitizer Power Gel

by Heraeus Kulzer, LLC 510(k)

Active United States

510(k) K093575

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK093575 Date5 Mar 2010ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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, 6 Oct 2026

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

GLUMA Desensitizer Power Gel is a dental varnish device classified as substantially equivalent to a predicate device under FDA 510(k) clearance K093575. It is indicated for use in dental applications to address tooth hypersensitivity. The device is supplied as a green-colored gel for controlled and precise application.

It is intended for use in dental settings and is designed for easy application, detection, and rinsing. The product is manufactured by Heraeus Kulzer, LLC and distributed under traditional 510(k) clearance. Storage and handling should follow manufacturer instructions as implied by its dental varnish classification.

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