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Super Strength Denture Adhesive Cream

by Teledyne Getz

510(k) K901938

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 NumberK901938 Date6 Jun 1990ClearedStatusActive

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  • Withdrawn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
KOB
Device Class
Class II
Regulation
21 CFR Part 876.5090
Advisory Committee
Gastroenterology, Urology
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.

This device is a Denture Adhesive Cream, designed to provide secure attachment of dentures to the oral mucosa. It is classified under FDA regulation 876.5090 and falls under the product code KOB, intended for use in dental applications to enhance retention and comfort for denture wearers.

The cream is supplied as a non-sterile, single-use product and is intended for use in non-clinical settings, such as the home. It is not intended for MRI use and must be stored in a cool, dry place. Authorized under FDA 510(k) clearance K901938 with a decision of Substantially Equivalent, it adheres to regulatory standards for dental adhesives.

Other devices from Teledyne Getz

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.

  • Is this denture adhesive cream suitable for use in a clinical setting like a dental office, or is it meant for home use only?

    This product is explicitly designed for non-clinical use, such as at home. The manufacturer specifies it is intended for secure attachment of dentures in everyday settings, not for professional dental procedures or office environments.

  • How should I store this denture adhesive cream to maintain its effectiveness?

    The cream must be kept in a cool, dry place to preserve its integrity. Avoid exposure to moisture, heat, or direct sunlight, as these conditions could degrade its adhesive properties over time.

  • Is this adhesive cream reusable, or is it intended for single-use only?

    This product is single-use only, meaning each tube should be discarded after application. The manufacturer’s description explicitly states it is non-sterile and not intended for reuse, which aligns with typical home-use dental adhesives.

  • What sizes or models of this denture adhesive cream are available?

    The provided data does not specify exact tube sizes or model variations (e.g., tube volume or packaging differences). For precise sizing details, you would need to consult the manufacturer’s current product catalog or packaging.

  • Can this adhesive be used safely with MRI procedures, or should it be avoided?

    The manufacturer explicitly states this adhesive is not intended for MRI use. If MRI compatibility is required, alternative products should be considered to avoid potential risks or interference.