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Fixodent, Fixodent Fresh, Fasteeth and Extra Hold Fasteeth Denture Adhesivces

by Procter & Gamble Co.

510(k) K945200

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK945200 Date30 Nov 1994ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-0263-2024 FDA Class II initiated 4 Oct 2023

    Products were stored outside of labeled temperature requirements.

    • Ongoing Z-1538-2022 FDA Class II initiated 23 Jun 2022

    Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.

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  • Withdrawn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
KOO
Device Class
Class I
Regulation
21 CFR Part 872.3490
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

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