510(k) K945200 ยท KOO Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt
FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES
| Applicant | Procter & Gamble Co., Cincinnati OH, US |
| Decision | Substantially Equivalent, Nov 30, 1994 |
| Received | Oct 25, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945200
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2023 | Family Dollar Stores, Llc. FIXODENT ORG CREAM 2.4OZ, SKU 906018
FIXODENT ADH CREAM WITH SCOPE 2OZ, SKU 906402
FIXODENT ORG CREAM TRAVEL .75OZ, SKU 901239 Open, Classified |
KOO | None listed |
| Aug 17, 2022 | Family Dollar Stores, Llc. FIXODENT ORG CREAM 2.4OZ, SKU 906018
FIXODENT ORG CREAM TRAVEL .75OZ, SKU 901239 Open, Classified |
KOO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.