# K945200: Fixodent, Fixodent Fresh, Fasteeth and Extra Hold Fasteeth Denture Adhesivces

- Pathway: 510(k) (Traditional)
- Applicant: Procter & Gamble Co.
- Decided: Nov 30, 1994 after 36 days
- Product code: KOO (Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt)
- Device class: 1
- Regulation: 21 CFR 872.3490
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Oct 4, 2023 · Class II · Z-0263-2024: Products were stored outside of labeled temperature requirements.
- Jun 23, 2022 · Class II · Z-1538-2022: Affected product was not appropriately stored in temperature-controlled areas between April 30, 2022 - June 10, 2022.

Source page: https://510kreport.com/device/K945200
Methodology: https://510kreport.com/methodology