The following data is part of a premarket notification filed by Procter & Gamble Co. with the FDA for Fixodent, Fixodent Fresh, Fasteeth And Extra Hold Fasteeth Denture Adhesivces.
| Device ID | K945200 |
| 510k Number | K945200 |
| Device Name: | FIXODENT, FIXODENT FRESH, FASTEETH AND EXTRA HOLD FASTEETH DENTURE ADHESIVCES |
| Classification | Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-sodium Double Salt |
| Applicant | PROCTER & GAMBLE CO. SHARON WOODS TECHNICAL CENTTER 11450 GROOMS ROAD Cincinnati, OH 45242 -1434 |
| Contact | Randall A Stolt |
| Correspondent | Randall A Stolt PROCTER & GAMBLE CO. SHARON WOODS TECHNICAL CENTTER 11450 GROOMS ROAD Cincinnati, OH 45242 -1434 |
| Product Code | KOO |
| CFR Regulation Number | 872.3490 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-25 |
| Decision Date | 1994-11-30 |