The following data is part of a premarket notification filed by Stiefel Research Institute, Inc. with the FDA for Steadfast Denture Adhesive Cream.
| Device ID | K895818 |
| 510k Number | K895818 |
| Device Name: | STEADFAST DENTURE ADHESIVE CREAM |
| Classification | Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-sodium |
| Applicant | STIEFEL RESEARCH INSTITUTE, INC. Oak Hill, NY 12460 |
| Contact | Carr, Jr |
| Correspondent | Carr, Jr STIEFEL RESEARCH INSTITUTE, INC. Oak Hill, NY 12460 |
| Product Code | KOT |
| CFR Regulation Number | 872.3490 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-29 |
| Decision Date | 1990-04-03 |