The following data is part of a premarket notification filed by Stiefel Research Institute, Inc. with the FDA for Steadfast Denture Adhesive Powder.
| Device ID | K910216 |
| 510k Number | K910216 |
| Device Name: | STEADFAST DENTURE ADHESIVE POWDER |
| Classification | Adhesive, Denture, Acacia And Karaya With Sodium Borate |
| 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 | KOM |
| CFR Regulation Number | 872.3400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-17 |
| Decision Date | 1991-03-29 |