The following data is part of a premarket notification filed by Sultan Chemists, Inc. with the FDA for Dinabase (tm).
| Device ID | K971138 |
| 510k Number | K971138 |
| Device Name: | DINABASE (TM) |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | SULTAN CHEMISTS, INC. 85 WEST FOREST AVE. Englewood, NJ 07631 |
| Contact | Les Heimann |
| Correspondent | Les Heimann SULTAN CHEMISTS, INC. 85 WEST FOREST AVE. Englewood, NJ 07631 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-28 |
| Decision Date | 1997-07-21 |