The following data is part of a premarket notification filed by Majestic Drug Co., Inc. with the FDA for Dentemp One Step.
| Device ID | K964773 |
| 510k Number | K964773 |
| Device Name: | DENTEMP ONE STEP |
| Classification | Cement, Dental |
| Applicant | MAJESTIC DRUG CO., INC. 711-717 EAST 134TH ST. Bronx, NY 10454 |
| Contact | Larry Fishman |
| Correspondent | Larry Fishman MAJESTIC DRUG CO., INC. 711-717 EAST 134TH ST. Bronx, NY 10454 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-27 |
| Decision Date | 1997-02-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00372494101885 | K964773 | 000 |
| 00372494101700 | K964773 | 000 |