The following data is part of a premarket notification filed by Foremost Dental Mfg., Inc. with the FDA for Tempo Cem (multiple).
| Device ID | K970775 |
| 510k Number | K970775 |
| Device Name: | TEMPO CEM (MULTIPLE) |
| Classification | Cement, Dental |
| Applicant | FOREMOST DENTAL MFG., INC. 242 - SOUTH DEAN ST. Englewood, NJ 07631 |
| Contact | D.t. Wolf |
| Correspondent | D.t. Wolf FOREMOST DENTAL MFG., INC. 242 - SOUTH DEAN ST. Englewood, NJ 07631 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-04 |
| Decision Date | 1997-06-03 |