The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Temporary Dental Cement.
| Device ID | K895487 |
| 510k Number | K895487 |
| Device Name: | TEMPORARY DENTAL CEMENT |
| Classification | Cement, Dental |
| Applicant | DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York, PA 17405 |
| Contact | John O Semmelman |
| Correspondent | John O Semmelman DENTSPLY INTL. 570 WEST COLLEGE AVE. P.O. BOX 872 York, PA 17405 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-09-01 |
| Decision Date | 1990-04-02 |