The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Integrity Temporary Cement.
| Device ID | K040895 |
| 510k Number | K040895 |
| Device Name: | INTEGRITY TEMPORARY CEMENT |
| Classification | Cement, Dental |
| Applicant | DENTSPLY INTL. 221 WEST PHILADELPHIA STREET SUITE 60 York, PA 17404 |
| Contact | P. Jeffery Lehn |
| Correspondent | P. Jeffery Lehn DENTSPLY INTL. 221 WEST PHILADELPHIA STREET SUITE 60 York, PA 17404 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-06 |
| Decision Date | 2004-05-21 |
| Summary: | summary |