The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Calibra Cement.
| Device ID | K040906 |
| 510k Number | K040906 |
| Device Name: | CALIBRA CEMENT |
| Classification | Cement, Dental |
| Applicant | DENTSPLY INTL. 570 WEST COLLEGE AVE. York, PA 17404 |
| Contact | P. Jeffery Lehn |
| Correspondent | P. Jeffery Lehn DENTSPLY INTL. 570 WEST COLLEGE AVE. 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 | 2004-04-07 |
| Decision Date | 2004-06-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D0026075001 | K040906 | 000 |
| D0026073060 | K040906 | 000 |
| D0026072061 | K040906 | 000 |
| D0026070561 | K040906 | 000 |
| D0026070751 | K040906 | 000 |
| D0026070741 | K040906 | 000 |
| D0026070731 | K040906 | 000 |
| D0026070721 | K040906 | 000 |
| D0026070711 | K040906 | 000 |