The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Biobond-crown & Bridge Ceramic Bonding.
| Device ID | K760783 |
| 510k Number | K760783 |
| Device Name: | BIOBOND-CROWN & BRIDGE CERAMIC BONDING |
| Classification | Alloy, Other Noble Metal |
| Applicant | DENTSPLY INTL. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EJS |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-10-05 |
| Decision Date | 1976-10-15 |