The following data is part of a premarket notification filed by Vivadent (usa), Inc. with the FDA for Bondalcap (carboxylate).
| Device ID | K801229 |
| 510k Number | K801229 |
| Device Name: | BONDALCAP (CARBOXYLATE) |
| Classification | Cement, Dental |
| Applicant | VIVADENT (USA), INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-05-23 |
| Decision Date | 1980-06-04 |