The following data is part of a premarket notification filed by Vivadent (usa), Inc. with the FDA for Amalcap-non-gamma-2.
| Device ID | K790874 |
| 510k Number | K790874 |
| Device Name: | AMALCAP-NON-GAMMA-2 |
| Classification | Alloy, Amalgam |
| Applicant | VIVADENT (USA), INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EJJ |
| CFR Regulation Number | 872.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-05-07 |
| Decision Date | 1979-06-05 |