The following data is part of a premarket notification filed by Ab Ardent with the FDA for Vivalloy Hr.
| Device ID | K982458 |
| 510k Number | K982458 |
| Device Name: | VIVALLOY HR |
| Classification | Alloy, Amalgam |
| Applicant | AB ARDENT 54 RIVERVIEW AVE. Tonawanda, NY 14150 -5260 |
| Contact | Clyde E Ingersoll |
| Correspondent | Clyde E Ingersoll AB ARDENT 54 RIVERVIEW AVE. Tonawanda, NY 14150 -5260 |
| Product Code | EJJ |
| CFR Regulation Number | 872.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-07-15 |
| Decision Date | 1998-08-24 |