The following data is part of a premarket notification filed by Ardent Production Development with the FDA for Ardent Non Gamma-2 70.
| Device ID | K964192 |
| 510k Number | K964192 |
| Device Name: | ARDENT NON GAMMA-2 70 |
| Classification | Alloy, Amalgam |
| Applicant | ARDENT PRODUCTION DEVELOPMENT 54 RIVERVIEW AVE. Tonawanda, NY 14150 -5260 |
| Contact | Clyde E Ingersoll |
| Correspondent | Clyde E Ingersoll ARDENT PRODUCTION DEVELOPMENT 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 | 1996-10-17 |
| Decision Date | 1997-01-06 |