The following data is part of a premarket notification filed by Aalba Dent, Inc. with the FDA for Alfalloy.
| Device ID | K972534 |
| 510k Number | K972534 |
| Device Name: | ALFALLOY |
| Classification | Alloy, Other Noble Metal |
| Applicant | AALBA DENT, INC. 400 WATT DR. Cordelia, CA 94534 |
| Contact | Vincent M Benetti |
| Correspondent | Vincent M Benetti AALBA DENT, INC. 400 WATT DR. Cordelia, CA 94534 |
| Product Code | EJS |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-07 |
| Decision Date | 1997-09-05 |