The following data is part of a premarket notification filed by Metalor Dental Usa Corp. with the FDA for Aurofilm 2000.
| Device ID | K973372 |
| 510k Number | K973372 |
| Device Name: | AUROFILM 2000 |
| Classification | Alloy, Gold-based Noble Metal |
| Applicant | METALOR DENTAL USA CORP. 255 JOHN L. DIETSCH BLVD. North Attleborough, MA 02761 |
| Contact | Kenneth A Putney |
| Correspondent | Kenneth A Putney METALOR DENTAL USA CORP. 255 JOHN L. DIETSCH BLVD. North Attleborough, MA 02761 |
| Product Code | EJT |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-08 |
| Decision Date | 1997-11-26 |