The following data is part of a premarket notification filed by Metalor Dental Usa Corp. with the FDA for Aurofilm Np.
| Device ID | K003387 |
| 510k Number | K003387 |
| Device Name: | AUROFILM NP |
| Classification | Alloy, Metal, Base |
| 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 | EJH |
| CFR Regulation Number | 872.3710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-31 |
| Decision Date | 2001-01-09 |