The following data is part of a premarket notification filed by Austenal Dental, Inc. with the FDA for Ncm - Alpha Alloy (dental Bake-on Alloy).
| Device ID | K860217 |
| 510k Number | K860217 |
| Device Name: | NCM - ALPHA ALLOY (DENTAL BAKE-ON ALLOY) |
| Classification | Alloy, Metal, Base |
| Applicant | AUSTENAL DENTAL, INC. 5101 S. KEELER AVE. Chicago, IL 60632 |
| Contact | Ronald Dudek |
| Correspondent | Ronald Dudek AUSTENAL DENTAL, INC. 5101 S. KEELER AVE. Chicago, IL 60632 |
| Product Code | EJH |
| CFR Regulation Number | 872.3710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-22 |
| Decision Date | 1986-03-17 |