The following data is part of a premarket notification filed by Austenal Dental, Inc. with the FDA for A-sp Alloy (silver-palladium Crown & Bridge Alloy).
| Device ID | K864826 |
| 510k Number | K864826 |
| Device Name: | A-SP ALLOY (SILVER-PALLADIUM CROWN & BRIDGE ALLOY) |
| Classification | Alloy, Metal, Base |
| Applicant | AUSTENAL DENTAL, INC. 5101 S. KEELER AVE. Chicago, IL 60632 |
| Contact | Mark Wojtulewicz |
| Correspondent | Mark Wojtulewicz 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 | 1986-12-09 |
| Decision Date | 1987-02-10 |