The following data is part of a premarket notification filed by Austenal Dental, Inc. with the FDA for Palladium Based Dent Alloys/porcelain Metal Restor.
| Device ID | K862856 |
| 510k Number | K862856 |
| Device Name: | PALLADIUM BASED DENT ALLOYS/PORCELAIN METAL RESTOR |
| Classification | Alloy, Other Noble Metal |
| 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 | EJS |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-07-29 |
| Decision Date | 1986-08-26 |