The following data is part of a premarket notification filed by Matech, Inc. with the FDA for Hi Bond Non-precious Ceramic Alloy.
| Device ID | K992881 |
| 510k Number | K992881 |
| Device Name: | HI BOND NON-PRECIOUS CERAMIC ALLOY |
| Classification | Alloy, Metal, Base |
| Applicant | MATECH, INC. 13010 SAN FERNANDO RD. Sylmar, CA 91342 |
| Contact | Paul L Saxton |
| Correspondent | Paul L Saxton MATECH, INC. 13010 SAN FERNANDO RD. Sylmar, CA 91342 |
| Product Code | EJH |
| CFR Regulation Number | 872.3710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-26 |
| Decision Date | 1999-11-19 |