The following data is part of a premarket notification filed by Matech, Inc. with the FDA for Ceradium Non-precious Ceramic Alloy.
Device ID | K992705 |
510k Number | K992705 |
Device Name: | CERADIUM 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 | 1999-08-11 |
Decision Date | 1999-09-22 |