The following data is part of a premarket notification filed by Jeneric/pentron, Inc. with the FDA for Tyceramic.
Device ID | K910569 |
510k Number | K910569 |
Device Name: | TYCERAMIC |
Classification | Teeth, Porcelain |
Applicant | JENERIC/PENTRON, INC. 53 N. PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 |
Contact | Arun Prasad |
Correspondent | Arun Prasad JENERIC/PENTRON, INC. 53 N. PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 |
Product Code | ELL |
CFR Regulation Number | 872.3920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-02-11 |
Decision Date | 1991-04-15 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TYCERAMIC 74125767 not registered Dead/Abandoned |
AMERICAN THERMOCRAFT CORPORATION 1990-12-24 |