The following data is part of a premarket notification filed by Jeneric/pentron, Inc. with the FDA for Fibrekor.
Device ID | K964578 |
510k Number | K964578 |
Device Name: | FIBREKOR |
Classification | Material, Tooth Shade, Resin |
Applicant | JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 -0724 |
Contact | Murray G Gamberg |
Correspondent | Murray G Gamberg JENERIC/PENTRON, INC. 53 NORTH PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 -0724 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-11-15 |
Decision Date | 1996-12-03 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
FIBREKOR 86325180 not registered Dead/Abandoned |
Pentron Corporation 2014-07-01 |
FIBREKOR 78884620 3302191 Dead/Cancelled |
Jeneric/Pentron 2006-05-16 |
FIBREKOR 75181389 2127868 Live/Registered |
Jeneric/Pentron Incorporated 1996-10-15 |