The following data is part of a premarket notification filed by Jeneric/pentron, Inc. with the FDA for Conquest Crystal.
Device ID | K932154 |
510k Number | K932154 |
Device Name: | CONQUEST CRYSTAL |
Classification | Material, Tooth Shade, Resin |
Applicant | JENERIC/PENTRON, INC. 53 N. PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 |
Contact | Samuel Waknine |
Correspondent | Samuel Waknine JENERIC/PENTRON, INC. 53 N. PLAINS INDUSTRIAL RD. P.O. BOX 724 Wallingford, CT 06492 |
Product Code | EBF |
CFR Regulation Number | 872.3690 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-04 |
Decision Date | 1993-09-15 |