The following data is part of a premarket notification filed by Jeneric/pentron, Inc. with the FDA for Prop. Conquest C&b Vlc Glaze/sealant.
Device ID | K953381 |
510k Number | K953381 |
Device Name: | PROP. CONQUEST C&B VLC GLAZE/SEALANT |
Classification | Resin, Denture, Relining, Repairing, Rebasing |
Applicant | JENERIC/PENTRON, INC. 125 N. PLAINS IND. RD. Wallingford, CT 06492 -0724 |
Contact | Joseph Macdougald |
Correspondent | Joseph Macdougald JENERIC/PENTRON, INC. 125 N. PLAINS IND. RD. Wallingford, CT 06492 -0724 |
Product Code | EBI |
CFR Regulation Number | 872.3760 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-07-19 |
Decision Date | 1995-09-27 |