The following data is part of a premarket notification filed by Centrix, Inc. with the FDA for D/sense-t.
Device ID | K973285 |
510k Number | K973285 |
Device Name: | D/SENSE-T |
Classification | Agent, Tooth Bonding, Resin |
Applicant | CENTRIX, INC. 770 RIVER RD. Shelton, CT 06484 -5458 |
Contact | John Discko |
Correspondent | John Discko CENTRIX, INC. 770 RIVER RD. Shelton, CT 06484 -5458 |
Product Code | KLE |
CFR Regulation Number | 872.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-09-02 |
Decision Date | 1998-02-25 |