The following data is part of a premarket notification filed by Centrix, Inc. with the FDA for D/sense Ii (green-or) Dentin Desensitizer.
Device ID | K992629 |
510k Number | K992629 |
Device Name: | D/SENSE II (GREEN-OR) DENTIN DESENSITIZER |
Classification | Varnish, Cavity |
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 | LBH |
CFR Regulation Number | 872.3260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-07-28 |
Decision Date | 1999-10-22 |