Cleared Traditional

DENTINSENSE B/C

K965138 · Centrix, Inc. · Dental
Feb 1997
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K965138 is an FDA 510(k) clearance for the DENTINSENSE B/C, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on February 14, 1997, 53 days after receiving the submission on December 23, 1996. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K965138 FDA.gov
FDA Decision Cleared SESE
Date Received December 23, 1996
Decision Date February 14, 1997
Days to Decision 53 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code KLE — Agent, Tooth Bonding, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3200