Cleared Traditional

D/SENSE-T

K973285 · Centrix, Inc. · Dental
Feb 1998
Decision
176d
Days
Class 2
Risk

About This 510(k) Submission

K973285 is an FDA 510(k) clearance for the D/SENSE-T, 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 25, 1998, 176 days after receiving the submission on September 2, 1997. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K973285 FDA.gov
FDA Decision Cleared SESE
Date Received September 02, 1997
Decision Date February 25, 1998
Days to Decision 176 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