Cleared Traditional

D-SENSE

K955279 · Centrix, Inc. · Dental
Dec 1995
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K955279 is an FDA 510(k) clearance for the D-SENSE, 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 December 28, 1995, 42 days after receiving the submission on November 16, 1995. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K955279 FDA.gov
FDA Decision Cleared SESE
Date Received November 16, 1995
Decision Date December 28, 1995
Days to Decision 42 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