Cleared Traditional

TEAM ETCH

K963311 · Centrix, Inc. · Dental
Oct 1996
Decision
46d
Days
Class 2
Risk

About This 510(k) Submission

K963311 is an FDA 510(k) clearance for the TEAM ETCH, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on October 7, 1996, 46 days after receiving the submission on August 22, 1996. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K963311 FDA.gov
FDA Decision Cleared SESE
Date Received August 22, 1996
Decision Date October 07, 1996
Days to Decision 46 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690