Cleared Traditional

K963311 - TEAM ETCH (FDA 510(k) Clearance)

K963311 · Centrix, Inc. · Dental device

Oct 1996

Decision

46d

Days

Class 2

Risk

K963311 is an FDA 510(k) clearance for the TEAM ETCH. This device is classified as 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 FDA review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number	K963311 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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