Cleared Traditional

K040567 - GC INITIAL MC, AL AND LF (FDA 510(k) Clearance)

K040567 · GC America, Inc. · Dental device

Apr 2004

Decision

49d

Days

Class 2

Risk

K040567 is an FDA 510(k) clearance for the GC INITIAL MC, AL AND LF. This device is classified as a Powder, Porcelain (Class II - Special Controls, product code EIH).

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on April 22, 2004, 49 days after receiving the submission on March 4, 2004.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number	K040567 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 04, 2004
Decision Date	April 22, 2004
Days to Decision	49 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF