Cleared Traditional

K071674 - GC-ZIRCONIA (FDA 510(k) Clearance)

K071674 · GC America, Inc. · Dental device

Aug 2007

Decision

51d

Days

Class 2

Risk

K071674 is an FDA 510(k) clearance for the GC-ZIRCONIA. 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 August 9, 2007, 51 days after receiving the submission on June 19, 2007.

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

Submission Details

510(k) Number	K071674 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 19, 2007
Decision Date	August 09, 2007
Days to Decision	51 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement