Cleared Traditional

K070840 - GVC-100 (FDA 510(k) Clearance)

K070840 · GC America, Inc. · Dental device

May 2007

Decision

49d

Days

Class 2

Risk

K070840 is an FDA 510(k) clearance for the GVC-100. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on May 15, 2007, 49 days after receiving the submission on March 27, 2007.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number	K070840 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 27, 2007
Decision Date	May 15, 2007
Days to Decision	49 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement