Cleared Traditional

K120243 - GAM-200 (FDA 510(k) Clearance)

K120243 · GC America, Inc. · Dental device

Jun 2012

Decision

152d

Days

Class 2

Risk

K120243 is an FDA 510(k) clearance for the GAM-200. 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 June 27, 2012, 152 days after receiving the submission on January 27, 2012.

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

Submission Details

510(k) Number	K120243 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 27, 2012
Decision Date	June 27, 2012
Days to Decision	152 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF