Cleared Traditional

K073283 - GC GAM-100 (FDA 510(k) Clearance)

K073283 · GC America, Inc. · Dental device

Feb 2008

Decision

91d

Days

Class 2

Risk

K073283 is an FDA 510(k) clearance for the GC GAM-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 February 20, 2008, 91 days after receiving the submission on November 21, 2007.

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

Submission Details

510(k) Number	K073283 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 21, 2007
Decision Date	February 20, 2008
Days to Decision	91 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement