Cleared Traditional

K021038 - GC ELITE CEMENT 100 (FDA 510(k) Clearance)

K021038 · GC America, Inc. · Dental device

May 2002

Decision

32d

Days

Class 2

Risk

K021038 is an FDA 510(k) clearance for the GC ELITE CEMENT 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 3, 2002, 32 days after receiving the submission on April 1, 2002.

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

Submission Details

510(k) Number	K021038 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 01, 2002
Decision Date	May 03, 2002
Days to Decision	32 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement