Cleared Traditional

K200798 - G-CEM ONE (FDA 510(k) Clearance)

K200798 · GC America, Inc. · Dental device

Nov 2020

Decision

243d

Days

Class 2

Risk

K200798 is an FDA 510(k) clearance for the G-CEM ONE. 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 November 24, 2020, 243 days after receiving the submission on March 26, 2020.

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

Submission Details

510(k) Number	K200798 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 26, 2020
Decision Date	November 24, 2020
Days to Decision	243 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF