Cleared Traditional

K001730 - GC FUJICEM (FDA 510(k) Clearance)

K001730 · GC America, Inc. · Dental device

Jul 2000

Decision

40d

Days

Class 2

Risk

K001730 is an FDA 510(k) clearance for the GC FUJICEM. 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 July 17, 2000, 40 days after receiving the submission on June 7, 2000.

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

Submission Details

510(k) Number	K001730 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 07, 2000
Decision Date	July 17, 2000
Days to Decision	40 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement