Cleared Traditional

K935521 - GC ELITE CEMENT (FDA 510(k) Clearance)

K935521 · GC America, Inc. · Dental device

Jan 1994

Decision

49d

Days

Class 2

Risk

K935521 is an FDA 510(k) clearance for the GC ELITE CEMENT. 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 January 6, 1994, 49 days after receiving the submission on November 18, 1993.

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

Submission Details

510(k) Number	K935521 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 18, 1993
Decision Date	January 06, 1994
Days to Decision	49 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement