Cleared Traditional

K935961 - GC FUJI COAT LC (FDA 510(k) Clearance)

K935961 · GC America, Inc. · Dental device

Mar 1994

Decision

87d

Days

Class 2

Risk

K935961 is an FDA 510(k) clearance for the GC FUJI COAT LC. This device is classified as a Agent, Tooth Bonding, Resin (Class II - Special Controls, product code KLE).

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on March 10, 1994, 87 days after receiving the submission on December 13, 1993.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number	K935961 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 13, 1993
Decision Date	March 10, 1994
Days to Decision	87 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement