Cleared Traditional

K946100 - FUJI DUET (FDA 510(k) Clearance)

K946100 · GC America, Inc. · Dental device

Jan 1995

Decision

37d

Days

Class 2

Risk

K946100 is an FDA 510(k) clearance for the FUJI DUET. 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 20, 1995, 37 days after receiving the submission on December 14, 1994.

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

Submission Details

510(k) Number	K946100 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 14, 1994
Decision Date	January 20, 1995
Days to Decision	37 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement