Cleared Traditional

K961448 - FUJI IX GP (FDA 510(k) Clearance)

K961448 · GC America, Inc. · Dental device

Jul 1996

Decision

83d

Days

Class 2

Risk

K961448 is an FDA 510(k) clearance for the FUJI IX GP. 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 8, 1996, 83 days after receiving the submission on April 16, 1996.

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

Submission Details

510(k) Number	K961448 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 16, 1996
Decision Date	July 08, 1996
Days to Decision	83 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement