Cleared Traditional

K951555 - FUJI IX (FDA 510(k) Clearance)

K951555 · GC America, Inc. · Dental device

May 1995

Decision

49d

Days

Class 2

Risk

K951555 is an FDA 510(k) clearance for the FUJI IX. 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 May 23, 1995, 49 days after receiving the submission on April 4, 1995.

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

Submission Details

510(k) Number	K951555 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 04, 1995
Decision Date	May 23, 1995
Days to Decision	49 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement