Cleared Traditional

K980695 - FUJI I (FDA 510(k) Clearance)

K980695 · GC America, Inc. · Dental device

Apr 1998

Decision

49d

Days

Class 2

Risk

K980695 is an FDA 510(k) clearance for the FUJI I. 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 April 13, 1998, 49 days after receiving the submission on February 23, 1998.

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

Submission Details

510(k) Number	K980695 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 23, 1998
Decision Date	April 13, 1998
Days to Decision	49 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement