Cleared Traditional

K993973 - FUJI II LC CAPSULE (FDA 510(k) Clearance)

K993973 · GC America, Inc. · Dental device

Jan 2000

Decision

49d

Days

Class 2

Risk

K993973 is an FDA 510(k) clearance for the FUJI II LC CAPSULE. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on January 11, 2000, 49 days after receiving the submission on November 23, 1999.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number	K993973 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 23, 1999
Decision Date	January 11, 2000
Days to Decision	49 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement