Cleared Traditional

K020342 - UNIFIL FLOW (FDA 510(k) Clearance)

K020342 · GC America, Inc. · Dental device

Mar 2002

Decision

55d

Days

Class 2

Risk

K020342 is an FDA 510(k) clearance for the UNIFIL FLOW. 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 March 28, 2002, 55 days after receiving the submission on February 1, 2002.

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

Submission Details

510(k) Number	K020342 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 01, 2002
Decision Date	March 28, 2002
Days to Decision	55 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement