Cleared Traditional

K090747 - MI FLOW (GCUC-450) (FDA 510(k) Clearance)

K090747 · GC America, Inc. · Dental device

Jun 2009

Decision

82d

Days

Class 2

Risk

K090747 is an FDA 510(k) clearance for the MI FLOW (GCUC-450). 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 June 10, 2009, 82 days after receiving the submission on March 20, 2009.

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

Submission Details

510(k) Number	K090747 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 20, 2009
Decision Date	June 10, 2009
Days to Decision	82 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement