Cleared Traditional

K070190 - GRADIA DIRECT X (FDA 510(k) Clearance)

K070190 · GC America, Inc. · Dental device

Mar 2007

Decision

49d

Days

Class 2

Risk

K070190 is an FDA 510(k) clearance for the GRADIA DIRECT X. 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 12, 2007, 49 days after receiving the submission on January 22, 2007.

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

Submission Details

510(k) Number	K070190 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 22, 2007
Decision Date	March 12, 2007
Days to Decision	49 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement