Cleared Traditional

K033808 - GRADIA GUM (FDA 510(k) Clearance)

K033808 · GC America, Inc. · Dental device

Feb 2004

Decision

56d

Days

Class 2

Risk

K033808 is an FDA 510(k) clearance for the GRADIA GUM. 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 February 2, 2004, 56 days after receiving the submission on December 8, 2003.

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

Submission Details

510(k) Number	K033808 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 08, 2003
Decision Date	February 02, 2004
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement