Cleared Traditional

K082171 - GRADIA CORE (FDA 510(k) Clearance)

K082171 · GC America, Inc. · Dental device

Oct 2008

Decision

90d

Days

Class 2

Risk

K082171 is an FDA 510(k) clearance for the GRADIA CORE. 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 October 30, 2008, 90 days after receiving the submission on August 1, 2008.

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

Submission Details

510(k) Number	K082171 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 01, 2008
Decision Date	October 30, 2008
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement