Cleared Traditional

K023814 - GRADIA DIRECT (FDA 510(k) Clearance)

K023814 · GC America, Inc. · Dental device

Jan 2003

Decision

76d

Days

Class 2

Risk

K023814 is an FDA 510(k) clearance for the GRADIA DIRECT. 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 January 30, 2003, 76 days after receiving the submission on November 15, 2002.

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

Submission Details

510(k) Number	K023814 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 15, 2002
Decision Date	January 30, 2003
Days to Decision	76 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement