Cleared Traditional

K042348 - GRADIA DIRECT LOFLO (FDA 510(k) Clearance)

K042348 · GC America, Inc. · Dental device

Nov 2004

Decision

80d

Days

Class 2

Risk

K042348 is an FDA 510(k) clearance for the GRADIA DIRECT LOFLO. 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 November 18, 2004, 80 days after receiving the submission on August 30, 2004.

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

Submission Details

510(k) Number	K042348 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 30, 2004
Decision Date	November 18, 2004
Days to Decision	80 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement