Cleared Traditional

K001518 - GRADIA (FDA 510(k) Clearance)

K001518 · GC America, Inc. · Dental device

Jul 2000

Decision

50d

Days

Class 2

Risk

K001518 is an FDA 510(k) clearance for the GRADIA. 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 July 5, 2000, 50 days after receiving the submission on May 16, 2000.

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

Submission Details

510(k) Number	K001518 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 16, 2000
Decision Date	July 05, 2000
Days to Decision	50 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement