Cleared Traditional

K003034 - COLTENE AURA COMPOMER RESTORATIVE SYSTEM
(FDA 510(k) Clearance)

K003034 · Coltene/Whaledent, Inc. · Dental device

Nov 2000

Decision

63d

Days

Class 2

Risk

K003034 is an FDA 510(k) clearance for the COLTENE AURA COMPOMER RESTORATIVE SYSTEM. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).

Submitted by Coltene/Whaledent, Inc. (Mahwah, US). The FDA issued a Cleared decision on November 30, 2000, 63 days after receiving the submission on September 28, 2000.

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

Submission Details

510(k) Number	K003034 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 28, 2000
Decision Date	November 30, 2000
Days to Decision	63 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement