Cleared Abbreviated

K012307 - LUXACORE/LUXACORE DUAL
(FDA 510(k) Clearance)

K012307 · Dmg USA, Inc. · Dental device

Aug 2001

Decision

31d

Days

Class 2

Risk

K012307 is an FDA 510(k) clearance for the LUXACORE/LUXACORE DUAL. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).

Submitted by Dmg USA, Inc. (Ayer, US). The FDA issued a Cleared decision on August 23, 2001, 31 days after receiving the submission on July 23, 2001.

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

Submission Details

510(k) Number	K012307 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 23, 2001
Decision Date	August 23, 2001
Days to Decision	31 days
Submission Type	Abbreviated
Review Panel	Dental (DE)
Summary	Summary PDF