Cleared Abbreviated

K101710 - LUXATEMP ULTRA /STAR
(FDA 510(k) Clearance)

K101710 · Dmg USA, Inc. · Dental

Sep 2010

Decision

103d

Days

Class 2

Risk

K101710 is an FDA 510(k) clearance for the LUXATEMP ULTRA /STAR, a Crown And Bridge, Temporary, Resin (Class II — Special Controls, product code EBG), submitted by Dmg USA, Inc. (Ayer, US). The FDA issued a Cleared decision on September 28, 2010, 103 days after receiving the submission on June 17, 2010. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.

Submission Details

510(k) Number	K101710 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 17, 2010
Decision Date	September 28, 2010
Days to Decision	103 days
Submission Type	Abbreviated
Review Panel	Dental (DE)
Summary	Summary PDF