Cleared Abbreviated

K101710 - LUXATEMP ULTRA /STAR

K101710 is an FDA 510(k) clearance for LUXATEMP ULTRA /STAR, manufactured by Dmg USA, Inc.. The device is a Class 2 Dental device with product code EBG cleared through the Abbreviated 510(k) pathway after a 103-day FDA review.

K101710 · Dmg USA, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2010
Decision
103d
Days
Class 2
Risk

K101710 is an FDA 510(k) clearance for the LUXATEMP ULTRA /STAR. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Dmg USA, Inc. (Ayer, US). The FDA issued a Cleared decision on September 28, 2010 after a review of 103 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Dmg USA, Inc. devices

FDA 510(k) Submission Details - K101710

510(k) Number K101710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 127d · This submission: 103d
Pathway characteristics
Standards-based clearance path.

EBG Device Classification - Class 2, Special Controls

Product Code EBG Crown And Bridge, Temporary, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3770
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EBG Crown And Bridge, Temporary, Resin

All 117
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K101710.
TEMPFLEX
K110747 · Kerr Corporation · Jun 2011
PRO-V COAT
K103514 · Bisco, Inc. · May 2011
TELIO CS INLAY & TELIO CS ONLAY
K103379 · Ivoclar Vivadent, Inc. · Feb 2011
TELIO CAD
K093708 · Ivoclar Vivadent, Inc. · Mar 2010
TEMPORARY C&B COMPOSITE
K091894 · Voco GmbH · Jul 2009
PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL
K081810 · Pulpdent Corporation · Sep 2008