Cleared Abbreviated

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

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

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

Submission Details

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
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 127d · This submission: 103d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 69
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K101710.
TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT
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MSN-006
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STRUCTUR 3
K120779 · Voco GmbH · Jun 2012
TEMPORARY C&B COMPOSITE
K091894 · Voco GmbH · Jul 2009
UNIFAST III
K073106 · GC America, Inc. · Apr 2008
STRUCTUR 2 SC
K040769 · Voco GmbH · Apr 2004