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) Official FDA 510(k) Summary (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.

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
25d faster than avg
Panel avg: 128d · 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 174
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K101710.
ENA TEMP AND ENAMEL PLUS TEMP (TWO DIFFERENT PROPRIETARY NAMES FOR THE SAME PRODUCT)
K103474 · Micerium S.P.A. · Feb 2011
TURBO TEMP 3
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VIPI BLOCK
K102341 · Vipi Industria,Comercio,Exportacao E Importacao DE · Dec 2010
DIRECT CROWN NATURAL 1
K101814 · Candulor USA, Inc. · Sep 2010
TELIO CAD
K093708 · Ivoclar Vivadent, Inc. · Mar 2010
MIZZY EXPRESS
K093380 · Mycone Dental Supply Co., Inc. · Mar 2010