Cleared Traditional

K013674 - LUXATEMP/LUXATEMP SOLAR/INSTATEMP

K013674 is the FDA 510(k) clearance for LUXATEMP/LUXATEMP SOLAR/INSTATEMP by Dmg USA, Inc.. It is a Class 2 Dental device (product code EBG) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K013674 · Dmg USA, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2002
Decision
78d
Days
Class 2
Risk

K013674 is an FDA 510(k) clearance for the LUXATEMP/LUXATEMP SOLAR/INSTATEMP. 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 January 24, 2002 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3770 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dmg USA, Inc. devices

Submission Details

510(k) Number K013674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 07, 2001
Decision Date January 24, 2002
Days to Decision 78 days
Submission Type Traditional
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
49d faster than avg
Panel avg: 127d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 109
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K013674.
SR IVOCRON
K013869 · Ivoclar Vivadent, Inc. · Aug 2002
TEMPORARY CROWN AND BRIDGE MATERIAL
K020157 · J. Morita USA, Inc. · Mar 2002
TEMPFIL
K013895 · Sybron Dental Specialties, Inc. · Feb 2002
LC TEMPORARY FILLING
K012360 · Parkell, Inc. · Sep 2001
PATTERN RESIN
K003817 · GC America, Inc. · Jan 2001
FERMIT PLUS
K003374 · Ivoclar North America, Inc. · Dec 2000