Cleared Traditional

K033227 - LUXAFORM PLUS

K033227 is an FDA 510(k) clearance for LUXAFORM PLUS, manufactured by Dmg USA, Inc.. The device is a Class 2 Dental device with product code EBG cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K033227 · Dmg USA, Inc. · Dental device
Download Printable Device Report (PDF)
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Jan 2004
Decision
102d
Days
Class 2
Risk

K033227 is an FDA 510(k) clearance for the LUXAFORM PLUS. 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 16, 2004 after a review of 102 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Dmg USA, Inc. devices

FDA 510(k) Submission Details - K033227

510(k) Number K033227 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2003
Decision Date January 16, 2004
Days to Decision 102 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
25d faster than avg
Panel avg: 127d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 159
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K033227.
SR ADORO
K040951 · Ivoclar Vivadent, Inc. · May 2004
COOL TEMP NATURAL
K041098 · Coltene AG · May 2004
STRUCTUR 2 SC
K040769 · Voco GmbH · Apr 2004
LEXATITE QUICK ACRYLIC
K033432 · Imtec Corp. · Jan 2004
PROTEMP 3 GARANT
K033022 · 3M Espe AG Dental Products · Nov 2003
FILL-IN
K031476 · Sybron Dental Specialties, Inc. · Jul 2003