Cleared Traditional

LUXATEMP AUTOMIX (K924830) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K924830 · Dmg Chemisch Pharmazeutische Fabrik GmbH · Dental device
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Apr 1994
Decision
581d
Days
Class 2
Risk

K924830 is an FDA 510(k) clearance for the LUXATEMP AUTOMIX. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Dmg Chemisch Pharmazeutische Fabrik GmbH (Germany, GR). The FDA issued a Cleared decision on April 29, 1994 after a review of 581 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Dmg Chemisch Pharmazeutische Fabrik GmbH devices

Submission Details

510(k) Number K924830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1992
Decision Date April 29, 1994
Days to Decision 581 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
454d slower than avg
Panel avg: 127d · This submission: 581d
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 69
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K924830.
BELLEGLASHP
K955331 · Sybron Dental Specialties, Inc. · Jan 1996
3M TEMPCARE LIGHT CURE TEMPORARY SYSTEM
K944981 · 3M Company · Dec 1994
GC PATTERN RESIN
K942670 · GC America, Inc. · Oct 1994
STRUCTUR 2
K941124 · Voco GmbH · Apr 1994
GC TEMPRON
K935960 · GC America, Inc. · Mar 1994
3M TEMPORARY CROWN & BRIDGE MATERIAL
K935041 · 3M Company · Jan 1994