Cleared Traditional

TEMPORARY CROWN MATRIX BUTTONS (K900389) - FDA 510(k) Clearance

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

K900389 · Advantage Dental Products, Inc. · Dental device
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Jul 1990
Decision
165d
Days
Class 2
Risk

K900389 is an FDA 510(k) clearance for the TEMPORARY CROWN MATRIX BUTTONS. Classified as Crown And Bridge, Temporary, Resin (product code EBG), Class II - Special Controls.

Submitted by Advantage Dental Products, Inc. (Auburn Hills, US). The FDA issued a Cleared decision on July 13, 1990 after a review of 165 days - an extended review 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: 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 Advantage Dental Products, Inc. devices

Submission Details

510(k) Number K900389 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1990
Decision Date July 13, 1990
Days to Decision 165 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d slower than avg
Panel avg: 127d · This submission: 165d
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 49
Devices cleared under the same product code (EBG) and FDA review panel - the closest regulatory comparables to K900389.
3M QUIKPLUS SYSTEM
K970168 · 3M Company · Feb 1997
3M TEMPCARE LIGHT CURE TEMPORARY SYSTEM
K944981 · 3M Company · Dec 1994
3M TEMPORARY CROWN & BRIDGE MATERIAL
K935041 · 3M Company · Jan 1994
INTEGRITY
K853052 · Dentsply Intl. · Aug 1985
MYERSONS SPEC. CROWN & BRIDGE RESIN
K771602 · Howmedica Corp. · Aug 1977