Cleared Traditional

K925032 - 3M VITREMER TRI-CURE GLASS IONOMER SYSTEM

K925032 is the FDA 510(k) clearance for 3M VITREMER TRI-CURE GLASS IONOMER SYSTEM by 3M Company. It is a Class 2 Dental device (product code EMA) cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K925032 · 3M Company · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1992
Decision
79d
Days
Class 2
Risk

K925032 is an FDA 510(k) clearance for the 3M VITREMER TRI-CURE GLASS IONOMER SYSTEM. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by 3M Company (Cottae Grove, US). The FDA issued a Cleared decision on December 23, 1992 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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.

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Submission Details

510(k) Number K925032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 05, 1992
Decision Date December 23, 1992
Days to Decision 79 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
48d faster than avg
Panel avg: 127d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 254
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K925032.
CHAMELEON LIGHT/CHEMICAL CURE GLASS IONOMER
K930455 · Voco GmbH · Apr 1993
BIFIX DENTAL CEMENT
K926458 · Voco GmbH · Mar 1993
VITA CEREC DUO CEMENT
K925713 · Vident · Feb 1993
TYPE 1 DENTAL CEMENT
K921173 · Centrix, Inc. · Nov 1992
VENEER CEMENT
K923328 · Dentsply Intl. · Sep 1992
TEMPIT-E
K922638 · Centrix, Inc. · Aug 1992