Cleared Traditional

K926458 - BIFIX DENTAL CEMENT

K926458 is an FDA 510(k) clearance for BIFIX DENTAL CEMENT, manufactured by Voco GmbH. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K926458 · Voco GmbH · Dental device
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Mar 1993
Decision
97d
Days
Class 2
Risk

K926458 is an FDA 510(k) clearance for the BIFIX DENTAL CEMENT. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Voco GmbH (St Louis, US). The FDA issued a Cleared decision on March 31, 1993 after a review of 97 days - within the typical 510(k) review window.

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: 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 Voco GmbH devices

FDA 510(k) Submission Details - K926458

510(k) Number K926458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1992
Decision Date March 31, 1993
Days to Decision 97 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
30d faster than avg
Panel avg: 127d · This submission: 97d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EMA Device Classification - Class 2, Special Controls

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 421
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K926458.
MULTIPURPOSE RESIN CEMENT
K923473 · Dentsply Intl. · Apr 1993
ARGION DENTAL CEMENT
K926492 · Voco GmbH · Apr 1993
CHAMELEON LIGHT/CHEMICAL CURE GLASS IONOMER
K930455 · Voco GmbH · Apr 1993
VITA CEREC DUO CEMENT
K925713 · Vident · Feb 1993
3M VITREMER TRI-CURE GLASS IONOMER SYSTEM
K925032 · 3M Company · Dec 1992
TYPE 1 DENTAL CEMENT
K921173 · Centrix, Inc. · Nov 1992