Cleared Traditional

K905131 - DURAFILL COLOR VS

K905131 is the FDA 510(k) clearance for DURAFILL COLOR VS by Kulzer, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K905131 · Kulzer, Inc. · Dental device
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Mar 1991
Decision
120d
Days
Class 2
Risk

K905131 is an FDA 510(k) clearance for the DURAFILL COLOR VS. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Kulzer, Inc. (Irvine, US). The FDA issued a Cleared decision on March 15, 1991 after a review of 120 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 Kulzer, Inc. devices

Submission Details

510(k) Number K905131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1990
Decision Date March 15, 1991
Days to Decision 120 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d faster than avg
Panel avg: 127d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 598
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K905131.
DEGULUX LIGHT CURING UNIT
K912037 · Degussa AG · Jun 1991
CHARISMA
K910263 · Kulzer, Inc. · Jun 1991
VISIO-GEM ART-SYSTEM
K905604 · Espe GmbH (Us) · Mar 1991
STOMADENT TM
K905476 · Dentsply Intl. · Feb 1991
MONOBOND S
K905220 · Ivoclar North America, Inc. · Dec 1990
SPECIAL BOND II
K905221 · Ivoclar North America, Inc. · Dec 1990