Cleared Traditional

K903481 - ALPHA-FILL, ALPHA-CEM, AND ALPHA-SILVER

K903481 is an FDA 510(k) clearance for ALPHA-FILL, manufactured by Dental Foremost. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K903481 · Dental Foremost · Dental device
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Dec 1990
Decision
137d
Days
Class 2
Risk

K903481 is an FDA 510(k) clearance for the ALPHA-FILL, ALPHA-CEM, AND ALPHA-SILVER. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Dental Foremost (Englewood, US). The FDA issued a Cleared decision on December 17, 1990 after a review of 137 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 Dental Foremost devices

FDA 510(k) Submission Details - K903481

510(k) Number K903481 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1990
Decision Date December 17, 1990
Days to Decision 137 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d slower than avg
Panel avg: 127d · This submission: 137d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBF Device Classification - Class 2, Special Controls

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 816
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K903481.
VISIO-GEM ART-SYSTEM
K905604 · Espe GmbH (Us) · Mar 1991
DURAFILL COLOR VS
K905131 · Kulzer, Inc. · 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
DURAFILL FLOW
K904555 · Kulzer, Inc. · Nov 1990