Cleared Traditional

K904813 - VISIBLE LIGHT CURE COMPOSITE DENTAL RESTOR. MAT.

K904813 is an FDA 510(k) clearance for VISIBLE LIGHT CURE COMPOSITE DENTAL RES..., manufactured by Alpha-Dent. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K904813 · Alpha-Dent · Dental device
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May 1991
Decision
218d
Days
Class 2
Risk

K904813 is an FDA 510(k) clearance for the VISIBLE LIGHT CURE COMPOSITE DENTAL RESTOR. MAT.. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Alpha-Dent (Chicago, US). The FDA issued a Cleared decision on May 31, 1991 after a review of 218 days - an extended review cycle.

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 Alpha-Dent devices

FDA 510(k) Submission Details - K904813

510(k) Number K904813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1990
Decision Date May 31, 1991
Days to Decision 218 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 127d · This submission: 218d
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 813
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K904813.
CLEARFIL PHOTO ANTERIOR & LINER BOND SYSTEM
K912708 · Kuraray Co. · Aug 1991
DEGULUX LIGHT CURING UNIT
K912037 · Degussa AG · Jun 1991
CHARISMA
K910263 · Kulzer, Inc. · Jun 1991
PALFIQUE ESTELITE
K911524 · Tokuyama America, Inc. · May 1991
VISIO-GEM ART-SYSTEM
K905604 · Espe GmbH (Us) · Mar 1991
DURAFILL COLOR VS
K905131 · Kulzer, Inc. · Mar 1991