Cleared Traditional

K905476 - STOMADENT TM

K905476 is the FDA 510(k) clearance for STOMADENT TM by Dentsply Intl.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K905476 · Dentsply Intl. · Dental device
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Feb 1991
Decision
76d
Days
Class 2
Risk

K905476 is an FDA 510(k) clearance for the STOMADENT TM. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on February 20, 1991 after a review of 76 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dentsply Intl. devices

Submission Details

510(k) Number K905476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1990
Decision Date February 20, 1991
Days to Decision 76 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
51d faster than avg
Panel avg: 127d · This submission: 76d
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 590
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K905476.
CHARISMA
K910263 · Kulzer, Inc. · Jun 1991
VISIO-GEM ART-SYSTEM
K905604 · Espe GmbH (Us) · Mar 1991
DURAFILL COLOR VS
K905131 · Kulzer, Inc. · Mar 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