Cleared Traditional

K854957 - AUSTENAL DENTAL COMPOSITE RESIN

K854957 is an FDA 510(k) clearance for AUSTENAL DENTAL COMPOSITE RESIN, manufactured by Austenal Dental, Inc.. The device is a Class 2 Dental device with product code EBD cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K854957 · Austenal Dental, Inc. · Dental device
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Jan 1986
Decision
50d
Days
Class 2
Risk

K854957 is an FDA 510(k) clearance for the AUSTENAL DENTAL COMPOSITE RESIN. Classified as Coating, Filling Material, Resin (product code EBD), Class II - Special Controls.

Submitted by Austenal Dental, Inc. (Chicago, US). The FDA issued a Cleared decision on January 30, 1986 after a review of 50 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3310 - 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 Austenal Dental, Inc. devices

FDA 510(k) Submission Details - K854957

510(k) Number K854957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1985
Decision Date January 30, 1986
Days to Decision 50 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
77d faster than avg
Panel avg: 127d · This submission: 50d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EBD Device Classification - Class 2, Special Controls

Product Code EBD Coating, Filling Material, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3310
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 - EBD Coating, Filling Material, Resin

All 41
Devices cleared under the same product code (EBD) and FDA review panel - the closest regulatory comparables to K854957.
RENAMEL FLOWABLE COMPOSITE
K974494 · Cosmedent, Inc. · Feb 1998
NO-STICK COMPOSITE INSTRUMENT DIP
K901050 · Pulpdent Corp. · Apr 1990
3M ESTHETIC DESIGN SYSTEM (TINTS & MASKING AGENTS)
K862590 · 3M Company · Jul 1986
ESPE KETAC-BOND
K844845 · Espe GmbH (Us) · Aug 1985
CURAY JOIN DENT DENTIN PRIMER
K850675 · Scientific Pharmaceuticals, Inc. · Mar 1985
CAULK DYCAL LIGHT CURED
K850641 · Dentsply Intl. · Mar 1985