Cleared Traditional

K853160 - AUSTENAL MODIFIED ACRYLIC DENTURE RESIN

K853160 is an FDA 510(k) clearance for AUSTENAL MODIFIED ACRYLIC DENTURE RESIN, manufactured by Austenal Dental, Inc.. The device is a Class 2 Dental device with product code ELM cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K853160 · Austenal Dental, Inc. · Dental device
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Oct 1985
Decision
93d
Days
Class 2
Risk

K853160 is an FDA 510(k) clearance for the AUSTENAL MODIFIED ACRYLIC DENTURE RESIN. Classified as Denture, Plastic, Teeth (product code ELM), Class II - Special Controls.

Submitted by Austenal Dental, Inc. (Chicago, US). The FDA issued a Cleared decision on October 31, 1985 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3590 - 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 Austenal Dental, Inc. devices

FDA 510(k) Submission Details - K853160

510(k) Number K853160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 1985
Decision Date October 31, 1985
Days to Decision 93 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
34d faster than avg
Panel avg: 127d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELM Device Classification - Class 2, Special Controls

Product Code ELM Denture, Plastic, Teeth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3590
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 - ELM Denture, Plastic, Teeth

All 19
Devices cleared under the same product code (ELM) and FDA review panel - the closest regulatory comparables to K853160.
NEW TOOTH MATERIAL
K920684 · Dentsply Intl. · Dec 1992
VITAPAN ACRYLIC DENTURE TEETH
K914476 · Vident · Mar 1992
DENTURE PLASTIC TEETH,76 ELM
K915276 · Nobelpharma USA, Inc. · Feb 1992
DELTA TEETH
K831214 · Dentsply Intl. · May 1983
TEETH, DENTURE, PLASTIC
K792245 · Dentsply Intl. · Jan 1980
ANTERIORS AND POSTERIORS, PLASTIC
K780217 · Dentsply Intl. · Mar 1978