Cleared Traditional

K924526 - DENTURE PLASTIC TEETH

K924526 is an FDA 510(k) clearance for DENTURE PLASTIC TEETH, manufactured by Austenal, Inc.. The device is a Class 2 Dental device with product code ELM cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K924526 · Austenal, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 1992
Decision
57d
Days
Class 2
Risk

K924526 is an FDA 510(k) clearance for the DENTURE PLASTIC TEETH. Classified as Denture, Plastic, Teeth (product code ELM), Class II - Special Controls.

Submitted by Austenal, Inc. (Chicago, US). The FDA issued a Cleared decision on November 4, 1992 after a review of 57 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K924526

510(k) Number K924526 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1992
Decision Date November 04, 1992
Days to Decision 57 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 128d · This submission: 57d
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 47
Devices cleared under the same product code (ELM) and FDA review panel - the closest regulatory comparables to K924526.
COMPATIT R
K913582 · Wilde-USA, Inc. · Jun 1993
KING-HUE, ROYAL CORAL, SUPER-C ARTIFICIAL TEETH
K931162 · King Dental Corp. · May 1993
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
TRUETECH MEDICAL, INC. DENTURE CUPS
K871160 · Zenex Medical, Inc. · Jun 1987
K924526 · DENTURE PLASTIC TEETH
Download PDF FDA Summary Austenal, Inc.