Cleared Traditional

K852981 - PREFORMED TOOTH ARCH

K852981 is an FDA 510(k) clearance for PREFORMED TOOTH ARCH, manufactured by Swipes Dental Laboratory. The device is a Class 2 Dental device with product code ELM cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K852981 · Swipes Dental Laboratory · Dental device
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Aug 1985
Decision
32d
Days
Class 2
Risk

K852981 is an FDA 510(k) clearance for the PREFORMED TOOTH ARCH. Classified as Denture, Plastic, Teeth (product code ELM), Class II - Special Controls.

Submitted by Swipes Dental Laboratory (Harrisburg, US). The FDA issued a Cleared decision on August 16, 1985 after a review of 32 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.

View all Swipes Dental Laboratory devices

FDA 510(k) Submission Details - K852981

510(k) Number K852981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1985
Decision Date August 16, 1985
Days to Decision 32 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 128d · This submission: 32d
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 36
Devices cleared under the same product code (ELM) and FDA review panel - the closest regulatory comparables to K852981.
VITAPAN ACRYLIC DENTURE TEETH
K914476 · Vident · Mar 1992
DENTURE PLASTIC TEETH,76 ELM
K915276 · Nobelpharma USA, Inc. · Feb 1992
AUSTENAL MODIFIED ACRYLIC DENTURE RESIN
K853160 · Austenal Dental, Inc. · Oct 1985
DELTA TEETH
K831214 · Dentsply Intl. · May 1983
TEETH, DENTURE, PLASTIC
K792245 · Dentsply Intl. · Jan 1980
ANTERIORS AND POSTERIORS, PLASTIC
K780217 · Dentsply Intl. · Mar 1978