Cleared Traditional

K090436 - AIRWAYEASE MAS

K090436 is an FDA 510(k) clearance for AIRWAYEASE MAS, manufactured by Orthoplant Dental Lab. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 421-day FDA review.

K090436 · Orthoplant Dental Lab · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2010
Decision
421d
Days
Class 2
Risk

K090436 is an FDA 510(k) clearance for the AIRWAYEASE MAS. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Orthoplant Dental Lab (Bella Vista, New South Wales, AU). The FDA issued a Cleared decision on April 16, 2010 after a review of 421 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5570 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

FDA 510(k) Submission Details - K090436

510(k) Number K090436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 2009
Decision Date April 16, 2010
Days to Decision 421 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
293d slower than avg
Panel avg: 128d · This submission: 421d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRK Device Classification - Class 2, Special Controls

Product Code LRK Device, Anti-snoring
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5570
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 - LRK Device, Anti-snoring

All 213
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K090436.
ZQUIET MOUTHPIECE
K093407 · Sleeping Well, LLC · Jun 2010
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THE MOSES APPLIANCE
K093710 · Allen J. Moses, Dds, Ltd. · May 2010
VITAL SLEEP
K092942 · The Snore Reliever Company, LLC · Jan 2010
SILENT SLEEP
K082849 · Craniofacial Pain Center of Idaho · Jul 2009
ZQUIET MOUTHPIECE
K090503 · Sleeping Well, LLC · Mar 2009
K090436 · AIRWAYEASE MAS
Download PDF FDA Summary Orthoplant Dental Lab