Cleared Abbreviated

K093710 - THE MOSES APPLIANCE

K093710 is an FDA 510(k) clearance for THE MOSES APPLIANCE, manufactured by Allen J. Moses, Dds, Ltd.. The device is a Class 2 Dental device with product code LRK cleared through the Abbreviated 510(k) pathway after a 161-day FDA review.

K093710 · Allen J. Moses, Dds, Ltd. · Dental device
Download Printable Device Report (PDF)
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May 2010
Decision
161d
Days
Class 2
Risk

K093710 is an FDA 510(k) clearance for the THE MOSES APPLIANCE. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Allen J. Moses, Dds, Ltd. (Chicago, US). The FDA issued a Cleared decision on May 12, 2010 after a review of 161 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5570 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K093710

510(k) Number K093710 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2009
Decision Date May 12, 2010
Days to Decision 161 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d slower than avg
Panel avg: 128d · This submission: 161d
Pathway characteristics
Standards-based clearance path.

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 207
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