Cleared Special

K132933 - THE MOSES ELITE APPLIANCE

K132933 is an FDA 510(k) clearance for THE MOSES ELITE APPLIANCE, manufactured by Allen J. Moses, Dds, Ltd.. The device is a Class 2 Dental device with product code LRK cleared through the Special 510(k) pathway after a 219-day FDA review.

K132933 · Allen J. Moses, Dds, Ltd. · Dental device
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Apr 2014
Decision
219d
Days
Class 2
Risk

K132933 is an FDA 510(k) clearance for the THE MOSES ELITE 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 April 25, 2014 after a review of 219 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Allen J. Moses, Dds, Ltd. devices

FDA 510(k) Submission Details - K132933

510(k) Number K132933 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2013
Decision Date April 25, 2014
Days to Decision 219 days
Submission Type Special
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d slower than avg
Panel avg: 127d · This submission: 219d
Pathway characteristics
Modification to existing cleared device.

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 86
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