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
Download Printable Device Report (PDF)
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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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d slower than avg
Panel avg: 128d · 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.

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All 207
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