Cleared Abbreviated

K160123 - Apinator

K160123 is an FDA 510(k) clearance for Apinator, 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 174-day FDA review.

K160123 · Allen J. Moses, Dds, Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
174d
Days
Class 2
Risk

K160123 is an FDA 510(k) clearance for the Apinator. 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 July 12, 2016 after a review of 174 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 - K160123

510(k) Number K160123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2016
Decision Date July 12, 2016
Days to Decision 174 days
Submission Type Abbreviated
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
46d slower than avg
Panel avg: 128d · This submission: 174d
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.