Cleared Traditional

K173856 - Express 4 Sleep appliance/CPAP Sidekick...

K173856 is an FDA 510(k) clearance for Express 4 Sleep appliance/CPAP Sidekick..., manufactured by Moses Appliances, LLC. The device is a Class 2 Dental device with product code LRK cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K173856 · Moses Appliances, LLC · Dental device
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Jun 2018
Decision
188d
Days
Class 2
Risk

K173856 is an FDA 510(k) clearance for the Express 4 Sleep appliance/CPAP Sidekick appliance. Classified as Device, Anti-snoring (product code LRK), Class II - Special Controls.

Submitted by Moses Appliances, LLC (Indian Wells, US). The FDA issued a Cleared decision on June 26, 2018 after a review of 188 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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Moses Appliances, LLC devices

FDA 510(k) Submission Details - K173856

510(k) Number K173856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2017
Decision Date June 26, 2018
Days to Decision 188 days
Submission Type Traditional
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
61d slower than avg
Panel avg: 127d · This submission: 188d
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 85
Devices cleared under the same product code (LRK) and FDA review panel - the closest regulatory comparables to K173856.
Oral Device OA, Oral Device S
K181396 · Passion For Life Healthcare (Uk) Limited · Nov 2018
myTAP2
K181482 · Airway Management, Inc. · Aug 2018
Advanced Dental Applicance
K172991 · Dasoft Partners · Jul 2018
ZQuiet
K180124 · Sleeping Well, LLC · Jun 2018
REST EAZY Appliance
K172760 · Insert Molding Solutions, Inc. · Mar 2018
The Panthera Anti-Snoring X3 Device
K171576 · Panthera Dental, Inc. · Feb 2018