Cleared Traditional

Express 4 Sleep appliance/CPAP Sidekick appliance (K173856) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K173856 · Moses Appliances, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 80
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