Not Cleared Direct

DEN200018 - eXciteOSA with remote and eXciteOSA without remote (FDA 510(k) Clearance)

Class II Dental device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN200018 · Signifier Medical Technologies · Dental device
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Feb 2021
Decision
318d
Days
Class 2
Risk

DEN200018 is an FDA 510(k) submission (not cleared) for the eXciteOSA with remote and eXciteOSA without remote. Classified as Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea (product code QNO), Class II - Special Controls.

Submitted by Signifier Medical Technologies (London, GB). The FDA issued a Not Cleared (DENG) decision on February 5, 2021 after a review of 318 days.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5575 - the FDA dental device regulatory framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 318 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

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Submission Details

510(k) Number DEN200018 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 24, 2020
Decision Date February 05, 2021
Days to Decision 318 days
Submission Type Direct
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
191d slower than avg
Panel avg: 127d · This submission: 318d
Pathway characteristics

Device Classification

Product Code QNO Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5575
Definition A Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring And Obstructive Sleep Apnea Consists Of A Removable Intraoral Mouthpiece That Uses Electrodes To Deliver Neuromuscular Stimulation To The Tongue To Strengthen Tongue Musculature To Reduce Snoring And Obstructive Sleep Apnea.
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.