Cleared Abbreviated

K233754 - AIO Breathe

K233754 is an FDA 510(k) clearance for AIO Breathe, manufactured by Aiomega, LLC. The device is a Class 2 Dental device with product code LQZ cleared through the Abbreviated 510(k) pathway after a 93-day FDA review.

K233754 · Aiomega, LLC · Dental device
Download Printable Device Report (PDF)
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Feb 2024
Decision
93d
Days
Class 2
Risk

K233754 is an FDA 510(k) clearance for the AIO Breathe. Classified as Device, Jaw Repositioning (product code LQZ), Class II - Special Controls.

Submitted by Aiomega, LLC (Tyler, US). The FDA issued a Cleared decision on February 23, 2024 after a review of 93 days - within the typical 510(k) review window.

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.

View all Aiomega, LLC devices

FDA 510(k) Submission Details - K233754

510(k) Number K233754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2023
Decision Date February 23, 2024
Days to Decision 93 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
35d faster than avg
Panel avg: 128d · This submission: 93d
Pathway characteristics
Standards-based clearance path.

LQZ Device Classification - Class 2, Special Controls

Product Code LQZ Device, Jaw Repositioning
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 - LQZ Device, Jaw Repositioning

All 17
Devices cleared under the same product code (LQZ) and FDA review panel - the closest regulatory comparables to K233754.
RADx Intraoral Appliance for Snoring and Sleep Apnea
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The Slide
K203712 · Biotex, Inc. · Jul 2021
Slow Wave DS8
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The NightBlocks Appliance
K192581 · Advanced Facialdontics, LLC · Jan 2020
SML-OSA2 Appliances
K162816 · Selane Products, Inc. · Jul 2017
ATG/SM-OSA APPLIANCES
K130130 · Selane Products, Inc. · Aug 2013