Cleared Abbreviated

AIO Breathe

K233754 · Aiomega, LLC · Dental
Feb 2024
Decision
93d
Days
Class 2
Risk

About This 510(k) Submission

K233754 is an FDA 510(k) clearance for the AIO Breathe, a Device, Jaw Repositioning (Class II — Special Controls, product code LQZ), submitted by Aiomega, LLC (Tyler, US). The FDA issued a Cleared decision on February 23, 2024, 93 days after receiving the submission on November 22, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.5570.

Submission Details

510(k) Number K233754 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code LQZ — Device, Jaw Repositioning
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.5570