Cleared Abbreviated

RADx Intraoral Appliance for Snoring and Sleep Apnea

K230532 · Achaemenid, LLC · Dental

Jul 2023

Decision

135d

Days

Class 2

Risk

About This 510(k) Submission

K230532 is an FDA 510(k) clearance for the RADx Intraoral Appliance for Snoring and Sleep Apnea, a Device, Jaw Repositioning (Class II — Special Controls, product code LQZ), submitted by Achaemenid, LLC (Stratford, US). The FDA issued a Cleared decision on July 12, 2023, 135 days after receiving the submission on February 27, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.5570.

Submission Details

510(k) Number	K230532 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 27, 2023
Decision Date	July 12, 2023
Days to Decision	135 days
Submission Type	Abbreviated
Review Panel	Dental (DE)
Summary	Summary PDF