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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Jaw Repositioning
510(k) Number K230532
Device Name RADx Intraoral Appliance for Snoring and Sleep Apnea
Applicant
Achaemenid, LLC
2318 Main St.
Stratford,  CT  06615
Applicant Contact Rachel Miller
Correspondent
Aztech Regulatory & Quality, LLC
543 Long Hill Ave.
Shelton,  CT  06484
Correspondent Contact Joseph Azary
Regulation Number872.5570
Classification Product Code
LQZ  
Subsequent Product Code
LRK  
Date Received02/27/2023
Decision Date 07/12/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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