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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthodontic Led Accessory
510(k) Number K230905
Device Name OrthoPulse 2.0E (OPi2E-100)
Applicant
Biolux Technology GmbH
Neubaugasse 31
Absdorf,  AT 3462
Applicant Contact Daniela Penn
Correspondent
Biolux Technology GmbH
Neubaugasse 31
Absdorf,  AT 3462
Correspondent Contact Daniela Penn
Regulation Number872.5470
Classification Product Code
PLH  
Date Received03/31/2023
Decision Date 06/09/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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