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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Injector, Jet, Mechanical-Powered
510(k) Number K243427
Device Name QuickSleeper 5
Applicant
Dentalhitec
Zi Appentiere
Rue De Champ Blanc
Mazieres En Mauges,  FR 49280
Applicant Contact Olivier Villette
Correspondent
Qrs Solutions, LLC
966 E. 2050 N
Ogden,  UT  84414
Correspondent Contact Adrienne von Foller
Regulation Number872.4475
Classification Product Code
EGM  
Subsequent Product Code
EJI  
Date Received11/05/2024
Decision Date 08/01/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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