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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Handpiece, Air-Powered, Dental
510(k) Number K242179
Device Name Synea Fusion Handpieces (Intensiv & Profin)
Applicant
W&H Dentalwerk Bürmoos GmbH
Ignaz-Glaser-Straße 53
Buermoos,  AT 5111
Applicant Contact Gerhard Weidler
Correspondent
W&H Dentalwerk Bürmoos GmbH
Ignaz-Glaser-Straße 53
Buermoos,  AT 5111
Correspondent Contact Gerhard Weidler
Regulation Number872.4200
Classification Product Code
EFB  
Date Received07/25/2024
Decision Date 02/28/2025
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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