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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 K171553
Device Name W&H Assistina Twin
Applicant
W&H Dentalwerk Buermoos GmbH
Ignaz-Glaser-Strabe 53
Buermoos,  AT 5111
Applicant Contact Mag. Anja Lindner
Correspondent
W&H Dentalwerk Buermoos GmbH
Ignaz-Glaser-Strabe 53
Buermoos,  AT 5111
Correspondent Contact Mag. Anja Lindner
Regulation Number872.4200
Classification Product Code
EFB  
Date Received05/30/2017
Decision Date 12/08/2017
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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