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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drill, Bone, Powered
510(k) Number K133488
Device Name PIEZOMED
Applicant
W&H Dentalwerk Buermoos GmbH
Ignaz-Glaser-Strasse 53
Burmoos,  AT 5111
Applicant Contact ANJA LINDNER
Correspondent
W&H Dentalwerk Buermoos GmbH
Ignaz-Glaser-Strasse 53
Burmoos,  AT 5111
Correspondent Contact ANJA LINDNER
Regulation Number872.4120
Classification Product Code
DZI  
Subsequent Product Code
ELC  
Date Received11/13/2013
Decision Date 10/16/2014
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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