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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 K253655
Device Name Angled Screwdriver MED (M-SD090)
Applicant
W&H Dentalwerk Bürmoos GmbH
Werner-Bader-Straße 1
Buermoos,  AT 5111
Applicant Contact Gerhard Weidler
Correspondent
W&H Dentalwerk Bürmoos GmbH
Werner-Bader-Straße 1
Buermoos,  AT 5111
Correspondent Contact Gerhard Weidler
Regulation Number872.4120
Classification Product Code
DZI  
Subsequent Product Code
DZJ  
Date Received11/20/2025
Decision Date 07/31/2026
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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