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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
510(k) Number K213221
Device Name AMADEO, M-UK1015 (incl. attachments and accessories)
Applicant
W&H Dentalwerk Buermoss GmbH
Ignaz-Glaser-Strasse 53
Buermoos,  AT 5111
Applicant Contact Weidler Gerhard
Correspondent
W&H Dentalwerk Buermoss GmbH
Ignaz-Glaser-Strasse 53
Buermoos,  AT 5111
Correspondent Contact Weidler Gerhard
Regulation Number874.4250
Classification Product Code
ERL  
Subsequent Product Code
DZI  
Date Received09/29/2021
Decision Date 05/26/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
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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