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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 K122322
Device Name PIEZOSURGERY TOUCH
Applicant
Mectron S.P.A.
Piazza Albania 10
Rome,  IT 00153
Applicant Contact ROGER GRAY
Correspondent
Mectron S.P.A.
Piazza Albania 10
Rome,  IT 00153
Correspondent Contact ROGER GRAY
Regulation Number872.4120
Classification Product Code
DZI  
Subsequent Product Code
ELC  
Date Received08/01/2012
Decision Date 12/06/2012
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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