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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Scaler, Ultrasonic
510(k) Number K102218
Device Name COMPACT PIEZO P2K, POWERCARE
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 Number872.4850
Classification Product Code
ELC  
Date Received08/06/2010
Decision Date 01/24/2011
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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