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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 K043408
Device Name PIEZOSURGERY DEVICE
Applicant
Piezosurgery S.R.L.
Piazza Albania 10
Rome,  IT 00153
Applicant Contact Maria E Donawa
Correspondent
Piezosurgery S.R.L.
Piazza Albania 10
Rome,  IT 00153
Correspondent Contact Maria E Donawa
Regulation Number872.4120
Classification Product Code
DZI  
Date Received12/10/2004
Decision Date 06/08/2005
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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