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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 K091227
Device Name PIEZOSURGERY 3; OSSTEM PIEZO
Applicant
Piezosurgery S.R.L.
Via Aldo Moro 20
Brescia,  IT 25124
Applicant Contact ING. ENRICO PERFLER
Correspondent
Piezosurgery S.R.L.
Via Aldo Moro 20
Brescia,  IT 25124
Correspondent Contact ING. ENRICO PERFLER
Regulation Number872.4120
Classification Product Code
DZI  
Date Received04/28/2009
Decision Date 12/29/2009
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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