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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 K083569
Device Name SURGYBONE
Applicant
Silfradent S.R.L.
110 E. Granada Blvd., Suite 207
Ormond Beach,  FL  32176
Applicant Contact CLAUDE D BERTHOIN
Correspondent
Silfradent S.R.L.
110 E. Granada Blvd., Suite 207
Ormond Beach,  FL  32176
Correspondent Contact CLAUDE D BERTHOIN
Regulation Number872.4120
Classification Product Code
DZI  
Date Received12/03/2008
Decision Date 04/01/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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