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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 K060274
Device Name PIEZOTOME
Applicant
Satelec
130 Gaither Dr.
Suite 100
Mt. Laurel,  NJ  08054
Applicant Contact STEVE SALESKY
Correspondent
Satelec
130 Gaither Dr.
Suite 100
Mt. Laurel,  NJ  08054
Correspondent Contact STEVE SALESKY
Regulation Number872.4120
Classification Product Code
DZI  
Date Received02/02/2006
Decision Date 05/01/2006
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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