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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 K053578
Device Name SCORPION ULTRASONIC SCALING INSERTS
Applicant
Scorpion
333 Milford Rd.
Deerfield,  IL  60015
Applicant Contact DANIEL KAMM
Correspondent
Scorpion
333 Milford Rd.
Deerfield,  IL  60015
Correspondent Contact DANIEL KAMM
Regulation Number872.4850
Classification Product Code
ELC  
Date Received12/22/2005
Decision Date 07/14/2006
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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