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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 K092417
Device Name INSIGHT ULTRASONIC INSERTS
Applicant
Discus Dental, LLC
8550 Higuera St.
Culver City,  CA  90232
Applicant Contact WINKIE WONG
Correspondent
Discus Dental, LLC
8550 Higuera St.
Culver City,  CA  90232
Correspondent Contact WINKIE WONG
Regulation Number872.4850
Classification Product Code
ELC  
Date Received08/07/2009
Decision Date 12/11/2009
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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