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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 K904296
Device Name LYSTA HYGIENIST III SCALER
Applicant
Prodent Intl., Inc.
C/O Burditt, Bowles & Radzius
333 W. Wacker Dr., Suite 2500
Chicago,  IL  60606
Applicant Contact RICHARD O WOOD
Correspondent
Prodent Intl., Inc.
C/O Burditt, Bowles & Radzius
333 W. Wacker Dr., Suite 2500
Chicago,  IL  60606
Correspondent Contact RICHARD O WOOD
Regulation Number872.4850
Classification Product Code
ELC  
Date Received09/19/1990
Decision Date 12/05/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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