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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 K113430
Device Name PROULTRA PIEZO ULTRASONIC
Applicant
Satelec - Acteon Group
124 Gaither Dr. Suite #140
Mt. Laurel,  NJ  08054
Applicant Contact RICK ROSATI
Correspondent
Satelec - Acteon Group
124 Gaither Dr. Suite #140
Mt. Laurel,  NJ  08054
Correspondent Contact RICK ROSATI
Regulation Number872.4850
Classification Product Code
ELC  
Date Received11/21/2011
Decision Date 02/23/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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