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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 K113530
Device Name ULTRASONIC SCALER
Original Applicant
NAKANISHI, INC.
1201 richardson drive
suite 280
richardson,  TX  75080
Original Contact diane rutherford
Regulation Number872.4850
Classification Product Code
ELC  
Date Received11/30/2011
Decision Date 01/31/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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