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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
Model VARIOS 970/VARIOS 970LUX
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 (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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