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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name handpiece, air-powered, dental
510(k) Number K113655
Device Name TI-MAX X TURBINE
Applicant
NAKANISHI, INC.
1201 richardson drive
suite 280
richardson,  TX  75080
Applicant Contact diane rutherford
Correspondent
NAKANISHI, INC.
1201 richardson drive
suite 280
richardson,  TX  75080
Correspodent Contact diane rutherford
Regulation Number872.4200
Classification Product Code
EFB  
Date Received12/12/2011
Decision Date 03/05/2012
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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