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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 K182145
Device Name tün® ultrasonic tips product family
Applicant
Engineered Endodontics
W134 N4965 Campbell Dr.
Menomonee Falls,  WI  53051
Applicant Contact Mark Fiorina
Correspondent
Spectramedex, LLC
3215 Golf Rd. #1459
Delafield,  WI  53018
Correspondent Contact John Ziobro
Regulation Number872.4850
Classification Product Code
ELC  
Date Received08/08/2018
Decision Date 06/07/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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