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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 K213947
Device Name Ultrasonic Endo Activation Device (Model:Actor I pro)
Applicant
Changzhou Bomedent Medical Technology Co.,Ltd
#9 Changyang Rd.,West Taihu Science & Technology
Industrial Park,
Changzhou,  CN 213100
Applicant Contact Yang Chunyuan
Correspondent
Changzhou Bomedent Medical Technology Co.,Ltd
#9 Changyang Rd.,West Taihu Science & Technology
Industrial Park,
Changzhou,  CN 213100
Correspondent Contact Yang Chunyuan
Regulation Number872.4850
Classification Product Code
ELC  
Date Received12/17/2021
Decision Date 09/08/2022
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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