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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 K202371
Device Name Highspeed Airturbine Handpiece
Applicant
Beijing Dongbo Dental Handpiece Co., Ltd.
3f, Bldg. 3, # 17, First Jinmayuan St.,
Shunyi District
Beijing,  CN 101318
Applicant Contact Chao Hao
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Regulation Number872.4200
Classification Product Code
EFB  
Date Received08/19/2020
Decision Date 11/08/2021
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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