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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 K193264
Device Name Disposable High Speed Air Turbine Handpiece
Applicant
Ningbo Hpdove Dental Instruments Co., Ltd.
#588 Xiaolin Rd., Xiaolin Town
Cixi City,  CN 315321
Applicant Contact Liyue Huang
Correspondent
Irc
2950 E Lindrick Dr.
Chandler,  AZ  85249
Correspondent Contact Charlie Mack
Regulation Number872.4200
Classification Product Code
EFB  
Date Received11/26/2019
Decision Date 08/11/2020
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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