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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Controller, Foot, Handpiece And Cord
510(k) Number K203706
Device Name Dental Electric Motor
Applicant
Guilin Woodpecker Medical Instrument Co., Ltd.
Information Industrial Park
Guilin National High-Tech Zone
Guilin,  CN 541004
Applicant Contact Jiakang Ning
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
Block A, Zhongguan Times Sq., Liuxian Ave.,
Xili Town, Nanshan District
Shenzhen,  CN
Correspondent Contact Field Fu
Regulation Number872.4200
Classification Product Code
EBW  
Subsequent Product Code
EGS  
Date Received12/18/2020
Decision Date 01/13/2022
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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