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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 K211358
Device Name Implanter incl. Accessories
Applicant
Guilin Woodpecker Medical Instrument Co., Ltd.
Information Industrial Park
Guilin National High-Tech Zone
Guilin,  CN 541004
Applicant Contact Yang Yunfeng
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713a, 17th Floor, Block A, Zhongguan Times Sq.
Liuxian Ave., Xili Town Nashan District
Shenzhen,  CN 518055
Correspondent Contact Fu Ailing
Regulation Number872.4200
Classification Product Code
EBW  
Date Received05/03/2021
Decision Date 11/21/2022
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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