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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name implant, endosseous, orthodontic
510(k) Number K202163
Device Name Mico One Orthodontic Screw
Applicant
Ze Fang Technology Co., Ltd.
No.17, Aly. 81, Ln. 2, Sec. 1, Zhongxing Rd., Dali Dist.,
Taichung City, Taiwan
Taichung,  TW 412
Applicant Contact Anita Chen
Correspondent
ZhengCheng Consulting Limited Company
No.19, 335 Lane, Fu-Xi Road, Shulin District
New Taipei City,  TW 238
Correspondent Contact Anita Chen
Regulation Number872.3640
Classification Product Code
OAT  
Date Received08/03/2020
Decision Date 10/07/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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