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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 K202278
Device Name OBS Anchorage Screw, Biokey Anchorage Screw
Applicant
Bomei Co, Ltd.
4F., No.1492-2, Chunrih Rd., Taoyuan Dist.
Taoyuan City,  TW 33051
Applicant Contact Steven Pan
Correspondent
Voler Biotech Consulting Co. Ltd.
No.3-1, Ln 58, Hejiang St., Zhongshan Dist.,
Taipei City,  TW 10480
Correspondent Contact Chih-Hao Kao
Regulation Number872.3640
Classification Product Code
OAT  
Date Received08/11/2020
Decision Date 01/08/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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