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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
Predetermined Change
Control Plan Authorized		 No
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