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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bone Grafting Material, Synthetic
510(k) Number K243745
Device Name FG Bone Graft B
Applicant
Full Golden Biotech Corporation
3f., # 27, Sec. 2, Henan Rd., Xitun Dist
Taichung,  TW 407
Applicant Contact Chiyu Chen
Correspondent
Voler Biotech Consulting CO., Ltd.
6f.-17, # 14, Ln. 609, Sec. 5, Chongxin Rd.,
Sanchong Dist.
New Taipei City,  TW 241407
Correspondent Contact Yvonne Chen
Regulation Number872.3930
Classification Product Code
LYC  
Date Received12/05/2024
Decision Date 08/29/2025
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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