OBS Anchorage Screw, Biokey Anchorage Screw

Implant, Endosseous, Orthodontic

Bomei Co, Ltd.

The following data is part of a premarket notification filed by Bomei Co, Ltd. with the FDA for Obs Anchorage Screw, Biokey Anchorage Screw.

Pre-market Notification Details

Device IDK202278
510k NumberK202278
Device Name:OBS Anchorage Screw, Biokey Anchorage Screw
ClassificationImplant, Endosseous, Orthodontic
Applicant Bomei Co, Ltd. 4F., No.1492-2, Chunrih Rd., Taoyuan Dist. Taoyuan City,  TW 33051
ContactSteven Pan
CorrespondentChih-hao Kao
Voler Biotech Consulting Co. Ltd. No.3-1, Ln 58, Hejiang St., Zhongshan Dist., Taipei City,  TW 10480
Product CodeOAT  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-11
Decision Date2021-01-08

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