BIO-RAY A-1 Anchor Screw System

Implant, Endosseous, Orthodontic

Microware Precision Co., Ltd.

The following data is part of a premarket notification filed by Microware Precision Co., Ltd. with the FDA for Bio-ray A-1 Anchor Screw System.

Pre-market Notification Details

Device IDK182929
501k NumberK182929
Device Name:BIO-RAY A-1 Anchor Screw System
ClassificationImplant, Endosseous, Orthodontic
Applicant Microware Precision Co., Ltd. No. 12, Keyuan 2nd Rd., Situn District Taichung,  TW 40763
ContactHarrison Du
CorrespondentHarrison Du
Microware Precision Co., Ltd. No. 12, Keyuan 2nd Rd., Situn District Taichung,  TW 40763
Product CodeOAT  
CFR Regulation Number872.3640 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyDental
501k Review PanelDental
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-10-22
Decision Date2019-11-06

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