FDA 510(k)

Bio-TackS Orthodontic Mini Implant

K-Number: K190871 · 2020-01-17

Decision Date2020-01-17

Product CodeOAT

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Bio-TackS Orthodontic Mini Implant is a medical device manufactured by Biocetec Co., Ltd.. It received FDA 510(k) clearance on 2020-01-17 under approval number K190871. The device is classified under product code OAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bio-TackS Orthodontic Mini Implant?

Bio-TackS Orthodontic Mini Implant is a medical device that received FDA 510(k) clearance on 2020-01-17. It is manufactured by Biocetec Co., Ltd.. The 510(k) number is K190871.

When was Bio-TackS Orthodontic Mini Implant approved by the FDA?

Bio-TackS Orthodontic Mini Implant received FDA 510(k) clearance on 2020-01-17, under approval number K190871.

What company makes Bio-TackS Orthodontic Mini Implant?

Bio-TackS Orthodontic Mini Implant is manufactured by Biocetec Co., Ltd..

What is the FDA product code for Bio-TackS Orthodontic Mini Implant?

The FDA product code for Bio-TackS Orthodontic Mini Implant is OAT.

Related Clinical Trials

NCT05639907 Miniscrew Stability and Peri-implant Inflammation When Precoated K21 vs Ethanol Control RECRUITING

Other Devices by Biocetec Co., Ltd.

K163467C-Line Orthodontic Ceramic Bracket K182193S-Line K231635A-Line Advanced

Related Devices (Code: OAT)

K161197Orthodontic ScrewOsstem Implant Co., Ltd. K152297OBS Anchorage ScrewBomei Co, Ltd. K161335Dual Top Screw SystemJeil Medical Corporation K173623Anchor plateBiomaterials Korea, Inc. K182929BIO-RAY A-1 Anchor Screw SystemMicroware Precision Co., Ltd. K181142Absoanchor MicroimplantDentos, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.