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FDA 510(k)

Bio-TackS Orthodontic Mini Implant

K-Number: K190871 · 2020-01-17

ApplicantBiocetec Co., Ltd.
Decision Date2020-01-17
Product CodeOAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Bio-TackS Orthodontic Mini Implant is the device name listed in this FDA 510(k) record. The listed applicant is Biocetec Co., Ltd.. It received FDA 510(k) clearance on 2020-01-17 under 510(k) 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. The listed applicant is Biocetec Co., Ltd.. The 510(k) number is K190871.

When did Bio-TackS Orthodontic Mini Implant receive FDA 510(k) clearance?

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

Who is the listed applicant for Bio-TackS Orthodontic Mini Implant?

The FDA 510(k) record lists Biocetec Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Biocetec Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: OAT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260268OrthoEasy Pal; OrthoEasy Pal Long NeckBernhard Förster GmbH (Bernhard Foerster Ltd.)K242944Leone Orthodontic Implant TAD (Temporary Anchorage Device)Leone S.P.A.K231502Mini ScrewsProimtech Saglik Urunleri Anonim SirketiK231913T-FITTechwin Co., Ltd.K222245ACR Screw SystemBiomaterials Korea, Inc.K202163Mico One Orthodontic ScrewZe Fang Technology Co., Ltd.

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.

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