Bio-TackS Orthodontic Mini Implant

FDA 510(k) K190871 · Biocetec Co., Ltd.

Substantially Equivalent

510(k) numberK190871

Submission

Device name
Bio-TackS Orthodontic Mini Implant
Applicant
Biocetec Co., Ltd.
Seoul, KR
Received
April 3, 2019
Decision date
January 17, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OAT – Implant, Endosseous, Orthodontic
Device class
Class II (moderate risk)
Regulation
21 CFR 872.3640
Specialty
Dental
Implant
Yes

It is intended to provide a fixed anchorage point for attachment of orthodontic appliances to facilitate the orthodontic movement of teeth. It is used temporarily and is removed after orthodontic treatment has been completed.

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K260268OrthoEasy Pal; OrthoEasy Pal Long NeckOAT · Traditional Bernhard Förster GmbH (Bernhard Foerster Ltd.)05/19/2026SE
K242944Leone Orthodontic Implant TAD (Temporary Anchorage Device)OAT · Traditional Leone S.P.A.06/19/2025SE
K231502Mini ScrewsOAT · Traditional Proimtech Saglik Urunleri Anonim Sirketi09/04/2024SE
K231913T-FitOAT · Traditional Techwin Co., Ltd.02/08/2024SE
K222245ACR Screw SystemOAT · Traditional Biomaterials Korea, Inc.08/21/2023SE
K202163Mico One Orthodontic ScrewOAT · Traditional Ze Fang Technology Co., Ltd.10/07/2022SE
K202691Ortholock Anchorage DevicesOAT · Traditional Craniofacial Technologies, Inc.04/28/2022SE
K210559ATOZ Mini-ScrewOAT · Traditional Mk Meditech, Inc.12/19/2021SE
K211992Ortho MI SystemOAT · Traditional Osteonic Co., Ltd.10/15/2021SE
K202790Syntec Orthodontic Mini Screw Extended SystemOAT · Special Syntec Scientific Corporation09/17/2021SE

More from Syntec Scientific Corporation

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K231635A-Line AdvancedNJM · Traditional 06/06/2023SE
K182193S-LineNJM · Traditional 01/22/2019SE
K163467C-Line Orthodontic Ceramic BracketNJM · Traditional 06/14/2017SE

Questions and answers

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

Bio-TackS Orthodontic Mini Implant (K190871) received a 510(k) decision of Substantially Equivalent on January 17, 2020, 289 days after the submission was received.

What is the product code of K190871?

The FDA product code is OAT – Implant, Endosseous, Orthodontic, a Class II (moderate risk) device regulated under 21 CFR 872.3640.