Orthodontic Fixation Screw [Smart Anchor Miniscrew]

FDA 510(k) K191041 · Gni Co., Ltd.

Substantially Equivalent

510(k) numberK191041

Submission

Device name
Orthodontic Fixation Screw [Smart Anchor Miniscrew]
Applicant
Gni Co., Ltd.
Hwaseong, KR
Received
April 19, 2019
Decision date
August 28, 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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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
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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

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Questions and answers

When was Orthodontic Fixation Screw [Smart Anchor Miniscrew] cleared by the FDA?

Orthodontic Fixation Screw [Smart Anchor Miniscrew] (K191041) received a 510(k) decision of Substantially Equivalent on August 28, 2020, 497 days after the submission was received.

What is the product code of K191041?

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