Alpha-Bio Orthodontic Fixation Screw System

FDA 510(k) K063770 · Alpha-Bio Tec , Ltd.

Substantially Equivalent

510(k) numberK063770

Submission

Device name
Alpha-Bio Orthodontic Fixation Screw System
Applicant
Alpha-Bio Tec , Ltd.
Washington, DC, US
Received
December 20, 2006
Decision date
March 26, 2007
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
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

510(k)DeviceDecision
K063769Alpha Bio Bone Fixation Screw SystemDZL · Traditional 03/30/2007SE
K063364Alpha Bio Dental Implant SystemDZE · Traditional 03/14/2007SE

Questions and answers

When was Alpha-Bio Orthodontic Fixation Screw System cleared by the FDA?

Alpha-Bio Orthodontic Fixation Screw System (K063770) received a 510(k) decision of Substantially Equivalent on March 26, 2007, 96 days after the submission was received.

What is the product code of K063770?

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