C Type, CT Type, and Special Type Orthodontic Anchor Screws

FDA 510(k) K063495 · Biomaterials Korea, Inc.

Substantially Equivalent

510(k) numberK063495

Submission

Device name
C Type, CT Type, and Special Type Orthodontic Anchor Screws
Applicant
Biomaterials Korea, Inc.
Littleton, CO, US
Received
November 20, 2006
Decision date
July 26, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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.

Other 510(k)s with product code OAT

510(k)DeviceApplicantDecision
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

510(k)DeviceDecision
K222245ACR Screw SystemOAT · Traditional 08/21/2023SE
K173623Anchor plateOAT · Traditional 08/30/2018SE
K110926Bone Plate; Bone ScrewJEY · Traditional 12/08/2011SE
K111809SL Type Orthodontic Anchor Screws, SPL Type Orthodontic Anchor ScrewsOAT · Special 09/26/2011SE

Questions and answers

When was C Type, CT Type, and Special Type Orthodontic Anchor Screws cleared by the FDA?

C Type, CT Type, and Special Type Orthodontic Anchor Screws (K063495) received a 510(k) decision of Substantially Equivalent on July 26, 2007, 248 days after the submission was received.

What is the product code of K063495?

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