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510(k) K063495

C TYPE, CT TYPE, AND SPECIAL TYPE ORTHODONTIC ANCHOR SCREWS by Biomaterials Korea, Inc. — Product Code OAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2007
Date Received
November 20, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Orthodontic
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type

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 clearances by Biomaterials Korea, Inc.

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  • K110926 — BONE PLATE; BONE SCREW (December 8, 2011)
  • K111809 — SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS (September 26, 2011)

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  • K222245 — ACR Screw System (August 21, 2023)
  • K202163 — Mico One Orthodontic Screw (October 7, 2022)
  • K202691 — Ortholock Anchorage Devices (April 28, 2022)
  • K210559 — ATOZ Mini-Screw (December 19, 2021)
  • K211992 — Ortho MI System (October 15, 2021)
  • K202790 — Syntec Orthodontic Mini Screw Extended System (September 17, 2021)
  • K202278 — OBS Anchorage Screw, Biokey Anchorage Screw (January 8, 2021)