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510(k) K202278

OBS Anchorage Screw, Biokey Anchorage Screw by Bomei Co, Ltd. — Product Code OAT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2021
Date Received
August 11, 2020
Clearance Type
Special
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 Bomei Co, Ltd.

  • K152297 — OBS Anchorage Screw (February 9, 2016)

Other clearances for product code OAT

  • K242944 — Leone Orthodontic Implant TAD (Temporary Anchorage Device) (June 19, 2025)
  • K231502 — Mini Screws (September 4, 2024)
  • K231913 — T-FIT (February 8, 2024)
  • 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)
  • K201919 — Blue Sky Bio TAD (December 17, 2020)