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510(k) K202163

Mico One Orthodontic Screw by Ze Fang Technology Co., Ltd. — Product Code OAT

K202163 is an FDA 510(k) premarket notification submitted by Ze Fang Technology Co., Ltd. for the device "Mico One Orthodontic Screw". The FDA issued a decision of Substantially Equivalent on October 7, 2022. The device falls under product code OAT (Implant, Endosseous, Orthodontic), a Class II device regulated under 21 CFR 872.3640.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 7, 2022
Date Received
August 3, 2020
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 for product code OAT

  • K260268 — OrthoEasy Pal; OrthoEasy Pal Long Neck (May 19, 2026)
  • 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)
  • 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)

FDA data resources