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510(k) K210559

ATOZ Mini-Screw by Mk Meditech, Inc. — Product Code OAT

K210559 is an FDA 510(k) premarket notification submitted by Mk Meditech, Inc. for the device "ATOZ Mini-Screw". The FDA issued a decision of Substantially Equivalent on December 19, 2021. 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
December 19, 2021
Date Received
February 25, 2021
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)
  • K202163 — Mico One Orthodontic Screw (October 7, 2022)
  • K202691 — Ortholock Anchorage Devices (April 28, 2022)
  • 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