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Synthes Orthodontic Bone Anchor System

by Synthes (Usa) 2 variants

510(k) K093299

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK093299 Date16 Dec 2010ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
OAT
Device Class
Class II
Regulation
21 CFR Part 872.3640
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Synthes Orthodontic Bone Anchor System is an implant, endosseous, orthodontic device designed to be implanted intraorally and used as an anchor for orthodontic procedures. It comprises T-shaped plate anchors and screw anchors, with plate anchors attaching to bone via 1.55 mm cortex screws and 1.85 mm emergency screws. The system provides stable anchorage for orthodontic procedures.

The Synthes Orthodontic Bone Anchor System is supplied in various designs for attachment to the bone. It is regulated under FDA 510K and has a product code of OAT, with a regulation number of 872.3640. The device is intended for use in dental procedures and has been assigned a device class of 2 by the FDA.

Other devices from Synthes (Usa)

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Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Synthes Orthodontic Bone Anchor System used for?

    The Synthes Orthodontic Bone Anchor System is used as an anchor for orthodontic procedures, providing stable anchorage intraorally.

  • How is the Synthes Orthodontic Bone Anchor System supplied?

    The system is supplied in various designs for attachment to the bone, including T-shaped plate anchors and screw anchors.

  • Is the Synthes Orthodontic Bone Anchor System regulated by the FDA?

    Yes, the Synthes Orthodontic Bone Anchor System is regulated under FDA 510K with a product code of OAT and a regulation number of 872.3640.

  • What is the device class of the Synthes Orthodontic Bone Anchor System?

    The device has been assigned a device class of 2 by the FDA.