Skip to content

Ortrautek Orthognathic System

by Tekka

510(k) K031989

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK031989 Date28 Oct 2003ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
JEY
Device Class
Class II
Regulation
21 CFR Part 872.4760
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

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

The ORTRAUTEK ORTHOGNATHIC SYSTEM is a dental device classified as a plate, bone, intended for use in orthognathic procedures. It is categorized under medical specialty description Dental and is regulated under regulation number 872.4760.

The device is intended for use by dental professionals and is subject to FDA 510(k) clearance. It is not specified whether the device is single-use or reusable, and no information regarding sterility, storage, or MRI safety is provided in the specifications.

Other devices from Tekka

Questions

AI-generated answers, 23 Sep 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 ORTRAUTEK ORTHOGNATHIC SYSTEM used for?

    This device is a plate and bone system intended for use in orthognathic procedures by dental professionals.

  • Is the ORTRAUTEK ORTHOGNATHIC SYSTEM single-use or reusable?

    The specifications provided do not state whether the device is single-use or reusable.

  • Is the ORTRAUTEK ORTHOGNATHIC SYSTEM sterile?

    The provided specifications do not contain information regarding the sterility of the device.

  • What is the regulatory status of the ORTRAUTEK ORTHOGNATHIC SYSTEM?

    The device is subject to FDA 510(k) clearance.