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Nickle-Titanium Orthodontic Wire

by American Orthodontics

510(k) K891327

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K891327↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK891327 Date10 May 1989ClearedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K891327 decided 10 May 1989 Active
  • EUDAMED Active

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
FJF
Device class
Class II
Regulation
21 CFR Part 876.5820
Advisory committee
Gastroenterology, Urology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

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

This device is a Nickel-Titanium Orthodontic Wire, classified under orthodontic archwires designed to apply controlled force for tooth alignment. Its superelastic properties allow for gradual, consistent movement of teeth without excessive friction, making it suitable for both fixed and removable orthodontic appliances.

The wire is supplied in sterile, pre-cut lengths for single-use in clinical settings and is regulated under FDA 510K clearance (K891327) and MDR compliance. Available in standard orthodontic sizes, it requires proper handling and storage to maintain sterility, adhering to orthodontic best practices for patient care. No MRI safety restrictions are specified.

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