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Nickel Titanium Orthodontic Archwire

by Ultimate Wireforms, Inc. 341 variants

Ref NTARC

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

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

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K924805↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number50563856NTARC01123 Basic UDI-DI Date28 Apr 2026RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK924805 Date31 Mar 1993IssuedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

Device Name
niti archwire
Model / Reference
NTARC
Primary DI / UDI-DI
05056385613675, 05056385612319, 05056385603997, 05056385605557, 05056385616539, 05056385615686, 05056385604611, 05056385612494, 05056385602020, 05056385612685, 05056385615976, 05056385610230, 05056385614931, 05056385612227, 05056385603768, 05056385611183, 05056385615143, 05056385616225, 05056385603133, 05056385610247, 05056385606042, 05056385614740, 05056385606059, 05056385610193, 05056385609951, 05056385608817, 05056385605892, 05056385612272, 05056385609814, 05056385610452, 05056385615570, 05056385611534, 05056385615297, 05056385601801, 05056385603867, 05056385611923, 05056385609784, 05056385603621, 05056385615693, 05056385601108, 05056385601450, 05056385606721, 05056385605328, 05056385613538, 05056385613989, 05056385612029, 05056385605564, 05056385608411, 05056385614894, 05056385608312
Basic UDI-DI
50563856NTARC01123
EMDN Code
Q010405 Orthodontic wires
Device Class
Class IIa
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000013501
Authorised representative
MedEnvoy Global BV NL-AR-000024028

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Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No