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Nickel Titanium Orthodontic Wire, Ultra Therm Optima Archwires

by Ultimate Wireforms, Inc. 3 variants

Ref NTARC, NTSPL, NTSTR

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number50563856NTARC01123 Basic UDI-DI Date28 Apr 2026RegisteredStatusActive

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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Trade Name
Nickel Titanium Orthodontic Wire, Ultra Therm Optima Archwires
Nickel Titanium Orthodontic Wire
Device Name
niti archwire
niti spool wire
niti straight wire
Model / Reference
NTARC, NTSPL, NTSTR
Primary DI / UDI-DI
05056385602822, 05056385602617, 05056385602679, 05056385602402, 05056385602518, 05056385602228, 05056385602914, 05056385602501, 05056385602747, 05056385602389, 05056385602808, 05056385602662, 05056385602686, 05056385602280, 05056385602877, 05056385616898, 05056385602624, 05056385602556, 05056385616737, 05056385602563, 05056385616904, 05056385602365, 05056385602327, 05056385602594, 05056385602860, 05056385602303, 05056385602310, 05056385602853, 05056385602259, 05056385602419, 05056385602587, 05056385602266, 05056385602242, 05056385602334, 05056385602440, 05056385602693, 05056385602341, 05056385602938, 05056385602426, 05056385616874, 05056385602839, 05056385602570, 05056385602761, 05056385602907, 05056385602815, 05056385602396, 05056385602372, 05056385602792, 05056385616744, 05056385602464
Basic UDI-DI
50563856NTARC01123, 50563856NTSPL013AS, 50563856NTSTR012DE
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

Other devices from Ultimate Wireforms, Inc.

See all devices from Ultimate Wireforms, Inc. →

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