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TriTanium

by American Orthodontics 61 variants

Ref 859-540, 859-736IW, 859-744IW, 859-554W, 859-738I

Active European Union. Also listed in GUDID (US), partly in commercial distribution.

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number01907460000229E4 Basic UDI-DI Date31 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00190746055690 UDI-DI Date20 Oct 2017ListedStatusListed GUDID: 4 of 5 UDI-DIs in commercial distribution

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
Orthodontic wire
Model / Ref / Catalog
859-540, 859-744IW, 859-554W, 859-736IW, 859-738I
Primary DI / UDI-DI
00190746055690, 00190746029738, 00190746029455, 00190746029615, 00190746056130
Basic UDI-DI
01907460000229E4
FDA Product Code
DZC
EMDN Code
Q010405 Orthodontic wires
GMDN Term
Orthodontic wire
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.5410
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution (UDI-DI 00190746055690, 00190746029738, 00190746029455, 00190746029615)
Not in Commercial Distribution (UDI-DI 00190746056130)
MRI Safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
US-MF-000007702
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from American Orthodontics

See all devices from American Orthodontics →

Properties

  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Manufacturing Date

Other properties (19)

  • 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
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No