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Beta Titanium Archwire 228-022

by Ortho Arch Company

Ref 228-022Model .021 X .025 UPPER BETA-T RIGHT FORM ARCHWIRES (10)

Beta Titanium Archwire 228-022 is a device classified as Class IIa in the EU and Class I in the US made by Ortho Arch Company, registered in EUDAMED on 29 Oct 2026 (Basic UDI-DI B-+D90922802213) and listed in FDA GUDID since 17 Jan 2022 (UDI-DI +D90922802213), active as of 8 Nov 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

Valid until

No date given

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

Source EUDAMED, GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-+D90922802213 Basic UDI-DI +D90922802213UDI-DIDate29 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+D90922802213 UDI-DI Date17 Jan 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-+D90922802213 registered 29 Oct 2026 Active
  • FDA GUDID UDI-DI +D90922802213 listed 17 Jan 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID +D90922802213
  2. Registered EUDAMED B-+D90922802213

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
Beta Titanium Archwire
Generic name
Orthodontic archwire
Model / Ref / Catalog
228-022, .021 X .025 UPPER BETA-T RIGHT FORM ARCHWIRES (10)
Primary DI / UDI-DI
+D90922802213 EUDAMED
D90922802213 GUDID
Basic UDI-DI
B-+D90922802213
FDA product code
DZC
EMDN code
Q010405 Orthodontic wires
GMDN term
Orthodontic archwire
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.5410
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+D90922802213
GUDID
D90922802213
Device classEUDAMED
Class IIa
GUDID
Class I

The registries describe this device under different primary UDI-DIs (EUDAMED lists +D90922802213; FDA GUDID lists D90922802213), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Orthodontic archwire

Similar devices in this category

Other devices filed under ORTHODONTIC WIRES.

Other devices from Ortho Arch Company

See all devices from Ortho Arch Company →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)