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Device Explorer · FDA GUDID · GMDN 41397

Orthodontic archwire

A dental wire in the shape of an arch used with orthodontic attachments (orthodontic brackets) that are affixed to the crowns/surfaces of two or more teeth in order to cause/guide tooth movement. This is a single-patient device intended to be used for the dura

US‑registered devices31,347in commercial distribution
Companies47labelers on GUDID
Single‑use99%of device records
Sterile0%labelled sterile
Prescription97%Rx‑only share
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Share of device records

G & H Wire Company, Inc.18,90360%
Ormco Corporation1,1864%
Ortho Organizers, Inc.1,0483%
Young Innovations, Inc.1,0363%
Ortho Arch Company Inc1,0173%
3M Unitek Corporation9453%
Dentos Inc.7112%
World Class Technology Corporation6682%

Top labelers

CompanyDevicesShare
G & H Wire Company, Inc.18,90360%
Ormco Corporation1,1864%
Ortho Organizers, Inc.1,0483%
Young Innovations, Inc.1,0363%
Ortho Arch Company Inc1,0173%
3M Unitek Corporation9453%
Dentos Inc.7112%
World Class Technology Corporation6682%
Rmo, Inc.6652%
Ortho Technology, Inc.5622%
Leone Spa5612%
Acme Monaco Corporation5412%

Company = labeler of record on GUDID. 47 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

SPEED Tubular Supercable KitSPEED Supercable KitSPEED Tubular SupercableSPEED Lingual SupercableSPEED SupercableSPEED Wire - Stainless SteelSPEED Wire - Nickel TitaniumRound Nickel Titanium ArchwireHills Dual-Geometry WireSPEED D-Wire - Stainless SteelSPEED D-Wire - Nickel TitaniumSPEED Coaxial ArchwireSPEED Beta Titanium ArchwireMeitedentalDTCSmart

Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.

FDA product codes

CodeNameDevices
DZCWIRE, ORTHODONTIC26,975
DZCWire, Orthodontic5,480
DZDTube, Orthodontic131
DYTMaintainer, Space Preformed, Orthodontic61
DYJRetainer, Screw Expansion, Orthodontic36
EJFBRACKET, METAL, ORTHODONTIC20

GMDN & GCC registration

  • GMDN code 41397 · non‑implantable
  • Single‑use 99% · sterile 0% · Rx‑only 97% · OTC 0%
  • UAE: MOHAP / DoH medical device registration and an authorised representative are required; Saudi: SFDA MDMA. We check status on request.

Size attributes recorded

Width (Inch) · 12,374Height (Inch) · 12,374Outer Diameter (Inch) · 7,043Length (Inch) · 222Length (Feet) · 3Length (Millimeter) · 1

Use these as the dimensions to specify in a tender line.

How many orthodontic archwire products are registered in the US?

31,347 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthodontic archwire", from 47 companies. The largest labeler is G & H Wire Company, Inc. with 60% of records.

Which FDA product codes apply?

DZC (WIRE, ORTHODONTIC), DZC (Wire, Orthodontic), DZD (Tube, Orthodontic), DYT (Maintainer, Space Preformed, Orthodontic)

Is this the same as UAE/GCC registration?

No. GUDID is the US register. For the UAE (MOHAP/DoH) and Saudi (SFDA/MDMA) a separate registration and a local authorised representative are required; Consulting Wallah can check the status and connect you with registered suppliers.

How do I get quotes?

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Source: FDA AccessGUDID (AccessGUDID full release 2 Nov 2026); counts are device records in commercial distribution grouped by GMDN preferred term; companies are labelers of record. Information only — US listing is not a registration in the UAE or GCC; verify with the regulator. © Consulting Wallah — CC BY‑NC‑ND.

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