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Device Explorer · FDA GUDID · GMDN 38734

Orthodontic metal band

A thin metal ring designed to be fitted around the contours of a tooth and cemented into place to support an orthodontic attachment (e.g., bracket, tube), brazed or soldered onto the ring, intended to be secured to the tooth. This is a single-patient device in

US‑registered devices36,770in commercial distribution
Companies27labelers on GUDID
Single‑use100%of device records
Sterile0%labelled sterile
Prescription98%Rx‑only share
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Share of device records

Ortho Organizers, Inc.9,35525%
Forestadent Bernhard Förster Gmbh8,64624%
Ortho Technology, Inc.4,86313%
Leone Spa2,5497%
American Orthodontics Corporation2,0996%
3M Unitek Corporation1,9205%
Young Innovations, Inc.1,4874%
Dentaurum Gmbh & Co.Kg1,4434%

Top labelers

CompanyDevicesShare
Ortho Organizers, Inc.9,35525%
Forestadent Bernhard Förster Gmbh8,64624%
Ortho Technology, Inc.4,86313%
Leone Spa2,5497%
American Orthodontics Corporation2,0996%
3M Unitek Corporation1,9205%
Young Innovations, Inc.1,4874%
Dentaurum Gmbh & Co.Kg1,4434%
Ormco Corporation1,3134%
Ortho Arch Company Inc6522%
Gc Orthodontics America Inc.5952%
Rmo, Inc.3781%

Company = labeler of record on GUDID. 27 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

meitedentalDTCN.A.A-FIT®SURE-SNAPOrmcoMiscUltralockAdvanSync 2TrimlineUltimaxUltimaWashbonORTHODONTIC CUSTOM BANDSTruformHALO MOLAR BAND

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

FDA product codes

CodeNameDevices
ECMBAND, PREFORMED, ORTHODONTIC32,316
ECMBand, Preformed, Orthodontic3,426
DYOBAND, MATERIAL, ORTHODONTIC918
ECIBand, Elastic, Orthodontic786
ECNClamp, Wire, Orthodontic207
DYOBand, Material, Orthodontic133

GMDN & GCC registration

  • GMDN code 38734 · non‑implantable
  • Single‑use 100% · sterile 0% · Rx‑only 98% · 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 (Millimeter) · 2Length (Millimeter) · 1

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

How many orthodontic metal band products are registered in the US?

36,770 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthodontic metal band", from 27 companies. The largest labeler is Ortho Organizers, Inc. with 25% of records.

Which FDA product codes apply?

ECM (BAND, PREFORMED, ORTHODONTIC), ECM (Band, Preformed, Orthodontic), DYO (BAND, MATERIAL, ORTHODONTIC), ECI (Band, Elastic, 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.

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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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