Consulting Wallah › Device Explorer › Other devices › Orthodontic bracket, metal
Device Explorer · FDA GUDID · GMDN 46581

Orthodontic bracket, metal

A metallic device that is bonded to an orthodontic band, or directly to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient d

US‑registered devices33,928in commercial distribution
Companies49labelers on GUDID
Single‑use99%of device records
Sterile0%labelled sterile
Prescription93%Rx‑only share
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Share of device records

Forestadent Bernhard Förster Gmbh5,91717%
American Orthodontics Corporation4,90214%
3M Unitek Corporation4,05112%
Gc Orthodontics America Inc.2,6648%
Leone Spa2,2197%
Ortho Organizers, Inc.1,7945%
Ormco Corporation1,7785%
Rmo, Inc.1,5124%

Top labelers

CompanyDevicesShare
Forestadent Bernhard Förster Gmbh5,91717%
American Orthodontics Corporation4,90214%
3M Unitek Corporation4,05112%
Gc Orthodontics America Inc.2,6648%
Leone Spa2,2197%
Ortho Organizers, Inc.1,7945%
Ormco Corporation1,7785%
Rmo, Inc.1,5124%
Dentaurum Gmbh & Co.Kg1,2424%
Tp Orthodontics Inc1,1703%
Young Innovations, Inc.1,0203%
3M Do Brasil Ltda.9493%

Company = labeler of record on GUDID. 49 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

Convertible Buccal Tube KitPatient Transfer KitSorted BracketsSPEED Convertible Buccal TubeSPEED Buccal Tube SamplesSPEED Buccal TubeSPEED BracketmeitedentalGlambEKSENInbracket, Customized Lingual BracketInbracket, Customized Lingual Self-ligating BracDTCEaster Self-Ligating Bracket,.022 Roth,#3,4,5w/hEaster Self-Ligating Bracket,.022 Roth, #3 w/hsThino Roth Bracket,.022, Mini Size, w/hs at #3,4

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

FDA product codes

CodeNameDevices
EJFBRACKET, METAL, ORTHODONTIC28,973
EJFBracket, Metal, Orthodontic7,082
DYHADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN2,588
DZDTUBE, ORTHODONTIC732
ECMBAND, PREFORMED, ORTHODONTIC691
NJMBracket, Ceramic, Orthodontic342

GMDN & GCC registration

  • GMDN code 46581 · non‑implantable
  • Single‑use 99% · sterile 0% · Rx‑only 93% · 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

Length (Millimeter) · 4Length (Inch) · 2Width (Millimeter) · 1

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

How many orthodontic bracket, metal products are registered in the US?

33,928 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthodontic bracket, metal", from 49 companies. The largest labeler is Forestadent Bernhard Förster Gmbh with 17% of records.

Which FDA product codes apply?

EJF (BRACKET, METAL, ORTHODONTIC), EJF (Bracket, Metal, Orthodontic), DYH (ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN), DZD (TUBE, 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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