Consulting Wallah › Device Explorer › Other devices › Orthodontic bracket, ceramic
Device Explorer · FDA GUDID · GMDN 58937

Orthodontic bracket, ceramic

A ceramic device intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. It typically has a metal (e.g., stainless steel) insert slot for the archwire, which is held in p

US‑registered devices8,650in commercial distribution
Companies31labelers on GUDID
Single‑use100%of device records
Sterile0%labelled sterile
Prescription89%Rx‑only share
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Share of device records

Forestadent Bernhard Förster Gmbh1,59418%
3M Unitek Corporation98811%
Gc Orthodontics America Inc.85410%
Tp Orthodontics Inc6938%
G & H Wire Company, Inc.6758%
Flexmedics6017%
Ortho Organizers, Inc.5206%
Orthometric - Industria E Comercio De Produtos Medicos E Odontologicos Ltda3574%

Top labelers

CompanyDevicesShare
Forestadent Bernhard Förster Gmbh1,59418%
3M Unitek Corporation98811%
Gc Orthodontics America Inc.85410%
Tp Orthodontics Inc6938%
G & H Wire Company, Inc.6758%
Flexmedics6017%
Ortho Organizers, Inc.5206%
Orthometric - Industria E Comercio De Produtos Medicos E Odontologicos Ltda3574%
Rmo, Inc.2713%
American Orthodontics Corporation2323%
Ultradent Products, Inc.2273%
Ortho Technology, Inc.2102%

Company = labeler of record on GUDID. 31 companies in total; top 12 shown. Click headers to sort.

Brand names on the register (sample)

DTCN.A.GLAM®QuicKlear®QuicKlearTruKlear®TruKlearTruKLearChicExperienceSymetri ClearInsigniaInspire ICEDamon Clear2DamonDamon Clear

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

FDA product codes

CodeNameDevices
NJMBracket, ceramic, orthodontic5,522
NJMBracket, Ceramic, Orthodontic3,265
EJFBRACKET, METAL, ORTHODONTIC1,265
DYWBRACKET, PLASTIC, ORTHODONTIC118
DYHADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN109
ECQAligner, Bracket, Orthodontic2

GMDN & GCC registration

  • GMDN code 58937 · non‑implantable
  • Single‑use 100% · sterile 0% · Rx‑only 89% · 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

Height (Inch) · 388

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

8,650 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthodontic bracket, ceramic", from 31 companies. The largest labeler is Forestadent Bernhard Förster Gmbh with 18% of records.

Which FDA product codes apply?

NJM (Bracket, ceramic, orthodontic), NJM (Bracket, Ceramic, Orthodontic), EJF (BRACKET, METAL, ORTHODONTIC), DYW (BRACKET, PLASTIC, 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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