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 has an integral fixation clip, typically made of a polymer with a metal hinge, to retain the a
| Company | Devices | Share |
|---|---|---|
| American Orthodontics Corporation | 251 | 28% |
| Gni Co.,Ltd | 126 | 14% |
| Leone Spa | 104 | 12% |
| Orthometric - Industria E Comercio De Produtos Medicos E Odontologicos Ltda | 103 | 12% |
| Aditek Do Brasil S/A | 84 | 10% |
| Ortho Organizers, Inc. | 72 | 8% |
| Ortho Arch Company Inc | 66 | 7% |
| Dental Morelli Ltda | 59 | 7% |
| The Atlanta Dental Supply Company | 16 | 2% |
| Hangzhou Dtc Medical Apparatus Co., Ltd. | 3 | 0% |
Company = labeler of record on GUDID. 10 companies in total; top 12 shown. Click headers to sort.
Sample of brand names as labelled; no endorsement. Ask us for the full list with company, model and UDI.
| Code | Name | Devices |
|---|---|---|
| NJM | Bracket, ceramic, orthodontic | 853 |
| NJM | Bracket, Ceramic, Orthodontic | 296 |
| EJF | Bracket, Metal, Orthodontic | 271 |
| EJF | BRACKET, METAL, ORTHODONTIC | 50 |
| ECQ | Aligner, Bracket, Orthodontic | 2 |
| ECI | Band, Elastic, Orthodontic | 2 |
Use these as the dimensions to specify in a tender line.
884 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Self-ligating orthodontic bracket", from 10 companies. The largest labeler is American Orthodontics Corporation with 28% of records.
NJM (Bracket, ceramic, orthodontic), NJM (Bracket, Ceramic, Orthodontic), EJF (Bracket, Metal, Orthodontic), EJF (BRACKET, METAL, ORTHODONTIC)
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.