An orthodontic appliance, bonded or removable, intended to be used on a single patient to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance, also referred to as a positioner, is also
| Company | Devices | Share |
|---|---|---|
| Leone Spa | 370 | 20% |
| Micerium Spa | 284 | 15% |
| Tp Orthodontics Inc | 202 | 11% |
| Myofunctional Research Corporation Pty. Limited | 182 | 10% |
| Lm-Dental | 163 | 9% |
| Eptamed Srl | 100 | 5% |
| Ortho-Tain, Inc | 98 | 5% |
| Five Star Orthodontic Laboratory & Supply Inc | 51 | 3% |
| Digital Dental Laboratories, Inc | 51 | 3% |
| 3M Unitek Corporation | 42 | 2% |
| Rmo, Inc. | 40 | 2% |
| Gc Orthodontics America Inc. | 39 | 2% |
Company = labeler of record on GUDID. 51 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 |
|---|---|---|
| KMY | Positioner, Tooth, Preformed | 594 |
| DYJ | Retainer, Screw Expansion, Orthodontic | 471 |
| KMY | POSITIONER, TOOTH, PREFORMED | 324 |
| JEX | Plier, Orthodontic | 295 |
| DYJ | RETAINER, SCREW EXPANSION, ORTHODONTIC | 132 |
| DYO | Band, Material, Orthodontic | 86 |
Use these as the dimensions to specify in a tender line.
1,876 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthodontic retainer", from 51 companies. The largest labeler is Leone Spa with 20% of records.
KMY (Positioner, Tooth, Preformed), DYJ (Retainer, Screw Expansion, Orthodontic), KMY (POSITIONER, TOOTH, PREFORMED), JEX (Plier, 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.