An orthodontic device intended to gradually spread the maxillary arch and/or improve teeth alignment. It is typically in the form of either: 1) a segmented body separated by a palate expander screw; or 2) a spring-like mechanism with clasps and/or wires. It is
| Company | Devices | Share |
|---|---|---|
| Orthosource | 90 | 42% |
| Dentaurum Gmbh & Co.Kg | 75 | 35% |
| Five Star Orthodontic Laboratory & Supply Inc | 31 | 14% |
| Allesee Aoa-Pro | 12 | 6% |
| Digital Dental Laboratories, Inc | 3 | 1% |
| Boss Instruments, Ltd., Inc. | 2 | 1% |
| Align Technology, Inc. | 2 | 1% |
| Great Lakes Dental Technologies, Ltd. | 1 | 0% |
Company = labeler of record on GUDID. 8 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 |
|---|---|---|
| DYJ | Retainer, Screw Expansion, Orthodontic | 141 |
| KMY | POSITIONER, TOOTH, PREFORMED | 87 |
| DYJ | RETAINER, SCREW EXPANSION, ORTHODONTIC | 9 |
| DZC | Wire, Orthodontic | 4 |
| EIG | RETRACTOR, ALL TYPES | 2 |
| NXC | Aligner, Sequential | 2 |
Use these as the dimensions to specify in a tender line.
216 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthodontic palate expander/teeth aligner, self-removable", from 8 companies. The largest labeler is Orthosource with 42% of records.
DYJ (Retainer, Screw Expansion, Orthodontic), KMY (POSITIONER, TOOTH, PREFORMED), DYJ (RETAINER, SCREW EXPANSION, ORTHODONTIC), DZC (Wire, 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.