A custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function of the stomatognathic system to correct malocclusions (e.g., underbites, overb
| Company | Devices | Share |
|---|---|---|
| Ortho Organizers, Inc. | 688 | 62% |
| Specialty Appliances, Llc | 69 | 6% |
| Henry Schein, Inc. | 55 | 5% |
| 3M Unitek Corporation | 53 | 5% |
| Align Technology, Inc. | 30 | 3% |
| Ormco Corporation | 16 | 1% |
| Access Dental Lab, Llc | 16 | 1% |
| Candid Care Co. | 16 | 1% |
| Park Dental Research Corp | 15 | 1% |
| Solventum Orthodontics Corporation | 13 | 1% |
| Wuxi Ea Medical Instruments Technologies Limited. | 11 | 1% |
| Zhejiang Yinchili Medical Technology Co., Ltd. | 10 | 1% |
Company = labeler of record on GUDID. 59 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 |
|---|---|---|
| NXC | Aligner, sequential | 949 |
| NXC | Aligner, Sequential | 314 |
| KMY | Positioner, Tooth, Preformed | 22 |
| DYT | Maintainer, Space Preformed, Orthodontic | 11 |
| EIF | Accessories, Retractor, Dental | 4 |
| DYW | Bracket, Plastic, Orthodontic | 2 |
Use these as the dimensions to specify in a tender line.
1,109 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Orthodontic progressive aligner", from 59 companies. The largest labeler is Ortho Organizers, Inc. with 62% of records.
NXC (Aligner, sequential), NXC (Aligner, Sequential), KMY (Positioner, Tooth, Preformed), DYT (Maintainer, Space Preformed, 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.