A rigid or flexible custom-made device intended to overlay the occlusal surfaces of the teeth to maintain the position of displaced or moveable teeth, to treat teeth clenching and bruxism and their sequelae, and to provide temporary relief from muscle or tempo
| Company | Devices | Share |
|---|---|---|
| Merz Dental Gmbh | 28 | 30% |
| Detax Gmbh | 15 | 16% |
| Vertex-Dental B.V. | 12 | 13% |
| Allesee Aoa-Pro | 9 | 10% |
| Materialise Nv | 5 | 5% |
| Primotec Llc | 4 | 4% |
| Envisiontec Gmbh | 3 | 3% |
| Ultradent Products, Inc. | 3 | 3% |
| Benco Dental Supply Co. | 3 | 3% |
| Deltamed Gmbh | 2 | 2% |
| Five Star Orthodontic Laboratory & Supply Inc | 2 | 2% |
| Pro3Dure Medical Gmbh | 2 | 2% |
Company = labeler of record on GUDID. 17 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 |
|---|---|---|
| MQC | Mouthguard, Prescription | 50 |
| DYJ | Retainer, Screw Expansion, Orthodontic | 15 |
| KMY | Positioner, Tooth, Preformed | 14 |
| KMY | POSITIONER, TOOTH, PREFORMED | 12 |
| DYT | Maintainer, Space Preformed, Orthodontic | 7 |
| EBH | MATERIAL, IMPRESSION TRAY, RESIN | 7 |
Use these as the dimensions to specify in a tender line.
No closely related category with 50+ devices.
93 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Removable dental occlusal splint, custom-made", from 17 companies. The largest labeler is Merz Dental Gmbh with 30% of records.
MQC (Mouthguard, Prescription), DYJ (Retainer, Screw Expansion, Orthodontic), KMY (Positioner, Tooth, Preformed), KMY (POSITIONER, TOOTH, PREFORMED)
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.