A custom-made oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is custom-made for a specified patient from impr
| Company | Devices | Share |
|---|---|---|
| Astron Dental Corporation | 39 | 41% |
| Pro3Dure Medical Gmbh | 14 | 15% |
| Dentek Oral Care, Inc. | 11 | 11% |
| Benco Dental Supply Co. | 9 | 9% |
| Splintek Inc. | 5 | 5% |
| Medtech Products Inc. | 4 | 4% |
| Encore Laboratory Llc | 3 | 3% |
| Owl Dental Lab Inc | 3 | 3% |
| Grindguard Inc. | 3 | 3% |
| Keller Laboratories, Inc. | 1 | 1% |
| Slow Wave, Inc. | 1 | 1% |
| Selane Products, Inc. | 1 | 1% |
Company = labeler of record on GUDID. 14 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 |
|---|---|---|
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 33 |
| MQC | Mouthguard, Prescription | 32 |
| OBR | Mouthguard, Over-The-Counter | 30 |
| EBH | Material, Impression Tray, Resin | 9 |
| OCO | Mouthguard, Migraine/Tension Headache | 7 |
| EBI | RESIN, DENTURE, RELINING, REPAIRING, REBASING | 5 |
Use these as the dimensions to specify in a tender line.
96 device records in commercial distribution are listed on the FDA Global Unique Device Identification Database (GUDID) under the GMDN category "Custom-made mouthguard", from 14 companies. The largest labeler is Astron Dental Corporation with 41% of records.
EBI (Resin, Denture, Relining, Repairing, Rebasing), MQC (Mouthguard, Prescription), OBR (Mouthguard, Over-The-Counter), EBH (Material, Impression Tray, Resin)
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.