QuickSplint Kit Pouch
The Brux-TMD Quicksplint is a patented anterior bite plate that covers the upper or lower front teeth from bicuspid through bicuspid. It is a two component device with a hard plastic shell…
The Brux-TMD Quicksplint is a patented anterior bite plate that covers the upper or lower front teeth from bicuspid through bicuspid. It is a two component device with a hard plastic shell and a softer compliant lining that conforms to the supporting teeth. The operator may optionally place it on the anterior maxillary or mandibular arch. While it is worn, the Brux-TMD Quicksplint temporarily inhibits the full force of parafunctional teeth clenching, and gives the pericranial musculature and opportunity to relax. This reduces the muscular tension that underlies the pain associated with many bruxism headaches and the pain associated with TMD dysfunction. It reduces the muscle tension in trigeminal innervated cranial-facial muscles, thereby reducing the pain occurrence. In addition, it physically protects the teeth from nighttime bruxing activities by covering the dental occlusal surfaces with a durable plastic covering.
Who Else Makes It
Concentrated in Jiangsu (11), Guangdong (8), Shanghai (4). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Hubei Guarddent Medical Technology Co., Ltd. | Wuhan | Hubei | Manufacturer | 60 |
| Anqing Clean Dental Instrument Technology Co., Ltd. | Anqing | Anhui | Manufacturer | 50 |
| Dongguan Wanjin Industrial Co., Ltd. | Dongguang | Guangdong | Remanufacturer | 41 |
| Tangshan Zhengtong Exhibition Co., Ltd. | Tangshan | Hebei | Manufacturer | 34 |
| Tianjin Water Source Tech Co., Ltd. | Tianjin | Tianjin | Manufacturer | 27 |
Showing 12 of 41. All 41 manufacturers in China registered for Material, Impression Tray, Resin
Record
| Listed by | Truer Medical, Inc., United States |
|---|---|
| FDA product code | EBH |
| Device type | Material, Impression Tray, Resin |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3670 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Record published | 2017-06-01 |
| Record revised | 2020-12-21 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to 60 °C |
| Packaging | Master carton of 16, inner box of 6 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 90525 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| COE® | GC America Inc. | 400 |
| Power Dental USA | Power Dental U.S.A. Inc. | 56 |
| Plasdent | Plasdent Corp. | 41 |
| JMU | JMU Dental, Inc | 40 |
| Vertex-Dental BV | Vertex-Dental B.V. | 34 |
| COE Tray Plastic™ | GC America Inc. | 28 |
| Ou Nuo | Changzhou OU NUO Medical Equipment Co., Ltd. | 28 |
| Excellent | Plasdent Corp. | 22 |
| Shining 3D® | Hangzhou SHINING3D Dental Technology Co., Ltd. | 17 |
| Smart Dent ® | Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. | 17 |
| Britedent | Bright Supply Inc | 16 |
| iSmile | Ismile Dental Products Inc. | 15 |
Showing 12 of 197. All products under Material, Impression Tray, Resin
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.