Orofacial Therapeutics
- Primary DI
- 00859290006151
- Brand
- Orofacial Therapeutics
- Company
- TRUER MEDICAL, INC.
- Model
- 90509
- Catalog number
- 90000FG
- Device description
- 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.
- Published
- 2017-06-01
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Single use
- true
Contact Domains#
Product Codes#
| Code | Name |
|---|---|
| MQC | Mouthguard, Prescription |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| MQC | Mouthguard, Prescription | Unknown | U |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 10859290006158 | Package | GS1 | 12 | In Commercial Distribution |
| 20859290006155 | Package | GS1 | 12 | In Commercial Distribution |
| 30859290006152 | Package | GS1 | 100 | In Commercial Distribution |
| 00859290006151 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 10859290006158 | 10859290006158 | ||
| 20859290006155 | 20859290006155 | ||
| 30859290006152 | 30859290006152 | ||
| 00859290006151 | 00859290006151 | 859290006151 | 0859290006151 |
GMDN Terms#
| Term | Definition |
|---|---|
| Mouthguard, reusable | A prefabricated 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 made of standard, preformed materials or items for adaptation to/direct insertion into the mouth; some types are referred to as nightguards or bite raising appliances. This is a reusable device intended for single-patient use. |
Storage And Handling#
| Type | Low | High | Condition |
|---|---|---|---|
| Storage Environment Temperature | 0 Degrees Celsius | 60 Degrees Celsius |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| (858) 252-2264 | ann@quicksplint.com |
| (714) 628-9785 | ttruitt@truermedical.com |
| (714) 628-9785 | cpescador@truermedical.com |
| (714) 628-9785 | ctruitt@truermedical.com |
Regulatory Flags#
- DUNS number
- 003530786
- Device count
- 1
- Lot or batch
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00859290006489 | Sharn by Marketlab | Sharn SSP-400 | 2024-10-29 | |
| 10859290006486 | Sharn by Marketlab | Sharn SSP-400 | 2024-10-29 | |
| 00859290006472 | HP to 3.5mm Phonojack Cable with Shrinkwrap | 70309 | 70309 | 2024-01-16 |
| 00859290006465 | Truer Bougie Coiled | 90553 | 2023-09-22 | |
| 10859290006462 | Truer Bougie Coiled | 90553 | 2023-09-22 | |
| 00859290006441 | 400 Series Right Angle Cable (80 cm) | 70323 | 2023-07-19 | |
| 00859290006458 | 400 Series Right Angle Cable (160 cm) | 70326 | 2023-07-19 | |
| 00859290006359 | Pediatric Stylet | 90201 | 90201 | 2022-06-30 |
| 00859290006342 | Adult Stylet | 90200 | 90200 | 2022-06-30 |
| 00859290006434 | CO EX LINE 96'X.048'X112' M/M | 90116 | 90116 | 2022-12-09 |
| 00859290006410 | Nasal Cannula | 90413 | 90413 | 2022-09-08 |
| 10859290006417 | Nasal Cannula | 90413 | 90413 | 2022-09-08 |
| 00859290006236 | Truer Bougie | 90552 | 2022-08-29 | |
| 00859290006274 | Gas Sampling Line 120'x.048'x.108' M/F | 90101 | 90101 | 2022-06-30 |
| 00859290006281 | Gas Sampling Line 120'x.040'x.112' M/M | 90148 | 90148 | 2022-06-30 |
| 00859290006298 | Gas Sampling Line 120'X.050'x.108' M/M | 90150 | 90150 | 2022-06-30 |
| 00859290006304 | GAS SAMPLING LINE 120'x.050'x.108' M/F | 90151 | 90151 | 2022-06-30 |
| 00859290006311 | GAS SAMPLING LINE 96'x.050'x.112' MM | 90156 | 90156 | 2022-06-30 |
| 00859290006328 | GAS SAMPLING LINE 120' X .050' X .112' M/M | 90158 | 90158 | 2022-06-30 |
| 00859290006267 | Gas Sampling Line 120 x .048 x .108 M/M CO-EX | 90100 | 90100 | 2022-06-30 |
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