Duns Number:003530786
Device Description: The Brux-TMD Quicksplint is a patented anterior bite plate that covers the upper or lower 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.
Catalog Number
90000FG
Brand Name
Orofacial Therapeutics
Version/Model Number
90509
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MQC
Product Code Name
Mouthguard, Prescription
Public Device Record Key
4a7eebb9-3732-4860-a73a-f7083e5c362e
Public Version Date
December 21, 2020
Public Version Number
6
DI Record Publish Date
June 01, 2017
Package DI Number
10859290006158
Quantity per Package
12
Contains DI Package
00859290006151
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
INNER BOX
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |