Orofacial Therapeutics

Basic Information

• Brand Name: Orofacial Therapeutics
• Primary DI: 00859290006151
• Version / Model: 90509
• Catalog Number: 90000FG
• Company Name: TRUER MEDICAL, INC.
• Labeler DUNS: 003530786
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-06-01
• Public Version: 6
• Public Version Date: 2020-12-21
• Public Version Status: Update
• Public Device Record Key: 4a7eebb9-3732-4860-a73a-f7083e5c362e

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.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
MQC	Mouthguard, Prescription	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
38621	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 endoscopic diagnostic procedures, 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00859290006151	GS1
Package	10859290006158	GS1	INNER BOX	12	In Commercial Distribution
Package	20859290006155	GS1	MASTER CASE	12	In Commercial Distribution
Package	30859290006152	GS1	CASE	100	In Commercial Distribution

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: – 60 Degrees Celsius