Orofacial Therapeutics 90000FG

GUDID 00859290006151

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.

TRUER MEDICAL, INC.

Mouthguard, reusable

• Primary Device ID: 00859290006151
• NIH Device Record Key: 4a7eebb9-3732-4860-a73a-f7083e5c362e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Orofacial Therapeutics
• Version Model Number: 90509
• Catalog Number: 90000FG
• Company DUNS: 003530786
• Company Name: TRUER MEDICAL, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (858) 252-2264
• Email: ann@quicksplint.com
• Phone: (858) 252-2264
• Email: ann@quicksplint.com
• Phone: (858) 252-2264
• Email: ann@quicksplint.com
• Phone: (858) 252-2264
• Email: ann@quicksplint.com
• Phone: (858) 252-2264
• Email: ann@quicksplint.com
• Phone: (858) 252-2264
• Email: ann@quicksplint.com
• Phone: (858) 252-2264
• Email: ann@quicksplint.com
• Phone: (858) 252-2264
• Email: ann@quicksplint.com
• Phone: (858) 252-2264
• Email: ann@quicksplint.com
• Phone: (858) 252-2264
• Email: ann@quicksplint.com
• Phone: (858) 252-2264
• Email: ann@quicksplint.com
• Phone: (858) 252-2264
• Email: ann@quicksplint.com
• Phone: (858) 252-2264
• Email: ann@quicksplint.com
• Phone: (858) 252-2264
• Email: ann@quicksplint.com
• Phone: (858) 252-2264
• Email: ann@quicksplint.com
• Phone: (858) 252-2264
• Email: ann@quicksplint.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859290006151 [Primary]
GS1	10859290006158 [Package]; Package: INNER BOX [12 Units]; In Commercial Distribution
GS1	20859290006155 [Package]; Contains: 10859290006158; Package: MASTER CASE [12 Units]; In Commercial Distribution
GS1	30859290006152 [Package]; Package: CASE [100 Units]; In Commercial Distribution

FDA Product Code

• MQC: Mouthguard, Prescription

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-09-24
• Device Publish Date: 2017-06-01

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