QuickSplint Kit Pouch 90600FG

GUDID 00859290006205

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.

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Primary Device ID00859290006205
NIH Device Record Keyaf9aa019-d3c2-4eba-ba2a-3d9af870fa10
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuickSplint Kit Pouch
Version Model Number90525
Catalog Number90600FG
Company DUNS003530786
Company NameTRUER MEDICAL, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(858) 252 2264
Emailann@quicksplint.com
Phone(858) 252 2264
Emailann@quicksplint.com
Phone(858) 252 2264
Emailann@quicksplint.com
Phone(858) 252 2264
Emailann@quicksplint.com
Phone(858) 252 2264
Emailann@quicksplint.com
Phone(858) 252 2264
Emailann@quicksplint.com
Phone(858) 252 2264
Emailann@quicksplint.com
Phone(858) 252 2264
Emailann@quicksplint.com
Phone(858) 252 2264
Emailann@quicksplint.com
Phone(858) 252 2264
Emailann@quicksplint.com
Phone(858) 252 2264
Emailann@quicksplint.com
Phone(858) 252 2264
Emailann@quicksplint.com
Phone(858) 252 2264
Emailann@quicksplint.com
Phone(858) 252 2264
Emailann@quicksplint.com
Phone(858) 252 2264
Emailann@quicksplint.com
Phone(858) 252 2264
Emailann@quicksplint.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Storage Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100859290006182 [Primary]
GS100859290006199 [Package]
Contains: 00859290006182
Package: INNER BOX [6 Units]
In Commercial Distribution
GS100859290006205 [Package]
Contains: 00859290006199
Package: MASTER CARTON [16 Units]
In Commercial Distribution

FDA Product Code

EBHMaterial, Impression Tray, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2018-09-24
Device Publish Date2017-06-01

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