QuickSplint Kit Pouch

FDA UDI

Class I (US FDA UDI)

by Truer Medical, Inc.

Identity

Trade Name: QuickSplint Kit Pouch FDA UDI
Generic Name: Mouthguard, reusable FDA UDI
Device Name: 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. FDA UDI
Model / Reference: 90525 FDA UDI
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. FDA UDI

Identifiers

Catalog Number: 90600FG FDA UDI
Primary DI / UDI-DI: 00859290006182 FDA UDI
FDA Product Code: EBH FDA UDI
MQC FDA UDI
GES FDA UDI
GMDN Term: Mouthguard, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 872.3670 FDA UDI
878.4800 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Mouthguard, reusable

QuickSplint Kit Pouch by Truer Medical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Mouthguard, reusable.

PMMA BLOCK — Huliang(Shanghai) Biotech Co., Ltd. · U
PMMA BLOCK — SHANDONG HUGE DENTAL MATERIAL CORPORATION · U
PMMA BLOCK — Huliang(Shanghai) Biotech Co., Ltd. · Class II
Nylon Nightguard/Occlusal Appliance — SERENA SLEEP SOLUTIONS LLC · U
PMMA BLOCK — SHANDONG HUGE DENTAL MATERIAL CORPORATION · U
PMMA BLOCK — SHANDONG HUGE DENTAL MATERIAL CORPORATION · U
PMMA BLOCK — Huliang(Shanghai) Biotech Co., Ltd. · U
AESCULAP — AESCULAP, INC. · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Truer Medical, Inc.

Sources (1)

FDA UDI af9aa019-d3c2-4eba-ba2a-3d9af870fa10 36 fields · synced Jun 1, 2026