The TMJ System™ BruxH

GUDID 19330944001688

MYOFUNCTIONAL RESEARCH CORPORATION PTY. LIMITED

Removable dental occlusal splint, preformed

• Primary Device ID: 19330944001688
• NIH Device Record Key: 071e32a8-e548-4917-a534-268920f1ef69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: The TMJ System™
• Version Model Number: Bruxogard Hard
• Catalog Number: BruxH
• Company DUNS: 742030310
• Company Name: MYOFUNCTIONAL RESEARCH CORPORATION PTY. LIMITED
• 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: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	19330944001688 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K924974

FDA Product Code

• KMY: POSITIONER, TOOTH, PREFORMED

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-14
• Device Publish Date: 2025-05-06

On-Brand Devices [The TMJ System™]

• 19330944001749: TMJ-MBV
• 19330944001725: TMD
• 19330944001701: The TMJ Appliance
• 19330944001688: Bruxogard Hard