The Luco Hybrid OSA Appliance

GUDID 00810002220241

An intraoral device designed to treat primary snoring and mild to moderate obstructive sleep apnea, as well as sleep bruxism and aid in the treatment of associated tension/migraine type headaches in adults. This device is reusable.

JOHN'S DENTAL LABORATORY INC

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: 00810002220241
• NIH Device Record Key: da13e98e-a445-46e6-86dd-17b193263aae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: The Luco Hybrid OSA Appliance
• Version Model Number: 3014680794
• Company DUNS: 016649253
• Company Name: JOHN'S DENTAL LABORATORY 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	00810002220241 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130797

FDA Product Code

• LRK: Device, Anti-Snoring

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-05
• Device Publish Date: 2023-03-28