mmRNA appliance

GUDID 00810002220111

The mmRNA appliance is an intraoral device used for treating snoring and mild to moderate sleep apnea. It consists of either an upper tray, lower tray, or both, and is designed to open the airway during sleep.

JOHN'S DENTAL LABORATORY INC

Custom-made mouthguard

• Primary Device ID: 00810002220111
• NIH Device Record Key: 883827ef-fb0d-492d-8a88-0fc5c8548b72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: mmRNA 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: true
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810002220111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210203

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: 2022-02-14
• Device Publish Date: 2022-02-04