SleepRight

GUDID 00692121035513

SleepRight Snore Aid is intended for use by adult patients 18 years of age or older as an aid for the reduction of snoring.

Splintek Inc.

Mandible-repositioning sleep-disordered breathing orthosis

• Primary Device ID: 00692121035513
• NIH Device Record Key: 9d6ceac6-4738-41be-91db-d79504712ff7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SleepRight
• Version Model Number: Snore Aid
• Company DUNS: 171967797
• Company Name: Splintek 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-792-0865
• Email: support@splintek.com
• Phone: 888-792-0865
• Email: support@splintek.com
• Phone: 888-792-0865
• Email: support@splintek.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00692121035513 [Primary]

FDA Product Code

• LRK: Device, Anti-Snoring

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: 2025-12-25
• Device Publish Date: 2025-12-17

On-Brand Devices [SleepRight]

• 00692121035216: SleepRight ProRx Custom-Fit Dental Guard is indicated for the protection against bruxism or nigh
• 00692121035513: SleepRight Snore Aid is intended for use by adult patients 18 years of age or older as an aid fo
• 00692121035438: The SleepRight Select-Comfort Dental Guard is indicated for the protection against bruxism or ni
• 00692121032246: The SleepRight Dura-Comfort Dental Guard is indicated for the protection against bruxism or nigh
• 00692121032062: The SleepRight Ultra-Comfort Dental Guard is indicated for the protection against bruxism or nig
• 00692121032055: The SleepRight Secure-Comfort Dental Guard is indicated for the protection against bruxism or ni