SleepRight

GUDID 00692121035216

SleepRight ProRx Custom-Fit Dental Guard is indicated for the protection against bruxism or nighttime teeth grinding. It is intended to reduce damage to the teeth and to prevent the noise associated with bruxing or grinding.

Splintek Inc.

Custom-made mouthguard Custom-made mouthguard Custom-made mouthguard Custom-made mouthguard Custom-made mouthguard Custom-made mouthguard Custom-made mouthguard Custom-made mouthguard Custom-made mouthguard Custom-made mouthguard Custom-made mouthguard Custom-made mouthguard Custom-made mouthguard Custom-made mouthguard Custom-made mouthguard

• Primary Device ID: 00692121035216
• NIH Device Record Key: d7e55952-4520-41be-b43e-21354c82dfde
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SleepRight
• Version Model Number: ProRx
• 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: true

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
• Phone: 888-792-0865
• Email: support@splintek.com
• Phone: 888-792-0865
• Email: support@splintek.com
• Phone: 888-792-0865
• Email: support@splintek.com
• Phone: 888-792-0865
• Email: support@splintek.com
• Phone: 888-792-0865
• Email: support@splintek.com
• Phone: 888-792-0865
• Email: support@splintek.com
• Phone: 888-792-0865
• Email: support@splintek.com
• Phone: 888-792-0865
• Email: support@splintek.com
• Phone: 888-792-0865
• Email: support@splintek.com
• 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	00692121035216 [Primary]

FDA Product Code

• OBR: Mouthguard, Over-The-Counter

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: 2023-09-07
• Device Publish Date: 2023-08-30