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| 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 |
| support@splintek.com | |
| Phone | 888-792-0865 |
| support@splintek.com | |
| Phone | 888-792-0865 |
| support@splintek.com | |
| Phone | 888-792-0865 |
| support@splintek.com | |
| Phone | 888-792-0865 |
| support@splintek.com | |
| Phone | 888-792-0865 |
| support@splintek.com | |
| Phone | 888-792-0865 |
| support@splintek.com | |
| Phone | 888-792-0865 |
| support@splintek.com | |
| Phone | 888-792-0865 |
| support@splintek.com | |
| Phone | 888-792-0865 |
| support@splintek.com | |
| Phone | 888-792-0865 |
| support@splintek.com | |
| Phone | 888-792-0865 |
| support@splintek.com | |
| Phone | 888-792-0865 |
| support@splintek.com | |
| Phone | 888-792-0865 |
| support@splintek.com | |
| Phone | 888-792-0865 |
| 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 |
Trademark Results [SleepRight]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SLEEPRIGHT 98661144 not registered Live/Pending |
Brown Innovation, LLC 2024-07-22 |
 SLEEPRIGHT 78653229 3681502 Live/Registered |
BROWN INNOVATION, LLC 2005-06-17 |
 SLEEPRIGHT 77274104 not registered Dead/Abandoned |
WhiteDove Herbals, Inc. 2007-09-07 |
 SLEEPRIGHT 76978226 3137788 Live/Registered |
BROWN INNOVATION, LLC 2004-07-08 |
 SLEEPRIGHT 76601400 not registered Dead/Abandoned |
Power Products, Inc. 2004-07-08 |
 SLEEPRIGHT 75640170 not registered Dead/Abandoned |
Pacific Coast Feather Company 1999-02-10 |
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