The Slide™
GUDID M71004610000
BIOTEX, INC.
Mandible-repositioning sleep-disordered breathing orthosis| Primary Device ID | M71004610000 |
| NIH Device Record Key | 81a51c63-29cb-4763-af6d-6c9ad677bf66 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | The Slide™ |
| Version Model Number | 046-1000 |
| Company DUNS | 969792050 |
| Company Name | BIOTEX, 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 | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx | |
| Phone | 7137410111 |
| xx@xx.xx |
Operating and Storage Conditions
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Handling Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
| Storage Environment Temperature | Between 0 Degrees Celsius and 45 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | M71004610000 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K203712
FDA Product Code
| LQZ | Device, Jaw Repositioning |
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 | 2021-09-09 |
| Device Publish Date | 2021-09-01 |
Devices Manufactured by BIOTEX, INC.
| M71004614002 - Slide Bite Fork | 2025-03-10 |
| M710WW1D0 - Wire Watch™ | 2024-07-11 |
| M710TCW101200 - Bayou™ troCarWash System Disposable Kit | 2024-02-08 |
| M71003810000 - Bayou™ troCarWash System Disposable Kit | 2023-08-14 |
| M71003850000 - Bayou™ troCarWash System Controller | 2023-08-14 |
| M71004615000 - The Slide® | 2023-05-29 Slide Nylon. |
| M71002110010 - Wire Watch™ | 2023-02-17 |
| M710ERGUIDE10102 - OcciGuide | 2022-06-17 |
Trademark Results [The Slide]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 THE SLIDE 87868243 not registered Live/Pending |
LeBlanc Dental Products, Inc. 2018-04-09 |
 THE SLIDE 78280158 2921725 Dead/Cancelled |
Mancinelli, Ricci 2003-07-29 |
 THE SLIDE 78128460 not registered Dead/Abandoned |
international bullion and metal brokers(usa) inc 2002-05-14 |
 THE SLIDE 74371263 not registered Dead/Abandoned |
Fitness Innovations, Inc. 1993-03-24 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.