The Slide
by Biotex, Inc.
510(k) K203712
The Slide is a medical device (FDA Class II; FDA product code LQZ, Device, Jaw Repositioning) made by Biotex, Inc., cleared under FDA 510(k) K203712 on 20 Jul 2021, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK203712 | Date20 Jul 2021 | StatusActive |
Official records
- FDA 510(k) database K203712
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LQZ
- Device class
- Class II
- Regulation
- 21 CFR Part 872.5570
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K203712
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| The Slide® 046-1000 | 046-1000 | M71004610000 | — | On the market |
| The Slide® 046-1500 | 046-1500 | M71004615000 | — | On the market |
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