The Slide®
Slide Acrylic.
4manufacturers in China registered for this device type
2catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (3), Fujian (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Modern Dental Laboratory (DG) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 15 |
| Xiamen Yizhou IMP. & EXP. Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 10 |
| Digital Dental Depot | Zhuhai | Guangdong | Contract manufacturer | 17 |
| Shenzhen Sany Pioneer Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
Record
| Listed by | Biotex, Inc., United States |
|---|---|
| FDA product code | LQZ |
| Device type | Device, Jaw Repositioning |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5570 |
| Establishment | Manufacturer |
| 510(k) | K203712 |
| Record published | 2023-05-19 |
| Record revised | 2023-05-08 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Storage | Handling environment temperature up to 45 °C; Storage environment temperature up to 45 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 046-1500 | In distribution | |
| 046-1000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SML | Selane Products, Inc. | 27 |
| Narval CC | Resmed Motor Technologies Inc. | 3 |
| Slow Wave | Slow Wave, Inc. | 2 |
| Napa Appliance | Great Lakes Dental Technologies, Ltd. | 1 |
| EMA 3D | EMA-Sleep Inc | 1 |
| Kava Dorsal Dual Laminate | Apex Dental Sleep LAB | 1 |
| Kava Herbst Acrylic | Apex Dental Sleep LAB | 1 |
| Napa (Nocturnal Airway Patency Appliance) | John’s Dental Laboratory Inc | 1 |
| Narval CC | Resmed PTY Ltd. | 1 |
| Kava Dorsal Acrylic | Apex Dental Sleep LAB | 1 |
| Kava Herbst Dual Laminate | Apex Dental Sleep LAB | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K203712 | 2021-07-20 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.