Slow Wave
Slow Wave: 2 catalogue numbers listed by Slow Wave, Inc., United States, under Device, Jaw Repositioning. 4 manufacturers in China are registered for this product code.
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 | Slow Wave, 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) | K191320 |
| Record published | 2023-05-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AT | In distribution | |
| DS8 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SML | Selane Products, Inc. | 27 |
| Narval CC | Resmed Motor Technologies Inc. | 3 |
| The Slide® | Biotex, 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 |
|---|---|
| K191320 | 2020-10-02 |
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.