EMA 3d
EMA 3D: 1 catalogue number listed by EMA-Sleep 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
1catalogue number
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 | EMA-Sleep Inc, United States |
|---|---|
| FDA product code | LQZ |
| Device type | Device, Jaw Repositioning |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5570 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K232735 |
| Record published | 2026-04-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LQZ | 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 |
| Slow Wave | Slow Wave, Inc. | 2 |
| Napa Appliance | Great Lakes Dental Technologies, Ltd. | 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 |
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.