SML
Ucla MOD. Herbst-ONE Segment U OR L
4manufacturers in China registered for this device type
27catalogue numbers in this listing
2510(k) clearances naming this product code
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 | Selane Products, Inc., United States |
|---|---|
| FDA product code | LQZ |
| Device type | Device, Jaw Repositioning |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5570 |
| 510(k) | K052862 |
| Record published | 2017-08-04 |
| Record revised | 2021-10-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 63250TS | In distribution | |
| 63760TS | In distribution | |
| 63226S | In distribution | |
| 63224S | In distribution | |
| 63250AHS | In distribution | |
| 63750S | In distribution | |
| 63250S | In distribution | |
| 66030S | In distribution | |
| 63225AHS | In distribution | |
| 63760VHS | In distribution | |
| 63251S | In distribution | |
| 63760S | In distribution | |
| 63260S | In distribution | |
| 63250PS | In distribution | |
| 63225AS | In distribution | |
| 63250AS | In distribution | |
| 63760HLS | In distribution | |
| 60994S | In distribution | |
| 63725S | In distribution | |
| 63760KS | In distribution | |
| 63725AS | In distribution | |
| 63760TES | In distribution | |
| 63725-PMTS | In distribution | |
| 63250SLS | In distribution | |
| 63252S | In distribution | |
| 63760AS | In distribution | |
| 60994LS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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 |
|---|---|
| K162816 | 2017-07-27 |
| K130130 | 2013-08-26 |
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.