SML
Full BREATH--W/02 Tubes AND Ball Clasps
8manufacturers in China registered for this device type
32catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (6), Zhejiang (1), Fujian (1). 3 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 |
| Dongguan Yiyao Science & Technology Development Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 2 |
| Dongyang City Yonoel Outdoor Products Co., Ltd. | Dongyang | Zhejiang | Contract manufacturer | 32 |
| Digital Dental Depot | Zhuhai | Guangdong | Contract manufacturer | 17 |
| Shenzhen Sany Pioneer Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 9 |
| Zhuhai DS Dental Technology Co., Ltd. | Zhuhai | Guangdong | Manufacturer | 8 |
| Shenzhen Kesite Digital Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 4 |
Record
| Listed by | Selane Products, Inc., United States |
|---|---|
| FDA product code | LRK |
| Device type | Device, Anti-Snoring |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5570 |
| 510(k) | K083209 |
| 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 |
|---|---|---|
| 63220S | In distribution | |
| 63603AACS | In distribution | |
| 63316EAS | In distribution | |
| 63603WS | In distribution | |
| 63603ACO2S | In distribution | |
| 63603NS | In distribution | |
| 63280S | In distribution | |
| 63316GS | In distribution | |
| 63603AAS | In distribution | |
| 63320S | In distribution | |
| 63300S | In distribution | |
| 63221S | In distribution | |
| 63312S | In distribution | |
| 63603L | In distribution | |
| 63400S | In distribution | |
| 63120S | In distribution | |
| 63603AS | In distribution | |
| 63210S | In distribution | |
| 63316ES | In distribution | |
| 63603AO2S | In distribution | |
| 63310S | In distribution | |
| 63316S | In distribution | |
| 63603PMTS | In distribution | |
| 63280AS | In distribution | |
| 63316AS | In distribution | |
| 63603LS | In distribution | |
| 63400TS | In distribution | |
| 63603ALCS | In distribution | |
| 63120BS | In distribution | |
| 63270S | In distribution | |
| 63313S | In distribution | |
| 63603AAO2S | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Emerald Herbst | Island Dental LAB DBA Emerald Dental LAB | 141 |
| EMA | The Myerson Company Limited | 94 |
| Apnea Guard | Advanced Brain Monitoring, Inc. | 32 |
| SomnoDent Avant | Somnomed, Ltd. | 11 |
| Itus Mouthguardz | Shinrin-Yoku Traders LLC | 8 |
| Virtus | Somnomed, Ltd. | 7 |
| Silent Nite Sleep Appliance with Glidewell Hinge | Prismatik Dentalcraft, Inc. | 7 |
| ZQuiet S.A. | Sleeping Well, LLC | 6 |
| Zyppah | A.M.A. Plastics | 6 |
| AIRvance™ | Medtronic Xomed, Inc. | 5 |
| Anti-snoring, restoration | Modern Dental Laboratory (DG) Co., Ltd. | 4 |
| EMA Custom | The Myerson Company Limited | 4 |
Showing 12 of 209. All products under Device, Anti-Snoring
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.