Apnea Guard
Apnea Guard Device Kit Medium (10) Spanish (V2)
8manufacturers in China registered for this device type
32catalogue numbers in this listing
1510(k) clearance
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 | Advanced Brain Monitoring, Inc., United States |
|---|---|
| FDA product code | LRK |
| Device type | Device, Anti-Snoring |
| Device class | Class 2 |
| Regulation | 21 CFR 872.5570 |
| Establishment | Manufacturer |
| 510(k) | K111110 |
| Record published | 2016-09-23 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment humidity 15 to 95 % RH; Storage environment temperature -20 to 60 °C; Handling environment humidity 15 to 95 % RH; Handling environment temperature 5 to 40 °C |
| Packaging | Kit of 5 ag high of 5, kit of 5 ag low devi of 5, kit of 5 ag med of 5 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 25-1003 | In distribution | |
| AG25-1015(SPA) | In distribution | |
| AG25-1009 | In distribution | |
| 25-1001 | In distribution | |
| AG25-1009 | In distribution | |
| AG25-1003.10(SPA) | In distribution | |
| AG25-1009(SPA) | In distribution | |
| 25-5301 | In distribution | |
| AG25-5301.5 | In distribution | |
| AG25-1002.10 | In distribution | |
| AG25-1002.10(SPA) | In distribution | |
| AG25-1015 | In distribution | |
| 25-1002 | In distribution | |
| AG25-1004 | In distribution | |
| AG25-1012 | In distribution | |
| AG25-1015(SPA) | In distribution | |
| AG25-1015(UK) | In distribution | |
| AG25-1001.10(SPA) | In distribution | |
| AG25-1014 | In distribution | |
| AG25-1012 | In distribution | |
| AG25-1012(SPA) | In distribution | |
| 25-1003 | In distribution | |
| AG25-1009(UK) | In distribution | |
| AG25-1001.10 | In distribution | |
| AG25-1012(UK) | In distribution | |
| AG25-1013 | In distribution | |
| AG25-1011 | In distribution | |
| AG25-1009(SPA) | In distribution | |
| 25-1002 | In distribution | |
| 25-1001 | In distribution | |
| AG25-1012(SPA) | In distribution | |
| AG25-1003.10 | 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 |
| SML | Selane Products, 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K111110 | 2011-07-22 |
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.