Manufacturer registered with FDA
Xiamen Yizhou Imp. & Exp. Co., Ltd.
Xiamen, China. Lists 6 dental device types with FDA across 1 registered establishment.
- Device types listed
- 6
- Brands and models
- 33
- 510(k) clearances
- 0as applicant
- Markets registered in
- 32 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name Xiamen Yizhou Imp. & Exp. Co., Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Xiamen Yizhou Imp. & Exp. Co., Ltd. | 6 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Xiamen Yizhou Imp. & Exp. Co., Ltd. | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Xiamen Yizhou Imp. & Exp. Co.,Ltd. | 1 | 2017–2017 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Xiamen Yizhou Imp. & Exp. Co., Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Anti-Snoring DeviceLRK · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | Bright Guard Pro 2Dormiva Anti-Snoring Mouth GuardEliminator Pro 2Intelliguard ProSerenity Pro 2SilentZPro 2Somnos Anti-Snoring Mouth GuardSomnos Pro 2TranquilityTranquility Anti-Snoring Mouth Guard 4 moreTranquility PROTranquility Pro 2Tranquility PRO 2 Anti-Snoring Mouth GuardTranquility PRO Anti-Snoring Mouth Guard | 2021 |
| Jaw Repositioning DeviceLQZ · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | Bright Guard Pro 2Dormiva Anti-Snoring Mouth GuardEliminator Pro 2Intelliguard ProSerenity Pro 2Somnos Anti-Snoring Mouth GuardSomnos Pro 2TranquilityTranquility Anti-Snoring Mouth GuardTranquility PRO 3 moreTranquility Pro 2Tranquility PRO 2 Anti-Snoring Mouth GuardTranquility PRO Anti-Snoring Mouth Guard | 2021 |
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Maker | teeth whitening LED light;teeth whitening light; teeth whitening mouth tray LED light;teeth whitening accelerator | 2018 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Anti Snore Mouth TrayImpression Mouth Tray(For grinding,TeethWhitening)Mouthguard | 2016 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Cheek Retractor | 2016 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | plastic case | 2023 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Xiamen Yizhou Imp. & Exp. Co., Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Koncept Innovators, LLC (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 23 Nov 2020 | K201484 | Somnos Anti-Snoring Mouth Guard | Koncept Innovators, LLC | LRK Anti-Snoring Device |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| XIAMEN YIZHOU IMP. & EXP. CO., LTD.FDA reg. 3008763803 | Xiamen Fujian, China | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10053196). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.