Manufacturer registered with FDA
Shenzhen Sany Pioneer Technology Co.,Ltd
Shenzhen, China. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 20
- 510(k) clearances
- 0as applicant
- Markets registered in
- 444 registrations outside the US
- Establishments
- 1China
Registered in 4 markets
Where regulators' registries name Shenzhen Sany Pioneer Technology 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 | Shenzhen Sany Pioneer Technology Co.,Ltd | 2 device types | — | Below |
| Canada | Health Canada | Registration holder | SHENZHEN SANY PIONEER TECHNOLOGY CO., LTD. | 40 | 2025–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | SHENZHEN SANY PIONEER TECHNOLOGY CO., LTD.SHENZHEN SANY PIONEERTECHNOLOGY CO., LTD | 3 | 2025–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Shenzhen Sany Pioneer Technology Co Ltd | 1 | 2025–2025 | 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 Shenzhen Sany Pioneer Technology 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 | Everness Anti Snoring Mouthpiece L07Innoflow Anti Snoring Mouthpiece L07Innoflow Anti Snoring Mouthpiece L08Innoflow Anti Snoring Mouthpiece L09Joybloom Anti Snoring Mouthpiece L08Joybloom Anti Snoring Mouthpiece L09Masktouch Anti Snoring Mouthpiece L07Wedoheal Anti Snoring Mouthpiece L07Wedoheal Anti Snoring Mouthpiece L08Willnice Anti Snoring Mouthpiece L07 2 moreWillnice Anti Snoring Mouthpiece L08Willnice Anti Snoring Mouthpiece L09 | 2025 |
| Jaw Repositioning DeviceLQZ · Class 2 | Anti-snoring & jaw-repositioning devices | Maker | Everness Anti Snoring Mouthpiece L07Innoflow Anti Snoring Mouthpiece L07Innoflow Anti Snoring Mouthpiece L09Joybloom Anti Snoring Mouthpiece L09Masktouch Anti Snoring Mouthpiece L07Wedoheal Anti Snoring Mouthpiece L07Willnice Anti Snoring Mouthpiece L07Willnice Anti Snoring Mouthpiece L09 | 2025 |
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
Shenzhen Sany Pioneer Technology 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: Ram.Shaw Pte., Ltd. (2), Dcstar, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 27 Aug 2026 | K262104 | Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT) | Ram.Shaw Pte., Ltd. | LRK Anti-Snoring Device |
| 3 Mar 2026 | K253845 | Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) | Ram.Shaw Pte., Ltd. | LRK Anti-Snoring Device |
| 22 Oct 2025 | K251628 | Mandibular Advancement Device L07 | Dcstar, Inc. | LRK Anti-Snoring Device |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SHENZHEN SANY PIONEER TECHNOLOGY CO., LTD.FDA reg. 3016674860 | Shenzhen Guangdong, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10062741). 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.