Manufacturer registered with FDA
Huliang (shanghai) Bio-Tech Co., Ltd.
Shanghai, China. Lists 3 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 3
- Brands and models
- 5
- 510(k) clearances
- 12023–2023
- Markets registered in
- 55 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 5 markets
Where regulators' registries name Huliang (shanghai) Bio-Tech 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 | Huliang (shanghai) Bio-Tech Co., Ltd. | 1 clearances | 2023–2023 | Below |
| Israel | AMAR | Manufacturer | Huliang (Shanghai) Bio-Tech Co., Ltd.Huliang (Shanghai) Bio-Tech Co.Ltd | 2 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Huliang (Shanghai) Bio-Tech Co Ltd | 1 | 2023–2023 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Huliang(Shanghai)Bio-Tech Co., Ltd. | 1 | — | Pure Global AI |
| Japan | PMDA | Registration holder | Ｈｕｌｉａｎｇ （Ｓｈａｎｇｈａｉ） Ｂｉｏ－Ｔｅｃｈ Ｃｏ．， Ｌｔｄ | 1 | 2026–2026 | 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 Huliang (shanghai) Bio-Tech 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 |
|---|---|---|---|---|
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | Perfect PMMAPMMA BLOCK | 2023 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | Perfect PMMAPMMA BLOCK | 2023 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | Wax Disc | 2022 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Huliang (shanghai) Bio-Tech Co., Ltd.FDA reg. 3020093493 | Shanghai, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10086927). 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.