Data / Medical devices / China / Huliang (shanghai) Bio-Tech Co., Ltd.
Huliang (shanghai) Bio-Tech Co., Ltd.: FDA-registered device maker in Shanghai, China, 1 510(k) clearance
Huliang (shanghai) Bio-Tech Co., Ltd. is registered with the FDA (registration 3020093493) in Shanghai, China. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 12, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3020093493
- Address
- Bldg 23, No. 1058 Zhengxu Rd, Lingang New Area, Shanghai Pilot Free Trade Zone, Shanghai, 201400, P.R. China, Shanghai, China, 201400
- Owner or operator
- Huliang (shanghai) Bio-Tech Co., Ltd. (10086927)
- Roles
- Manufacturer
- First device listed
- December 22, 2022
- Registered through
- 2026
- Brand names listed
- PMMA BLOCK, Perfect PMMA, Wax Disc
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Crown And Bridge, Temporary, Resin | EBG | 2 | Manufacturer | accessdata.fda.gov |
| Mouthguard, Prescription | MQC | U | Manufacturer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Manufacturer | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 12, 2023 | K223706 | PMMA BLOCK | EBG | Substantially Equivalent | Huliang(Shanghai) Bio-Tech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Crown And Bridge, Temporary, Resin
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Mouthguard, Prescription
- All makers of Wax, Dental, Intraoral
Updated May 12, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.