Data / Medical devices / China / Deprag High Tech Materials ( Zhengzhou ) Co.,ltd.
Deprag High Tech Materials ( Zhengzhou ) Co.,ltd.: FDA-registered device maker in ZHANGZHOU Henan, China, 2 510(k) clearances
Deprag High Tech Materials ( Zhengzhou ) Co.,ltd. is registered with the FDA (registration 3034729565) in ZHANGZHOU Henan, China. It lists 6 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 3, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3034729565
- Address
- No.101,1st Floor,Building 12,No.8 Jinzhan Street,High-tech Industrial Development Zone, ZHANGZHOU Henan, China, 450066
- Owner or operator
- DEPRAG High tech Materials ( Zhengzhou ) Co.,Ltd. (10092180)
- Roles
- Manufacturer
- First device listed
- December 12, 2024
- Registered through
- 2026
- Brand names listed
- Dental Lithium Disilicate Glass-Ceramic, Dental Model Materials, Dental Zirconia Ceramic, Diamond burs, Firing paste, Light Cure Composite Resin, NiTi-File, Synthetic resin teeth
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Alloy, Other Noble Metal | EJS | 2 | Manufacturer | accessdata.fda.gov |
| Denture, Plastic, Teeth | ELM | 2 | Manufacturer | accessdata.fda.gov |
| File, Pulp Canal, Endodontic | EKS | 1 | Manufacturer | accessdata.fda.gov |
| Instrument, Diamond, Dental | DZP | 1 | Manufacturer | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Manufacturer | accessdata.fda.gov |
| Powder, Porcelain | EIH | 2 | 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 |
|---|---|---|---|---|---|---|
| July 3, 2023 | K230487 | Dental Lithium Disilicate Glass-Ceramic | EIH | Substantially Equivalent | Fuzhou Rick Brown Biomaterials Co., Ltd. | accessdata.fda.gov |
| November 12, 2021 | K212259 | Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | EIH | Substantially Equivalent | Zirdent New Material Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of File, Pulp Canal, Endodontic
- All makers of Alloy, Other Noble Metal
- All makers of Denture, Plastic, Teeth
- All makers of Material, Impression Tray, Resin
- All makers of Instrument, Diamond, Dental
- All makers of Powder, Porcelain
Updated July 3, 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.