Data / Medical devices / China / Changsha Honchon Technology Co., Ltd
Changsha Honchon Technology Co., Ltd: FDA-registered device maker in Changsha Hunan, China, 1 510(k) clearance
Changsha Honchon Technology Co., Ltd is registered with the FDA (registration 3018411778) in Changsha Hunan, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 8, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018411778
- Address
- Room 2316,2317,2319,2320, Building 1, Area 2 Jinqiao Market Cluster No. 1555 Purui Road,Huangjinyuan Street, Xiangjiang New District, Changsha Hunan, China, 410200
- Owner or operator
- Changsha Honchon Technology Co., LTD (10085686)
- Roles
- Manufacturer
- First device listed
- July 20, 2022
- Registered through
- 2026
- Brand names listed
- Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, Intraoral Scanner,HCE-IS-130,HCE-IS-300,HCE-IS-500,HCE-IS-800
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powder, Porcelain | EIH | 2 | Manufacturer | accessdata.fda.gov |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | 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 8, 2022 | K221051 | Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | EIH | Substantially Equivalent | Changsha Honchon Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Powder, Porcelain
- All makers of System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
Updated July 8, 2022. 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.