Data / Medical devices / China / Hygedent Inc.
Hygedent Inc.: FDA-registered device maker in Beijing, China, 4 510(k) clearances
Hygedent Inc. is registered with the FDA (registration 3011187729) in Beijing, China. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated April 19, 2021. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3011187729
- Address
- Gate E, Building 1, No.97 Changping Road Shahe Town, Changping District, Beijing, China, 102206
- Owner or operator
- HYGEDENT INC. (10047045)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- June 17, 2014
- Registered through
- 2026
- Brand names listed
- CHROMATIC, HYGECHROMA, HYGEDENT, HYGEMAX, HYGEPLUS, HygePLUS Alginate Impression Material, VPS Impression Material
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Material, Impression | ELW | 2 | Contract manufacturer, Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| April 19, 2021 | K203824 | VPS Impression Material | ELW | Substantially Equivalent | Hygedent, Inc. | accessdata.fda.gov |
| September 4, 2019 | K191034 | VPS Impression Material | ELW | Substantially Equivalent | Hygedent, Inc. | accessdata.fda.gov |
| July 26, 2017 | K170812 | HygePLUS Alginate Impression Material | ELW | Substantially Equivalent | Hygedent, Inc. | accessdata.fda.gov |
| May 21, 2014 | K140074 | HYGEDENT ALGINATE IMPRESSION MATERIAL | ELW | Substantially Equivalent | Hygedent, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 19, 2021. 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.