Hygedent, Inc.
ChinaFDA applicant, unverified FDA
- Devices
- 4
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Hygedent, Inc. makes
Hygedent, Inc. manufactures dental impression materials, including VPS (vinyl polysiloxane) and alginate options, designed for creating dental molds.
The company's products are regulated as Class II devices and are listed in the FDA's 510(k) registry. Hygedent is based in the United States.
Catalogue
VPS Impression Material Ref K191034
Regimes: 510(k) Registry: 510(k)VPS Impression Material Ref K203824
Regimes: 510(k) Registry: 510(k)Hygedent Alginate Impression Material Ref K140074
Regimes: 510(k) Registry: 510(k)HygePLUS Alginate Impression Material Ref K170812
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Hygedent Inc. Beijing · CN FEI 3011187729
Frequently asked questions
How many devices does Hygedent, Inc. have in the registry?
The registry currently lists 4 devices for Hygedent, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hygedent, Inc.'s devices?
Among its 4 most recently registered devices, Hygedent, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Hygedent, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Hygedent, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hygedent, Inc. in the registry?
The most recently registered devices listed for Hygedent, Inc. include VPS Impression Material, HYGEDENT ALGINATE IMPRESSION MATERIAL and HygePLUS Alginate Impression Material.
Which FDA establishments are linked to Hygedent, Inc.?
1 FDA establishment is linked to Hygedent, Inc. in the registry; they are listed on the company page.