Hdi, Inc.
South KoreaFDA applicant, unverified
- Devices
- 2
What Hdi, Inc. makes
HDI, Inc. manufactures dental composite resins and related materials, including DENU Composite Resin, DENU Flow Resin, and various body and putty sets designed for dental restorations. These products are formulated in light, heavy, and putty consistencies, with regular and fast-cure options.
The company’s portfolio is classified under FDA Class II devices and is listed via 510(k) clearance in the United States. HDI, Inc. is based in the US.
Catalogue
DENU Composite Resin, DENU Flow Resin Ref K213339
Regimes: 510(k) Registry: 510(k)DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) Ref K222741
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hdi, Inc. have in the registry?
The registry currently lists 2 devices for Hdi, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hdi, Inc.'s devices?
Among its 2 most recently registered devices, Hdi, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Hdi, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Hdi, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hdi, Inc. in the registry?
The most recently registered devices listed for Hdi, Inc. include DENU Composite Resin, DENU Flow Resin and DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast).