Healex Products, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Healex Products, Inc. makes
Healex Products, Inc. manufactures dental materials, including temporary dental cements formulated with potassium nitrate and zinc oxide eugenol, as well as a subliminator device for dental applications.
The company’s portfolio is regulated under FDA’s Class II device classification, with products authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Subliminator Ref K961457
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Healex Products, Inc. have in the registry?
The registry currently lists 3 devices for Healex Products, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Healex Products, Inc.'s devices?
Among its 3 most recently registered devices, Healex Products, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Healex Products, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Healex Products, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Healex Products, Inc. in the registry?
The most recently registered devices listed for Healex Products, Inc. include POTASSIUM NITRATE/ZINC OXIDE EUGENOL TEMPORARY DENTAL CEMENT, SUBLIMINATOR and POTASSIUM NITRATE ZINC OXIDE EUGENOL TEMP CEMENT (MODIFICATION).