Kyocera International, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 3
What Kyocera International, Inc. makes
Kyocera International, Inc. manufactures dental implants, including porous ceramic and high-purity aluminum-based implants, as well as a dental material called Cerapearl. These products are designed for use in oral and maxillofacial reconstruction.
The company’s portfolio is regulated under FDA Class II devices, with products authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Kyocera Bioceram Porous Dental Implant Ref K860360
510(k) 510(k)Dental Material, Implant, High-Purity Al Ref K760008
510(k) 510(k)Cerapearl Ref K854763
510(k) 510(k)
Frequently asked questions
How many devices does Kyocera International, Inc. have in the registry?
The registry currently lists 3 devices for Kyocera International, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Kyocera International, Inc.'s devices?
Among its 3 most recently registered devices, Kyocera International, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Kyocera International, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Kyocera International, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Kyocera International, Inc. in the registry?
The most recently registered devices listed for Kyocera International, Inc. include KYOCERA BIOCERAM POROUS DENTAL IMPLANT, DENTAL MATERIAL, IMPLANT, HIGH-PURITY AL and CERAPEARL.