Denken-Highdental Co., Ltd.
JapanFDA applicant, unverified FDA FEI 3010564008
- Devices
- 28
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Denken-Highdental Co., Ltd. makes
Denken-Highdental Co., Ltd. produces dental appliance fabrication materials, specifically zirconia-based discs used in dental restorations and prosthetics. These discs are designed for milling or grinding in the fabrication of ceramic dental crowns, bridges, and other fixed restorations.
The company’s zirconia discs are classified as Class II medical devices in the US and are listed under the FDA’s 510(k) and UDI (Unique Device Identification) registries. The manufacturer is based in the United States.
Catalogue
Search and filter all 28 devicesCompany details
- FDA FEI number
- 3010564008
- DUNS number
- 693815540
- Address
- 24-3 Kisshoin Ishiharakyomichi-Cho, Kyoto
Frequently asked questions
How many devices does Denken-Highdental Co., Ltd. have in the registry?
The registry currently lists 28 devices for Denken-Highdental Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Denken-Highdental Co., Ltd.'s devices?
Among its 28 most recently registered devices, Denken-Highdental Co., Ltd. has devices listed in FDA 510(k) (1 device) and FDA GUDID (27 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Denken-Highdental Co., Ltd.'s devices fall under?
Among its 28 most recently registered devices, the classes recorded for Denken-Highdental Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Denken-Highdental Co., Ltd. in the registry?
The most recently registered devices listed for Denken-Highdental Co., Ltd. include KDF Zirconia Disc MU-A1/16mm, KDF Zirconia Disc MU-A1/35mm, KDF Zirconia Disc MU-BL2/25mm and KDF Zirconia Disc MU-A2/10mm.