Tokuyama America, Inc.
United StatesFDA applicant, unverified
- Devices
- 22
What Tokuyama America, Inc. makes
Tokuyama America, Inc. manufactures dental materials for restorative and prosthetic applications, including light-cured resin liners (e.g., PALFIQUE LIGHT LINER), bonding agents (e.g., TOKUSO LIGHT BOND), and relining compounds (e.g., TOKUYAMA SOFT RELINING). Their portfolio also includes composite inlays (PALFIQUE INLAY), posterior restorative resins (PALFIQUE LITEPOSTERIOR), and adhesive systems (TOKUYAMA M-BOND). These products are designed for dental laboratories and practitioners to fabricate and repair dentures, crowns, and fillings.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. Their products are intended for use in the United States, where they comply with applicable dental device standards. The portfolio is not registered in other major regulatory databases.
Catalogue
Search and filter all 22 devicesFrequently asked questions
How many devices does Tokuyama America, Inc. have in the registry?
The registry currently lists 22 devices for Tokuyama America, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Tokuyama America, Inc.'s devices?
Among its 22 most recently registered devices, Tokuyama America, Inc. has devices listed in FDA 510(k) (22 devices).
What risk classes do Tokuyama America, Inc.'s devices fall under?
Among its 22 most recently registered devices, the classes recorded for Tokuyama America, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Tokuyama America, Inc. in the registry?
The most recently registered devices listed for Tokuyama America, Inc. include PALFIQUE LIGHT LINER, BISTITE II SC, PALFIQUE ESTELITE and TOKUSO LIGHT BOND.