Dentsoll, Inc.
Country not established
- Devices
- 1
What Dentsoll, Inc. makes
Dentsoll, Inc. manufactures dental acrylic resins, including ACRYTONE, REZEN NF, and ISO FAST, which are used for fabricating custom dentures and dental prosthetics. These materials are designed for dental laboratory use to create durable, patient-specific dental restorations.
The company’s products are classified as Class II medical devices under FDA regulations and are authorised through the 510(k) clearance process. These devices are listed in the FDA’s 510(k) database, adhering to U.S. regulatory standards for dental materials.
Catalogue
Acrytone, Rezen Nf, And Iso Fast Denture Resins Ref K130680
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Dentsoll, Inc. have in the registry?
The registry currently lists 1 device for Dentsoll, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dentsoll, Inc.'s devices?
Among its 1 most recently registered device, Dentsoll, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Dentsoll, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Dentsoll, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Dentsoll, Inc. in the registry?
The most recently registered devices listed for Dentsoll, Inc. include ACRYTONE, REZEN NF, AND ISO FAST DENTURE RESINS.