Eurodent, Inc.
Country not established
- Devices
- 5
What Eurodent, Inc. makes
Eurodent, Inc. manufactures dental impression materials, including the ESSE QUATTRO and ESSE UNO for custom dental molds, as well as ISODENT for bite registration. The company also produces orthodontic accessories like BAR & RIDER, SCREWS, and TUBES for bracket placement, ISOLIGHT for dental isolation, and the STUDIO UNO for intraoral scanning.
These products are classified as Class I medical devices under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States.
Catalogue
Esse Quattro/Esse Uno Ref K894060
510(k) 510(k)Isodent Ref K894058
510(k) 510(k)Bar & Rider, Screws, Tubes Ref K790078
510(k) 510(k)Isolight Ref K894059
510(k) 510(k)Studio Uno Ref K894061
510(k) 510(k)
Frequently asked questions
How many devices does Eurodent, Inc. have in the registry?
The registry currently lists 5 devices for Eurodent, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Eurodent, Inc.'s devices?
Among its 5 most recently registered devices, Eurodent, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Eurodent, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Eurodent, Inc.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Eurodent, Inc. in the registry?
The most recently registered devices listed for Eurodent, Inc. include ESSE QUATTRO/ESSE UNO, ISODENT, BAR & RIDER, SCREWS, TUBES and ISOLIGHT.