Exacta Dental Direct, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 2
What Exacta Dental Direct, Inc. makes
Exacta Dental Direct, Inc. manufactures dental materials for temporary crown and bridge restorations, including the FIXTEMP C&B system and Fixtemp Cement. These products are designed for chairside fabrication and cementation of provisional restorations in dental practice settings.
The company’s portfolio is regulated under FDA Class II devices and requires 510(k) clearance. The products are listed in the FDA’s 510(k) database. The manufacturer is based in the United States.
Catalogue
Fixtemp C&B Ref K102917
510(k) 510(k)Fixtemp Cement Ref K142446
510(k) 510(k)
Frequently asked questions
How many devices does Exacta Dental Direct, Inc. have in the registry?
The registry currently lists 2 devices for Exacta Dental Direct, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Exacta Dental Direct, Inc.'s devices?
Among its 2 most recently registered devices, Exacta Dental Direct, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Exacta Dental Direct, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Exacta Dental Direct, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Exacta Dental Direct, Inc. in the registry?
The most recently registered devices listed for Exacta Dental Direct, Inc. include FIXTEMP C&B and Fixtemp Cement.