Heraeus Kulzer, LLC (Mitsui Chemicals Group)
United StatesFDA applicant, unverified
- Devices
- 2
What Heraeus Kulzer, LLC (Mitsui Chemicals Group) makes
Heraeus Kulzer, LLC manufactures dental restorative materials, including composite resin systems like Charisma for tooth restoration, and bonding agents such as iBond Universal and iBond Ceramic Primer for adhesion in dental procedures.
These products are classified as Class II medical devices under FDA regulations and are listed via the 510(k) clearance process. The company operates within the United States.
Catalogue
Charisma Ref K160049
Regimes: 510(k) Registry: 510(k)iBond Universal & iBond Ceramic Primer Ref K150933
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Heraeus Kulzer, LLC (Mitsui Chemicals Group) have in the registry?
The registry currently lists 2 devices for Heraeus Kulzer, LLC (Mitsui Chemicals Group). Devices recorded under merged duplicate company entries are counted once.
Which registries list Heraeus Kulzer, LLC (Mitsui Chemicals Group)'s devices?
Among its 2 most recently registered devices, Heraeus Kulzer, LLC (Mitsui Chemicals Group) has devices listed in FDA 510(k) (2 devices).
What risk classes do Heraeus Kulzer, LLC (Mitsui Chemicals Group)'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Heraeus Kulzer, LLC (Mitsui Chemicals Group)'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Heraeus Kulzer, LLC (Mitsui Chemicals Group) in the registry?
The most recently registered devices listed for Heraeus Kulzer, LLC (Mitsui Chemicals Group) include Charisma and iBond Universal & iBond Ceramic Primer.