Norian Corp.
United StatesFDA applicant, unverified
- Devices
- 3
What Norian Corp. makes
Norian Corp. manufactures bone cement formulations, including the Norian Periodontal/Dental Cement (PDC) for dental applications and the Norian Cranial Repair System (CRS) kits (5cc and 10cc) for cranial procedures. It also produces DENTORIDGE™ Hydroxylapatite, a dental material designed for specific oral and maxillofacial uses.
These products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearances. The company is based in the United States.
Catalogue
Norian Periodontal/Dental Cement (Pdc) Ref K983104
Regimes: 510(k) Registry: 510(k)Norian Cranial Repair System (Crs)Bone Cement- 5cc Kit, Norian Cranial Repair System (Crs) Bone Cement- 10cc Ref K973789
Regimes: 510(k) Registry: 510(k)Dentoridge(Tm) Hydroxyylapatite Ref K882098
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Norian Corp. have in the registry?
The registry currently lists 3 devices for Norian Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Norian Corp.'s devices?
Among its 3 most recently registered devices, Norian Corp. has devices listed in FDA 510(k) (3 devices).
What risk classes do Norian Corp.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Norian Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Norian Corp. in the registry?
The most recently registered devices listed for Norian Corp. include NORIAN PERIODONTAL/DENTAL CEMENT (PDC), NORIAN CRANIAL REPAIR SYSTEM (CRS)BONE CEMENT- 5CC KIT, NORIAN CRANIAL REPAIR SYSTEM (CRS) BONE CEMENT- 10CC and DENTORIDGE(TM) HYDROXYYLAPATITE.