Dentium USA
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000024259 FEI 3005503242
Dentium USA is a medical device manufacturer based in the United States, with 182 devices listed in FDA GUDID and EUDAMED (FDA Class II) and 1 FDA recall as of 12 Nov 2026.
- Devices
- 182
- Registrations
- EUDAMEDFDA
- FDA recalls
- 1
Registry facts
- Registries
- FDA GUDID 182
- EUDAMED 60
- Device classes
- FDA Class II 182
- FDA recalls
- Identifiers
- EUDAMED SRN US-MF-000024259
- FDA FEI 3005503242
- DUNS 079689366
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
Catalogue
Search and filter all 182 devicesShowing 1-50 of 182
Company details
- EUDAMED SRN
- US-MF-000024259
- FDA FEI number
- 3005503242
- DUNS number
- 079689366
- EUDAMED status
- Active
- EUDAMED registered name
- Dentium USA
- Registered address
- 6761, Katella Avenue, 90630, Cypress, United States
- Website
- www.dentiumusa.com
- info@dentiumusa.com
- Phone
- +7142260229
- PRRC contact
- Eun Kyung Son
FDA recalls
2007
- 29 Jun 2007 Z-1119-2007 Unclassified (pre-2012) Terminated Lack of validation for sterilization cycle: This recall was initiated because the validation of the sterilization process for these devices has not been completed. As a result, Biomedicare cannot assure the sterility of fixtures distributed to date.
Frequently asked questions
How many devices does DENTIUM USA have in the registry?
The registry currently lists 182 devices for DENTIUM USA. Devices recorded under merged duplicate company entries are counted once.
Which registries list DENTIUM USA's devices?
Among its 50 most recently registered devices, DENTIUM USA has devices listed in EUDAMED (15 devices) and FDA GUDID (50 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do DENTIUM USA's devices fall under?
Among its 50 most recently registered devices, the classes recorded for DENTIUM USA's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for DENTIUM USA?
FDA recall records list 1 recall initiated by DENTIUM USA, the most recent initiated on 29 Jun 2007. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from DENTIUM USA in the registry?
The most recently registered devices listed for DENTIUM USA include SuperLine II FXS7007C, Dual Abutment DAB5545NL, SuperLine II FXS5012C and Dual Abutment DAB4535HL.