Henry Schein One, LLC
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000038317 FEI 3013464458
- Devices
- 5
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
- Authorised rep.
- Advena LimitedMT
What Henry Schein One, LLC makes
Henry Schein One, LLC manufactures intraoral dental imaging systems, including the Dentally Vision platform, which captures high-resolution digital scans of oral structures for diagnostic and treatment planning purposes. These devices are designed to replace traditional film-based imaging, providing real-time imaging capabilities for dental professionals. The systems are intended for use in general dental practices and specialty clinics.
The company’s intraoral imaging systems fall under Class I regulatory classification, indicating minimal risk. These devices are listed in the EUDAMED database, though their regulatory status is determined by the relevant national authorities where they are marketed. The manufacturer is based in the United States.
Catalogue
- Regimes: CE MDD Registry: EUDAMED
- Registry: GUDID
- Registry: GUDID
- Registry: GUDID
- Regimes: CE MDD Registry: EUDAMED
Company details
- EUDAMED SRN
- US-MF-000038317
- FDA FEI number
- 3013464458
- DUNS number
- 116839885
- EUDAMED status
- Active
- EUDAMED registered name
- Henry Schein One, LLC
- EUDAMED abbreviated name
- HS1
- Registered address
- 2501, N Loop Dr Suite 1700, 50010, Ames, Iowa, United States
- [email protected]
- Phone
- 5155127956
- PRRC contact
- Brian Olesen
Frequently asked questions
How many devices does Henry Schein One, LLC have in the registry?
The registry currently lists 5 devices for Henry Schein One, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Henry Schein One, LLC's devices?
Among its 5 most recently registered devices, Henry Schein One, LLC has devices listed in EUDAMED (2 devices) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Henry Schein One, LLC's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Henry Schein One, LLC's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Henry Schein One, LLC in the registry?
The most recently registered devices listed for Henry Schein One, LLC include Dentally Vision, Dentrix Smart Image 1, Dentrix Ascend Imaging 1 and RealCloud HD1.