Data / Medical devices / United States / Henry Schein One, LLC
Henry Schein One, LLC: FDA-registered device maker in Ames, IA, United States, 1 510(k) clearance
Henry Schein One, LLC is registered with the FDA (registration 3013464458) in Ames, IA, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 7, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013464458
- Address
- 2501 N Loop Dr Ste 1700, Ames, IA, United States, 50010
- Owner or operator
- Henry Schein One, LLC (10052982)
- Roles
- Manufacturer
- First device listed
- October 21, 2016
- Registered through
- 2026
- Brand names listed
- Dentrix Ascend Imaging, Dentrix Imaging Center, Dentrix Smart Image
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 7, 2015 | K151438 | Dentrix Ascend Imaging | LLZ | Substantially Equivalent | Realcloud Imaging, Inc. | accessdata.fda.gov |
Compare with other makers
Updated July 7, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.