Data / Medical devices / United States / Hiossen, Inc.
Hiossen, Inc.: FDA-registered device maker in Buena Park, CA, United States, 2 510(k) clearances
Hiossen, Inc. is registered with the FDA (registration 3031162123) in Buena Park, CA, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated May 29, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3031162123
- Address
- 6940 Beach Blvd Building D Unit D-709, Buena Park, CA, United States, 90621
- Owner or operator
- Hiossen Inc. (10026425)
- Roles
- Manufacturer
- First device listed
- August 6, 2013
- Registered through
- 2026
- Brand names listed
- EK Digital Abutments, ET SMARTFit Abutment
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 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 |
|---|---|---|---|---|---|---|
| May 29, 2024 | K233389 | EK Digital Abutments | NHA | Substantially Equivalent | Hiossen, Inc. | accessdata.fda.gov |
| June 28, 2013 | K123627 | ET SMARTFIT ABUTMENT | NHA | Substantially Equivalent | Hiossen, Inc. | accessdata.fda.gov |
Compare with other makers
Updated May 29, 2024. 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.