Data / Medical devices / United States / Osseofuse International Inc.
Osseofuse International Inc.: FDA-registered device maker in Las Vegas, NV, United States, 5 510(k) clearances
Osseofuse International Inc. is registered with the FDA (registration 3008494722) in Las Vegas, NV, United States. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated October 10, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3008494722
- Address
- 6170 West Desert Inn Rd. Suite B, Las Vegas, NV, United States, 89146
- Owner or operator
- Osseofuse International Inc. (10033351)
- Roles
- Specification developer
- First device listed
- November 18, 2011
- Registered through
- 2026
- Brand names listed
- HexaPLUS S, HexaPLUS S OneDrill Implant System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Specification developer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| October 10, 2025 | K243078 | HexaPLUS S OneDrill Implant System | DZE | Substantially Equivalent | Osseofuse International, Inc. | accessdata.fda.gov |
| May 24, 2019 | K181157 | Conical Plus Implant System | DZE | Substantially Equivalent | Osseofuse International, Inc. | accessdata.fda.gov |
| September 19, 2014 | K133050 | ONE PLUS IMPLANT SYSTEM | DZE | Substantially Equivalent | Osseofuse, Inc. | accessdata.fda.gov |
| October 31, 2013 | K131748 | OSSEOFUSE DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Osseofuse, Inc. | accessdata.fda.gov |
| July 14, 2011 | K110577 | OSSEOFUSE DENTAL IMPLANT SYSTEM | DZE | Substantially Equivalent | Dynamic Innovations, Inc. | accessdata.fda.gov |
Compare with other makers
Updated October 10, 2025. 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.