Manufacturer registered with FDA
Osseofuse International Inc.
Las Vegas, NV, United States. Lists 2 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 2
- Brands and models
- 4
- 510(k) clearances
- 22019–2025
- Markets registered in
- 24 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name Osseofuse International Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Osseofuse International Inc. | 2 clearances | 2019–2025 | Below |
| Taiwan | TFDA | Manufacturer | OSSEOFUSE INTERNATIONAL INC.OsseoFuse International Inc. | 4 | 2018–2022 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Osseofuse International Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | HexaPLUS SHexaPLUS S OneDrill Implant System | 2011 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | HexaPLUS SHexaPLUS S OneDrill Implant System | 2011 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Osseofuse International Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Osseofuse, Inc. (2), Dynamic Innovations, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 19 Sep 2014 | K133050 | ONE PLUS IMPLANT SYSTEM | Osseofuse, Inc. | DZE Root-Form Endosseous Implant |
| 31 Oct 2013 | K131748 | OSSEOFUSE DENTAL IMPLANT SYSTEM | Osseofuse, Inc. | DZE Root-Form Endosseous Implant |
| 14 Jul 2011 | K110577 | OSSEOFUSE DENTAL IMPLANT SYSTEM | Dynamic Innovations, Inc. | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Osseofuse International Inc.FDA reg. 3008494722 | Las Vegas, NV, United States | Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10033351). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.