Manufacturer registered with FDA
Synoross
Glendale, CA, United States. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1United States
Devices listed with FDA
What Synoross 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 | OsseOne Dental Implant System | 2019 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | OsseOne Dental Implant System | 2019 |
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
Synoross 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: Synoross Dba Osseone (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 8 May 2025 | K233271 | OsseOne Dental Implant System | Synoross Dba Osseone | DZE Root-Form Endosseous Implant |
| 15 Feb 2019 | K182293 | OsseOne Dental Implant System | Synoross Dba Osseone | DZE Root-Form Endosseous Implant |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SYNOROSSFDA reg. 3015620565 | Glendale, CA, United States | Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10060947). 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.