Manufacturer registered with FDA
RODO Medical, Inc.
Southlake, TX, United States. Lists 3 dental device types with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 3
- Brands and models
- 5
- 510(k) clearances
- 32016–2020
- Markets registered in
- 330 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name RODO Medical, 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 | RODO Medical, Inc. | 3 clearances | 2016–2020 | Below |
| Canada | Health Canada | Registration holder | RODO MEDICAL, INC. | 23 | 2017–2024 | Pure Global AI |
| South Korea | MFDS | Manufacturer | RODO Medical. IncRodo medical · RODO Medical Inc. | 7 | 2023–2023 | 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 RODO Medical, 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 |
|---|---|---|---|---|
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Rodo Abutment SystemRodo SmilelocSmilekey | 2016 |
| Preformed AnchorEJX · Class 1 | — | Maker | Smileclip | 2015 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Rodo Abutment Accesories | 2016 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names RODO Medical, Inc. as the applicant.
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| RODO MEDICAL, INCFDA reg. 3009742323 | Troy, MI, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10044830). 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.