Not currently registered with FDA under this name
Techfit Digital Surgery, Inc.
Daytona Beach, FL, United States. Named as applicant on 2 dental 510(k) clearances between 2023 and 2024. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 22023–2024
- Markets registered in
- 25 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name Techfit Digital Surgery, 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 | Applicant | Techfit Digital Surgery, Inc. | 2 clearances | 2023–2024 | Below |
| Saudi Arabia | SFDA | Manufacturer | TECHFIT DIGITAL SURGERY , Inc | 5 | — | 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
510(k) clearances
Clearances on which FDA names Techfit Digital Surgery, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 11 Dec 2024 | K242263 | TECHFIT DISRP® System | DZJ Manual Wire Driver and Bone Drill |
| 23 Jun 2023 | K230276 | TECHFIT DISRP® System | DZJ Manual Wire Driver and Bone Drill |
Some of these clearances are listed with FDA today by another company: Acumed LLC (2).
Sources
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 of the most recent filing, which can be a US agent.