Not currently registered with FDA under this name
Deldent , Ltd.
Petach Tikvah, Israel. Named as applicant on 6 dental 510(k) clearances between 2001 and 2002. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 62001–2002
- Markets registered in
- 33 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 3 markets
Where regulators' registries name Deldent , Ltd. 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 | Deldent , Ltd. | 6 clearances | 2001–2002 | Below |
| Taiwan | TFDA | Manufacturer | DELDENT LTD. | 2 | 2006–2007 | Pure Global AI |
| Israel | AMAR | Manufacturer | Deldent Limited | 1 | — | 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 Deldent , Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 19 Feb 2002 | K014252 | JETSTREAM | KOJ Airbrush |
| 19 Feb 2002 | K014249 | JETPOLISHER | KOJ Airbrush |
| 29 Jan 2002 | K014245 | JETSONIC 2000 | KOJ Airbrush |
| 24 Jan 2002 | K014238 | DELSONIC 2000 | ELC Ultrasonic Scaler |
| 10 Jan 2002 | K013969 | MINIBLASTER | KOJ Airbrush |
| 5 Jun 2001 | K011179 | DELDENT ULTRASONIC INSERTS | ELC Ultrasonic Scaler |
Some of these clearances are listed with FDA today by another company: Dell Dent Ltd. (6), Young Innovations Inc (3).
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.