Manufacturer registered with FDA
Dell Dent Ltd.
Petach Tikva, Israel. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 23 registrations outside the US
- Establishments
- 1Israel
Registered in 2 markets
Where regulators' registries name Dell Dent 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 | Manufacturer | Dell Dent Ltd. | 3 device types | — | Below |
| United Kingdom | MHRA | Manufacturer | Dell Dent Ltd | 3 | — | 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 Dell Dent Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| AirbrushKOJ · Class 2 | — | Maker | AIRBRUSH | 1994 |
| Ultrasonic ScalerELC · Class 2 | Ultrasonic scalers | Maker | AIRBRUSH | 2007 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | AIRBRUSH | 2020 |
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
Dell Dent Ltd. 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: Deldent , Ltd. (6).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 19 Feb 2002 | K014249 | JETPOLISHER | Deldent , Ltd. | KOJ Airbrush |
| 19 Feb 2002 | K014252 | JETSTREAM | Deldent , Ltd. | KOJ Airbrush |
| 29 Jan 2002 | K014245 | JETSONIC 2000 | Deldent , Ltd. | KOJ Airbrush |
| 24 Jan 2002 | K014238 | DELSONIC 2000 | Deldent , Ltd. | ELC Ultrasonic Scaler |
| 10 Jan 2002 | K013969 | MINIBLASTER | Deldent , Ltd. | KOJ Airbrush |
| 5 Jun 2001 | K011179 | DELDENT ULTRASONIC INSERTS | Deldent , Ltd. | ELC Ultrasonic Scaler |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| DELL DENT LTD.FDA reg. 9616762 | PETACH TIKVAH Central, Israel | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9009616). 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.