Manufacturer registered with FDA
Saliwell Ltd.
Harutzim, Israel. Lists 2 dental device types with FDA across 1 registered establishment, and holds 4 510(k) clearances as applicant.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 42017–2023
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1Israel
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name Saliwell 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 | Saliwell Ltd. | 4 clearances | 2017–2023 | Below |
| Israel | AMAR | Registration holder | Saliwell Ltd. | 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
Devices listed with FDA
What Saliwell 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 |
|---|---|---|---|---|
| Over the Counter Electrical Salivary Stimulatory SystemQTT · Class 2 | — | Maker | SaliPen | 2023 |
| Salivary System StimulatorLTF · Class 2 | — | Maker | SaliPen | 2019 |
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 Saliwell Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 13 Dec 2023 | K232063 | SaliPen | QTT Over the Counter Electrical Salivary Stimulatory System |
| 30 Aug 2022 | K220618 | SaliPen | QTT Over the Counter Electrical Salivary Stimulatory System |
| 6 Nov 2018 | K180838 | SaliPen | LTF Salivary System Stimulator |
| 17 Feb 2017 | K160799 | GenNarino | LTF Salivary System Stimulator |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SALIWELL LTD.FDA reg. 3015282800 | Harutzim Central, Israel | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10059893). 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.