Manufacturer registered with FDA
Medical Systems and Devices International Ltd.
Kiryat Ata, Israel. Lists 5 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 5
- Brands and models
- 5
- 510(k) clearances
- 12020–2020
- Markets registered in
- 32 registrations outside the US
- Establishments
- 1Israel
510(k) clearances per year, 2007–2026
Registered in 3 markets
Where regulators' registries name Medical Systems and Devices International 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 | Medical Systems and Devices International Ltd. | 1 clearances | 2020–2020 | Below |
| Israel | AMAR | Manufacturer | Medical Systems and Devices International Ltd. | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Medical Systems and Devices International Ltd. | 1 | 2022–2022 | 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 Medical Systems and Devices International 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 |
|---|---|---|---|---|
| Root-Form Endosseous ImplantDZE · Class 2 | Dental implants | Maker | Alef, Kaf, Taf MSDI Dental Implants System | 2021 |
| All Precision AttachmentEGG · Class 1 | — | Maker | Attachments, precision attachment | 2021 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | MSDI Dental Tools | 2018 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Dental Accessories | 2021 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Alef, Kaf, Taf MSDI Dental Implants System | 2021 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MEDICAL SYSTEMS AND DEVICES INTERNATIONAL LTD.FDA reg. 3013167159 | Kiryat Ata Haifa, Israel | Complaint file establishment, Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10059177). 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.