Manufacturer registered with FDA
d.a.n.d metal industries north LTD
migdal tefen, P.O.B 51, Israel. Lists 3 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 3
- Brands and models
- 3
- 510(k) clearances
- 12025–2025
- Markets registered in
- 6246 registrations outside the US
- Establishments
- 1Israel
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name d.a.n.d metal industries north 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 | d.a.n.d metal industries north LTD | 1 clearances | 2025–2025 | Below |
| European Union | EUDAMED | Manufacturer | D.A.N.D Metal Industries North | 239 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | D.A.N.D. Metal Industries North Ltd | 3 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | D.A.N.D Metal Industries North Ltd.DAND Metal Industries North Ltd. | 2 | — | Pure Global AI |
| Australia | TGA | Manufacturer | DAND Metal Industries North Ltd | 1 | 2024–2024 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | DAND Metal Industries North L.T.D. | 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 d.a.n.d metal industries north 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 | DAND Dental Implant System | 2019 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | DAND Dental Implant System | 2019 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | dental implant accessories | 2025 |
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 |
|---|---|---|
| D.A.N.D METAL INDUSTRIES NORTH LTDFDA reg. 3011587630 | migdal tefen, P.O.B 51 Northern, Israel | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10056970). 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.