Manufacturer registered with FDA
Surcam Medical Devices and Developments Ltd
Nahariya, Israel. Lists 4 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 4
- Brands and models
- 4
- 510(k) clearances
- 12025–2025
- 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 Surcam Medical Devices and Developments 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 | Surcam Medical Devices and Developments Ltd | 1 clearances | 2025–2025 | Below |
| Israel | AMAR | Manufacturer | SURCAM Medical Devices and Developments 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 Surcam Medical Devices and Developments 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 | Surcam Dental Implant System | 2026 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Surcam Dental Implant Tools and Accessories | 2026 |
| Endosseous Dental Implant AbutmentNHA · Class 2 | Implant abutments | Maker | Surcam Dental Implant System | 2026 |
| Non-Irrigation Endosseous Dental Implant Drill BitsQRQ · Class 1 | Implant instruments & surgical kits | Maker | Surcam dental implant drills | 2026 |
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 |
|---|---|---|
| SURCAM MEDICAL DEVICES AND DEVELOPMENTS LTDFDA reg. 3043585140 | Nahariya Northern, Israel | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10095125). 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.