Manufacturer registered with FDA
Carmex - Precision Tools Ltd.
Maalot, Israel. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 14
- 510(k) clearances
- 0as applicant
- Markets registered in
- 6281 registrations outside the US
- Establishments
- 1Israel
Registered in 6 markets
Where regulators' registries name Carmex - Precision Tools 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 | Carmex - Precision Tools Ltd. | 1 device types | — | Below |
| Colombia | INVIMA | Manufacturer | CARMEX PRECISION TOOLS LTDCARMEX PRECISION TOOLS LTD. | 274 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | CARMEX PRECISION TOOLS LTD. | 3 | 2015–2021 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Carmex Precision Tools Ltd. | 2 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Carmex Precision Tools Ltd. | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Carmex Precision Tools Ltd. | 1 | 2014–2014 | 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 Carmex - Precision Tools 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 |
|---|---|---|---|---|
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | Conical Drills with External IrrigationConical Implant Drills with External IrrigationConical Implants Drills with Internal IrrigationImplant DrillsImplant Drills and AccessoriesImplant Drills with External IrrigationImplant Drills with Integral StoppersInternally Irrigated Implant DrillsInternally Irrigated Long Implant DrillsInternally Irrigated Short Implant Drills Long Implants 4 moreLong Implants Drills with External IrrigationParallel Drills with External IrrigationParallel Drills with Internal IrrigationShort Implants Drills with External Irrigation | 2024 |
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 |
|---|---|---|
| CARMEX - PRECISION TOOLS LTD.FDA reg. 3009747037 | Maalot Northern, Israel | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10042249). 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.