Not currently registered with FDA under this name

Etgar Medical Instruments, Ltd.

Nahariyah, Israel. Named as applicant on 1 dental 510(k) clearance between 2017 and 2017. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
12017–2017
Markets registered in
23 registrations outside the US
Establishments
0—
2017: 120102020

510(k) clearances per year, 2007–2026

Registered in 2 markets

Where regulators' registries name Etgar Medical Instruments, Ltd. as the manufacturer or the registration holder of a device.

All markets
United States: 1 clearancesIsrael: 3 registrations
RegisteredHome: IsraelOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantEtgar Medical Instruments, Ltd.1 clearances2017–2017Below
IsraelAMARRegistration holderETGAR MEDICAL INSTRUMENTS LTD.Etgar Medical Instruments Ltd.3—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

510(k) clearances

Clearances on which FDA names Etgar Medical Instruments, Ltd. as the applicant.

Decided510(k)DeviceDevice type
14 Apr 2017K161743Etgar Dental Implant SystemDZE Root-Form Endosseous Implant

Sources

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 of the most recent filing, which can be a US agent.