Not currently registered with FDA under this name

Apexum , Ltd.

Or Yehuda, Israel. Named as applicant on 1 dental 510(k) clearance between 2009 and 2009. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
12009–2009
Markets registered in
21 registrations outside the US
Establishments
0—
2009: 1200020102020

510(k) clearances per year, 2000–2026

Registered in 2 markets

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

All markets
United States: 1 clearancesIsrael: 1 registrations
RegisteredHome: IsraelOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantApexum , Ltd.1 clearances2009–2009Below
IsraelAMARManufacturerAPEXUM 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

510(k) clearances

Clearances on which FDA names Apexum , Ltd. as the applicant.

Decided510(k)DeviceDevice type
21 Apr 2009K082325APEXUM ABLATOREKX Ac-Powered Direct Drive Handpiece

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.