Dental Device Guide
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Manufacturer registered with FDA

Forum Engineering Technologies (96) Ltd.

Ashkelon, Israel. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10038791Manufacturer1 clearance in five years
Device types listed
2
Brands and models
4
510(k) clearances
12024–2024
Markets registered in
1087 registrations outside the US
Establishments
1Israel
2024: 120102020

510(k) clearances per year, 2007–2026

Registered in 10 markets

Where regulators' registries name Forum Engineering Technologies (96) Ltd. as the manufacturer or the registration holder of a device.

All markets
United States: 2 device types listedEuropean Union: 34 registrationsCanada: 23 registrationsTaiwan: 7 registrationsSouth Korea: 6 registrationsIsrael: 5 registrationsUnited Kingdom: 5 registrationsAustralia: 4 registrationsBrazil: 2 registrationsPeru: 1 registrations
RegisteredHome: IsraelOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerForum Engineering Technologies (96) Ltd.1 clearances2024–2024Below
European UnionEUDAMEDManufacturerForum Engineering Technologies (96) Ltd.34—Pure Global AI
CanadaHealth CanadaRegistration holderFORUM ENGINEERING TECHNOLOGIES (96) LTD.232024–2026Pure Global AI
TaiwanTFDAManufacturerFORUM ENGINEERING TECHNOLOGIES (96) LTD.Forum Engineering Technologies (96) Ltd. · FORUM ENGINEERING TECHNOLOGIES (96) LTD72015–2026Pure Global AI
South KoreaMFDSManufacturerForum Engineering Technologies(96) Ltd.Forum Engineering Technologies(96)Ltd. · Forum Engineering Technologies (96) LTD · +162001–2013Pure Global AI
IsraelAMARRegistration holderForum Engineering Technologies (96) Ltd.5—Pure Global AI
United KingdomMHRAManufacturerForum Engineering Technologies (96) Ltd5—Pure Global AI
AustraliaTGAManufacturerForum Engineering Technologies (96) Ltd42024–2026Pure Global AI
BrazilANVISAManufacturerFORUM ENGINEERING TECHNOLOGIES (96) LTD.22009–2023Pure Global AI
PeruDIGEMIDManufacturerFORUM ENGINEERING TECHNOLOGIES (96) LTDA.12024–2024Pure 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 Forum Engineering Technologies (96) Ltd. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Ac-Powered Direct Drive HandpieceEKX · Class 1Dental handpiecesMaker
EM-07 Cordless Endo MotorStatera viX-Smart Go
2024
Endosseous Dental Implant AccessoriesNDP · Class 1Implant instruments & surgical kitsMaker
Spotter
2018

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Forum Engineering Technologies (96) Ltd. as the applicant.

Decided510(k)DeviceDevice type
9 Jul 2024K232551EM-07 Cordless Endo MotorEKX Ac-Powered Direct Drive Handpiece

Registered establishments

EstablishmentLocationWhat it does
FORUM ENGINEERING TECHNOLOGIES (96) LTD.FDA reg. 3005164841Ashkelon Southern, IsraelManufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10038791). 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.