Manufacturer registered with FDA

RDJ TOV Implant Ltd

Jerusalem, Israel. Lists 3 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10091707Specification developer1 clearance in five years
Device types listed
3
Brands and models
3
510(k) clearances
12024–2024
Markets registered in
22 registrations outside the US
Establishments
1Israel
2024: 120102020

510(k) clearances per year, 2007–2026

Registered in 2 markets

Where regulators' registries name RDJ TOV Implant Ltd as the manufacturer or the registration holder of a device.

All markets
United States: 3 device types listedIsrael: 2 registrations
RegisteredHome: IsraelOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerRDJ TOV Implant Ltd1 clearances2024–2024Below
IsraelAMARManufacturerRDJ Tov Implant Ltd.2—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 RDJ TOV Implant Ltd currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Root-Form Endosseous ImplantDZE · Class 2Dental implantsMaker
TOV Dental Implant System
2024
Endosseous Dental Implant AccessoriesNDP · Class 1Implant instruments & surgical kitsMaker
TOV Dental Implant System Tools and Accessories
2025
Endosseous Dental Implant AbutmentNHA · Class 2Implant abutmentsMaker
TOV Dental Implant System
2024

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 RDJ TOV Implant Ltd as the applicant.

Decided510(k)DeviceDevice type
15 Aug 2024K240837TOV Dental Implant SystemDZE Root-Form Endosseous Implant

Registered establishments

EstablishmentLocationWhat it does
RDJ TOV IMPLANT LTDFDA reg. 3033524692Jerusalem, IsraelSpecification developer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10091707). 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.