Manufacturer registered with FDA

Iq Implants , Ltd.

Omer, Israel. Lists 4 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10045610ManufacturerSpecification developer
Device types listed
4
Brands and models
64
510(k) clearances
12013–2013
Markets registered in
32 registrations outside the US
Establishments
1Israel
2013: 120102020

510(k) clearances per year, 2007–2026

Registered in 3 markets

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

All markets
United States: 4 device types listedIsrael: 1 registrationsTaiwan: 1 registrations
RegisteredHome: IsraelOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerIq Implants , Ltd.1 clearances2013–2013Below
IsraelAMARRegistration holderIQ Implants Ltd.1—Pure Global AI
TaiwanTFDAManufacturerI.Q. IMPLANTS LTD12017–2017Pure 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 Iq Implants , Ltd. currently lists, by FDA device type, with the brand and model names on the listing.

Device typeCategoryRoleBrands and modelsListed since
Intraoral Dental DrillDZA · Class 1Surgical drills & motorsMaker
Conical Drills with External IrrigationConical Drills with Internal IrrigationCountersinkCylindrical Drills Internal IrrigatedDrill Extender ExternalDrill Extender InternalDrills with External IrrigationDrills with Internal IrrigationLance Pilot DrillMarking Drill External Irrigation
6 more
Marking Drill Internal IrrigationPunch DrillShort Drills with External IrrigationShort Drills with Internal IrrigationStoppersTrephine Drill
2013
Root-Form Endosseous ImplantDZE · Class 2Dental implantsMaker
Aesthetic AbutmentsAnatomic Angled Abutments 15 DegreesAnatomic Angled Abutments 25 DegreesAngled Abutments 15 DegreesAngled Abutments 25 DegreesBall AbutmentsConnection AbutmentsEasy Lock AbutmentsHealing Cap for Aesthetic AbutmentHealing Caps
9 more
MASTER ImplantSlim Angled Abutment 15 DegreesSlim Healing CapsSlim Straight AbutmentsSMART ImplantStraight AbutmentsStraight Abutments with CuffStraight Anatomic AbutmentsUCLA Abutment titanium base
2013
Endosseous Dental Implant AccessoriesNDP · Class 1Implant instruments & surgical kitsMaker
Hand Hex Drivers 1.25Hex Driver 1.77mmHex Drivers 1.25 mm for Ratchet WrenchHex Drivers 2.5mm for Ratchet WrenchImplant AnalogImpression Transfer (for open tray ,closed tray)Parallel Guide Short/LongPlastic Castable AbutmentsRatchet WrenchUniversal Torque
2013
Endosseous Dental Implant AbutmentNHA · Class 2Implant abutmentsMaker
Aesthetic AbutmentsAnatomic Angled Abutments 15 DegreesAnatomic Angled Abutments 25 DegreesAngled Abutments 15 DegreesAngled Abutments 25 DegreesBall AbutmentsConnection AbutmentsEasy Lock AbutmentsHealing Cap for Aesthetic AbutmentHealing Caps
9 more
MASTER ImplantSlim Angled Abutment 15 DegreesSlim Healing CapsSlim Straight AbutmentsSMART ImplantStraight AbutmentsStraight Abutments with CuffStraight Anatomic AbutmentsUCLA Abutment titanium base
2013

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 Iq Implants , Ltd. as the applicant.

Decided510(k)DeviceDevice type
14 Nov 2013K130829IQ IMPLANTS; IQ IMPLANTS; IQ IMPLANTS ABUTMENTSDZE Root-Form Endosseous Implant

Registered establishments

EstablishmentLocationWhat it does
IQ IMPLANTS LTDFDA reg. 3010610960Omer Southern, IsraelManufacturer, Specification developer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10045610). 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.