Manufacturer registered with FDA

DENTIN Implants Technologies Ltd.

Mizpe Aviv, Israel. Lists 5 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10041411ManufacturerSpecification developer
Device types listed
5
Brands and models
76
510(k) clearances
12012–2012
Markets registered in
45 registrations outside the US
Establishments
1Israel
2012: 120102020

510(k) clearances per year, 2007–2026

Registered in 4 markets

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

All markets
United States: 5 device types listedChina: 3 registrationsIsrael: 1 registrationsTaiwan: 1 registrations
RegisteredHome: IsraelOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerDENTIN Implants Technologies Ltd.1 clearances2012–2012Below
ChinaNMPARegistration holder丹特因DENTIN IMPLANTS TECHNOLOGIES LTD3—Pure Global AI
IsraelAMARManufacturerDENTIN IMPLANTS TECHNOLOGIES LTD1—Pure Global AI
TaiwanTFDAManufacturerDENTIN IMPLANTS TECHNOLOGIES LTD.12014–2014Pure 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 DENTIN Implants Technologies 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 DrillCountersink Surgical DrillDrill / CHEAT DrillDrill setMarking DrillSurgical Trephine Drill
2012
Root-Form Endosseous ImplantDZE · Class 2Dental implantsMaker
Abutment SystemAesthetic Minor UnitAnatomic Angulated Titanium AbutmentAnatomic Titanium AbutmentAngular CurveAngular Curve Narrow ThreeAngular multi unitAngular smoothAngulated Titanium AbutmentBall Attachment
16 more
Ball MinorBall Minor Angular / CLIKBITEBall Multi AngularBall wideClassic Dental Implant / Vintage / Vintage IIEsthetic Connection AbutmentHealing CapImmediate Temporary ConicalLeaf Titanium AbutmentOne piece Dental implantPrestige Dental Implant / Eminence / Eminence IIRapid Dental Implant / Razor / Razor IISilicon CapSlim Titanium AbutmentTitanium Castable AbutmentsWise Click / CLIKBITE Locator
2012
Dental BurEJL · Class 1Dental burs & diamondsMaker
CountersinkDrill / CHEAT DrillMarking DrillSurgical Trephine
2015
Endosseous Dental Implant AccessoriesNDP · Class 1Implant instruments & surgical kitsMaker
Clip mountDepth probeDrill ExtensionHammerHand tissue punchHex driverMotor mountmount keyOsteotomesParallel pin
4 more
RatchetScrew DriverTool KeyTorque Ratchet
2012
Endosseous Dental Implant AbutmentNHA · Class 2Implant abutmentsMaker
Abutment SystemAesthetic Minor UnitAnatomic Angulated Titanium AbutmentAnatomic Titanium AbutmentAngular CurveAngular Curve Narrow ThreeAngular multi unitAngular smoothAngulated Titanium AbutmentBall Attachment
16 more
Ball MinorBall Minor Angular / CLIKBITEBall Multi AngularBall wideClassic Dental Implant / Vintage / Vintage IIEsthetic Connection AbutmentHealing CapImmediate Temporary ConicalLeaf Titanium AbutmentOne piece Dental implantPrestige Dental Implant / Eminence / Eminence IIRapid Dental Implant / Razor / Razor IISilicon CapSlim Titanium AbutmentTitanium Castable AbutmentsWise Click / CLIKBITE Locator
2012

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 DENTIN Implants Technologies Ltd. as the applicant.

Decided510(k)DeviceDevice type
5 Jul 2012K120530DENTIN DENTAL IMPLANTS SYSTEM: RAPID, CLASSIC, PRESTIGE, ONE PIECE, DENTIN DENTAL ABUTMENT SYSTEM / DENTIN RESTORATION SDZE Root-Form Endosseous Implant

Registered establishments

EstablishmentLocationWhat it does
DENTIN IMPLANTS TECHNOLOGIES LTD.FDA reg. 3009737865Mizpe Aviv Northern, IsraelManufacturer, Specification developer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10041411). 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.