Not currently registered with FDA under this name

Miltex Instrument Co.

Mchenry, IL, United States. Named as applicant on 2 dental 510(k) clearances between 1981 and 1982. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
21981–1982
Markets registered in
377 registrations outside the US
Establishments
0—
1981: 11982: 119801990200020102020

510(k) clearances per year, 1980–2026

Registered in 3 markets

Where regulators' registries name Miltex Instrument Co. as the manufacturer or the registration holder of a device.

All markets
United States: 2 clearancesSouth Korea: 75 registrationsAustralia: 2 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantMiltex Instrument Co.2 clearances1981–1982Below
South KoreaMFDSManufacturerMiltex Instrument Company, Inc.Miltex Instrument Company, Inc · Miltex Instrument Company,Inc.752001–2004Pure Global AI
AustraliaTGAManufacturerMiltex Instrument Co22006–2018Pure 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 Miltex Instrument Co. as the applicant.

Decided510(k)DeviceDevice type
28 Dec 1982K823536INTRALIGEJI Cartridge Syringe
23 Oct 1981K812692FILES & REAMERSEKS Endodontic Pulp Canal File

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.