Dental Device Guide
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Not currently registered with FDA under this name

Microtek Medical, Inc.

Columbus, MS, United States. Named as applicant on 1 dental 510(k) clearance between 1987 and 1987. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
11987–1987
Markets registered in
14231 registrations outside the US
Establishments
0—
1987: 119801990200020102020

510(k) clearances per year, 1980–2026

Registered in 14 markets

Where regulators' registries name Microtek Medical, Inc. as the manufacturer or the registration holder of a device.

All markets
United States: 1 clearancesCanada: 77 registrationsSaudi Arabia: 53 registrationsAustralia: 27 registrationsUnited Kingdom: 21 registrationsIsrael: 19 registrationsBrazil: 7 registrationsColombia: 6 registrationsSouth Korea: 6 registrationsTaiwan: 6 registrationsEuropean Union: 3 registrationsChina: 2 registrationsPeru: 2 registrationsSerbia: 2 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantMicrotek Medical, Inc.1 clearances1987–1987Below
CanadaHealth CanadaRegistration holderMICROTEK MEDICAL LLC771999–2025Pure Global AI
Saudi ArabiaSFDAManufacturerMicrotek Medical Inc.Microtek Medical BV, · Microtek Medical, Inc. · +153—Pure Global AI
AustraliaTGAManufacturerMicrotek Medical IncMicrotek Medical LLC · Microtek Medical BV272003–2026Pure Global AI
United KingdomMHRAManufacturerMicrotek Medical LLCMicrotek Medical B.V.21—Pure Global AI
IsraelAMARManufacturerMicrotek Medical, Inc.Microtek Medical LLC · Microtek Medical Inc. · +219—Pure Global AI
BrazilANVISAManufacturerMICROTEK MEDICAL INCMICROTEK MEDICAL72010–2015Pure Global AI
ColombiaINVIMAManufacturerMICROTEK MEDICAL INCMICROTEK MEDICAL LLC6—Pure Global AI
South KoreaMFDSManufacturerMicrotek Medical, Inc.Microtek Medical Inc.62005–2013Pure Global AI
TaiwanTFDAManufacturerMICROTEK MEDICAL, INCMICROTEK MEDICAL, INC. · Microtek Medical LLC62006–2021Pure Global AI
European UnionEUDAMEDManufacturerMicrotek Medical LLCMicrotek Medical B.V.3—Pure Global AI
ChinaNMPARegistration holder迈科泰克医疗公司Microtek Medical LLC麦科太克医疗公司Microtek Medical LLC2—Pure Global AI
PeruDIGEMIDManufacturerMICROTEK MEDICAL INCMICROTEK MEDICAL LLC22025–2026Pure Global AI
SerbiaALIMSManufacturerMicrotek Medical B.V.Microtek Medical LLC22023–2025Pure 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 Microtek Medical, Inc. as the applicant.

Decided510(k)DeviceDevice type
23 Nov 1987K874535MICROTEK MINI-MAX DRILL SYSTEMDZI Powered Bone Drill

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.