Dental Device Guide
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Not currently registered with FDA under this name

Newmedical Technology, Inc.

Waukesha, WI, United States. Named as applicant on 1 dental 510(k) clearance between 2003 and 2003. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
12003–2003
Markets registered in
1032 registrations outside the US
Establishments
0—
2003: 1200020102020

510(k) clearances per year, 2000–2026

Registered in 10 markets

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

All markets
United States: 1 clearancesCosta Rica: 11 registrationsIsrael: 5 registrationsSaudi Arabia: 5 registrationsEuropean Union: 3 registrationsBrazil: 2 registrationsSouth Korea: 2 registrationsTaiwan: 2 registrationsAustralia: 1 registrationsColombia: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantNewmedical Technology, Inc.1 clearances2003–2003Below
Costa RicaMinisterio de SaludManufacturerNEWMEDICAL TECHNOLOGY, INC.11—Pure Global AI
IsraelAMARManufacturerNewMedical Technology, Inc.NEWMEDICAL TECHNOLOGY5—Pure Global AI
Saudi ArabiaSFDAManufacturerNewmedical Technology, Inc.NewMedical Technology, Inc.5—Pure Global AI
European UnionEUDAMEDManufacturerNewmedical Technology, Inc.3—Pure Global AI
BrazilANVISAManufacturerNEWMEDICAL TECHNOLOGY, INC.22018–2020Pure Global AI
South KoreaMFDSManufacturerNewMedical Technology, Inc.22011–2020Pure Global AI
TaiwanTFDAManufacturerNEWMEDICAL TECHNOLOGY, INC.22010–2011Pure Global AI
AustraliaTGAManufacturerNewMedical Technology Inc12012–2012Pure Global AI
ColombiaINVIMAManufacturerNEWMEDICAL TECHNOLOGY INC1—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

510(k) clearances

Clearances on which FDA names Newmedical Technology, Inc. as the applicant.

Decided510(k)DeviceDevice type
3 Dec 2003K030485NEWMEDICAL MICRO BONE DISTRACTOR/FIXATORMQN External Mandibular Fixator and/or Distractor

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.