Not currently registered with FDA under this name

Syntec Scientific Corporation

Chang Hua, Taiwan. Named as applicant on 3 dental 510(k) clearances between 2009 and 2021. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
32009–2021
Markets registered in
32 registrations outside the US
Establishments
0—
2009: 12012: 12021: 1200020102020

510(k) clearances per year, 2000–2026

Registered in 3 markets

Where regulators' registries name Syntec Scientific Corporation as the manufacturer or the registration holder of a device.

All markets
United States: 3 clearancesAustralia: 1 registrationsColombia: 1 registrations
RegisteredHome: TaiwanOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantSyntec Scientific Corporation3 clearances2009–2021Below
AustraliaTGAManufacturerSyntec Scientific Corporation12018–2018Pure Global AI
ColombiaINVIMAManufacturerSYNTEC SCIENTIFIC CORP.1—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 Syntec Scientific Corporation as the applicant.

Decided510(k)DeviceDevice type
17 Sep 2021K202790Syntec Orthodontic Mini Screw Extended SystemOAT Orthodontic Endosseous Implant
20 Dec 2012K111189SYNTEC DENTAL IMPLANTDZE Root-Form Endosseous Implant
18 Jun 2009K090476SYNTEC ORTHODONTIC MINI SCREWOAT Orthodontic Endosseous Implant

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.