Not currently registered with FDA under this name

Diplomat Dental S.R.O.

Austin, TX, United States. Named as applicant on 1 dental 510(k) clearance between 2013 and 2013. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
12013–2013
Markets registered in
712 registrations outside the US
Establishments
0—
2013: 120102020

510(k) clearances per year, 2007–2026

Registered in 7 markets

Where regulators' registries name Diplomat Dental S.R.O. as the manufacturer or the registration holder of a device.

All markets
United States: 1 clearancesSaudi Arabia: 4 registrationsEuropean Union: 3 registrationsAustralia: 2 registrationsChina: 1 registrationsSerbia: 1 registrationsUnited Kingdom: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantDiplomat Dental S.R.O.1 clearances2013–2013Below
Saudi ArabiaSFDAManufacturerDiplomat Dental s.r.o4—Pure Global AI
European UnionEUDAMEDManufacturerDIPLOMAT DENTAL s.r.o.3—Pure Global AI
AustraliaTGAManufacturerDiplomat Dental s.r.o22012–2018Pure Global AI
ChinaNMPARegistration holder外交官牙科有限责任公司DIPLOMAT DENTAL s.r.o.1—Pure Global AI
SerbiaALIMSManufacturerDIPLOMAT DENTAL s.r.o.12024–2024Pure Global AI
United KingdomMHRAManufacturerDIPLOMAT DENTAL s.r.o.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 Diplomat Dental S.R.O. as the applicant.

Decided510(k)DeviceDevice type
30 Oct 2013K130534DIPLOMATEIA Operative Dental Unit

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.