Manufacturer registered with FDA

RZ Medizintechnik GmbH

Tuttlingen, Germany. Lists 11 dental device types with FDA across 1 registered establishment.

FDA owner/operator9010855Contract manufacturerManufacturer
Device types listed
11
Brands and models
0
510(k) clearances
0as applicant
Markets registered in
164,160 registrations outside the US
Establishments
1Germany

Registered in 16 markets

Where regulators' registries name RZ Medizintechnik GmbH as the manufacturer or the registration holder of a device.

All markets
United States: 11 device types listedThailand: 2,219 registrationsSaudi Arabia: 651 registrationsCanada: 303 registrationsSouth Korea: 293 registrationsUnited Kingdom: 191 registrationsAustralia: 149 registrationsSerbia: 110 registrationsBrazil: 68 registrationsPeru: 67 registrationsCosta Rica: 55 registrationsTaiwan: 32 registrationsColombia: 12 registrationsEuropean Union: 6 registrationsIsrael: 3 registrationsHong Kong: 1 registrations
RegisteredHome: GermanyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerRZ Medizintechnik GmbH11 device types—Below
ThailandThai FDAManufacturerRZ MEDIZINTECHNIK GMBH2,219—Pure Global AI
Saudi ArabiaSFDAManufacturerRZ-Medizintechnik GmbH651—Pure Global AI
CanadaHealth CanadaRegistration holderRZ MEDIZINTECHNIK GMBH3032001–2026Pure Global AI
South KoreaMFDSManufacturerRZ-Medizintechnik GmbHRZ Medizintechnik GmbH · RZ MEDIZINTECHNIK GMBH · +22931999–2026Pure Global AI
United KingdomMHRAManufacturerRZ Medizintechnik GmbH191—Pure Global AI
AustraliaTGAManufacturerRZ Medizintechnik GmbH1492007–2023Pure Global AI
SerbiaALIMSManufacturerRZ Medizintechnik GmbH1102024–2026Pure Global AI
BrazilANVISAManufacturerRZ MEDIZINTECHNIK GMBH682008–2026Pure Global AI
PeruDIGEMIDManufacturerRZ MEDIZINTECHNIK GmbH672017–2026Pure Global AI
Costa RicaMinisterio de SaludManufacturerRZ Medizintechnik GmbHRZ MEDIZINTECHNIK GmbH55—Pure Global AI
TaiwanTFDAManufacturerRZ MEDIZINTECHNIK GMBH322005–2025Pure Global AI
ColombiaINVIMARegistration holderRZ MEDIZINTECHNIK GMBHRZ-MEDIZINTECHNIK GMBH12—Pure Global AI
European UnionEUDAMEDManufacturerRZ-Medizintechnik GmbH6—Pure Global AI
IsraelAMARManufacturerRZ Medizintechnik GmbHRZ MEDIZINTECHNIK3—Pure Global AI
Hong KongMDDManufacturerRZ Medizintechnik GmbH12026–2026Pure 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

Devices listed with FDA

What RZ Medizintechnik GmbH currently lists, by FDA device type, with the brand and model names on the listing.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

Registered establishments

EstablishmentLocationWhat it does
RZ MEDIZINTECHNIK GMBHFDA reg. 9680718TUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer, Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 9010855). 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.