Not currently registered with FDA under this name

Medentis Medical GmbH

Bad Neuenahr-Ahrweiler, Germany. Named as applicant on 1 dental 510(k) clearance between 2024 and 2024. No establishment is registered with FDA under this exact name today.

1 clearance in five years
Device types listed
0
Brands and models
0
510(k) clearances
12024–2024
Markets registered in
6102 registrations outside the US
Establishments
0—
2024: 120102020

510(k) clearances per year, 2007–2026

Registered in 6 markets

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

All markets
United States: 1 clearancesSerbia: 43 registrationsUnited Kingdom: 40 registrationsEuropean Union: 13 registrationsChina: 5 registrationsPeru: 1 registrations
RegisteredHome: GermanyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantMedentis Medical GmbH1 clearances2024–2024Below
SerbiaALIMSManufacturermedentis medical GmbH432022–2026Pure Global AI
United KingdomMHRAManufacturermedentis medical GmbH40—Pure Global AI
European UnionEUDAMEDManufacturermedentis medical GmbH13—Pure Global AI
ChinaNMPARegistration holder门登特斯医疗器械有限责任公司medentis medical GmbH5—Pure Global AI
PeruDIGEMIDManufacturerMEDENTIS MEDICAL GmbH12022–2022Pure 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 Medentis Medical GmbH as the applicant.

Decided510(k)DeviceDevice type
5 Sep 2024K231566ICX-Implant SystemDZE Root-Form 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.