Not currently registered with FDA under this name

Medical Instinct Deutschland GmbH

Bovenden, Germany. Named as applicant on 2 dental 510(k) clearances between 2019 and 2021. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
22019–2021
Markets registered in
34 registrations outside the US
Establishments
0—
2019: 12021: 120102020

510(k) clearances per year, 2007–2026

Registered in 3 markets

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

All markets
United States: 2 clearancesTaiwan: 3 registrationsEuropean Union: 1 registrations
RegisteredHome: GermanyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantMedical Instinct Deutschland GmbH2 clearances2019–2021Below
TaiwanTFDAManufacturerMedical Instinct Deutschland GmbH32017–2018Pure Global AI
European UnionEUDAMEDManufacturerMedical Instinct® Deutschland GmbH1—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 Medical Instinct Deutschland GmbH as the applicant.

Decided510(k)DeviceDevice type
14 May 2021K200573BoneTrust Mini Implant SystemDZE Root-Form Endosseous Implant
11 Mar 2019K182313BoneTrust 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.