Not currently registered with FDA under this name

Ustomed Instrumente Ulrich Storz GmbH & Co. KG

Tuttlingen, Germany. Named as applicant on 1 dental 510(k) clearance between 2025 and 2025. 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
12025–2025
Markets registered in
627 registrations outside the US
Establishments
0—
2025: 120102020

510(k) clearances per year, 2007–2026

Registered in 6 markets

Where regulators' registries name Ustomed Instrumente Ulrich Storz GmbH & Co. KG as the manufacturer or the registration holder of a device.

All markets
United States: 1 clearancesCanada: 12 registrationsAustralia: 7 registrationsTaiwan: 4 registrationsSerbia: 2 registrationsUnited Kingdom: 2 registrations
RegisteredHome: GermanyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantUstomed Instrumente Ulrich Storz GmbH & Co. KG1 clearances2025–2025Below
CanadaHealth CanadaRegistration holderUSTOMED INSTRUMENTE ULRICH STORZ GMBH & CO.KG122017–2018Pure Global AI
AustraliaTGAManufacturerUstomed Instrumente Ulrich Storz GmbH & Co KG72025–2026Pure Global AI
TaiwanTFDAManufacturerUSTOMED INSTRUMENTE, ULRICH STORZ GMBH & CO. KG42015–2023Pure Global AI
SerbiaALIMSManufacturerUSTOMED INSTRUMENTE Ulrich Storz GmbH & Co. KG22025–2025Pure Global AI
United KingdomMHRAManufacturerUSTOMED INSTRUMENTE Ulrich Storz GmbH & Co. KG2—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 Ustomed Instrumente Ulrich Storz GmbH & Co. KG as the applicant.

Decided510(k)DeviceDevice type
27 Jun 2025K243190USTOMED Bone Fixation/Bone Augmentation Systems - PINDZL Intraosseous Fixation Screw

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.