Dental Device Guide
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Manufacturer registered with FDA

OrangeCAD Med GmbH

Karlsruhe, Germany. Lists 2 dental device types with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.

FDA owner/operator10090072Manufacturer1 clearance in five years
Device types listed
2
Brands and models
2
510(k) clearances
12025–2025
Markets registered in
25 registrations outside the US
Establishments
1Germany
2025: 120102020

510(k) clearances per year, 2007–2026

Registered in 2 markets

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

All markets
United States: 2 device types listedEuropean Union: 5 registrations
RegisteredHome: GermanyOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAManufacturerOrangeCAD Med GmbH1 clearances2025–2025Below
European UnionEUDAMEDManufacturerOrangeCAD Med GmbH5—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

Devices listed with FDA

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

Device typeCategoryRoleBrands and modelsListed since
Endosseous Dental Implant AccessoriesNDP · Class 1Implant instruments & surgical kitsMaker
Dental Implant Accesories
2024
Endosseous Dental Implant AbutmentNHA · Class 2Implant abutmentsMaker
OrangeCAD Med Abutments
2026

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

510(k) clearances

Clearances on which FDA names OrangeCAD Med GmbH as the applicant.

Decided510(k)DeviceDevice type
23 Dec 2025K253312OrangeCAD Med AbutmentsNHA Endosseous Dental Implant Abutment

Registered establishments

EstablishmentLocationWhat it does
ORANGECAD MED GMBHFDA reg. 3030488649Karlsruhe Baden-Wurttemberg, GermanyComplaint file establishment, Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10090072). 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.