Manufacturer registered with FDA
exocad GmbH
Darmstadt, Germany. Lists 2 dental device types with FDA across 2 registered establishments, and holds 1 510(k) clearance as applicant.
- Device types listed
- 2
- Brands and models
- 6
- 510(k) clearances
- 12021–2021
- Markets registered in
- 1156 registrations outside the US
- Establishments
- 2Germany, United States
510(k) clearances per year, 2007–2026
Registered in 11 markets
Where regulators' registries name exocad GmbH as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | exocad GmbH | 1 clearances | 2021–2021 | Below |
| Taiwan | TFDA | Manufacturer | EXOCAD GMBHexocad GmbH | 12 | 2018–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Exocad GmbH | 11 | 2018–2025 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | exocad GmbH | 8 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | exocad GmbH | 8 | 2013–2021 | Pure Global AI |
| Canada | Health Canada | Registration holder | EXOCAD GMBH | 5 | 2019–2022 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | exocad GmbH | 4 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | exocad GmbH | 3 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | EXOCAD GMBH | 2 | 2020–2020 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | EXOCAD GMBH | 2 | 2024–2024 | Pure Global AI |
| Serbia | ALIMS | Manufacturer | exocad GmbH | 1 | 2026–2026 | 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 exocad GmbH currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Computer Assisted Design and Manufacturing (Cad/Cam) of Dental Restorations Optical Impression SystemNOF · Class 2 | Intraoral scanners | Maker | Ceramill Mind DRSChairsideCAD | 2017 |
| Dental Abutment Design Software for Dental LaboratoryPNP · Class 2 | Dental design & orthodontic software | Maker | AbutmentCADCeramill Mind M-PlantImplant ModulePlanCAD Premium AbutmentCAD | 2021 |
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 exocad GmbH as the applicant, including filings under its other names.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 21 Jul 2021 | K193352 | AbutmentCAD | PNP Dental Abutment Design Software for Dental Laboratory |
Some of these clearances are listed with FDA today by another company: Proto3000 Inc. (1), Nobel Biocare Services AG (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| EXOCAD AMERICA, INC.FDA reg. 3013718526 | Wakefield, MA, United States | Complaint file establishment |
| EXOCAD GMBHFDA reg. 3011521456 | Darmstadt Hesse, Germany | Manufacturer |
Other names on FDA records
Exocad America, Inc.
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10055196). 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.