Data / Medical devices / Germany / Exocad GMBH
Exocad GMBH: FDA-registered device maker in Darmstadt Hesse, Germany, 2 510(k) clearances
Exocad GMBH is registered with the FDA (registration 3011521456) in Darmstadt Hesse, Germany. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 21, 2021. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011521456
- Address
- Rosa-Parks-Str. 2, Darmstadt Hesse, Germany, 64295
- Owner or operator
- exocad GmbH (10055196)
- Roles
- Manufacturer
- First device listed
- June 19, 2017
- Registered through
- 2026
- Brand names listed
- AbutmentCAD, Ceramill Mind DRS, Ceramill Mind M-Plant, ChairsideCAD, DentalDB, Implant Module, PlanCAD Premium AbutmentCAD, exoplan
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dental Abutment Design Software For Dental Laboratory | PNP | 2 | Manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 21, 2021 | K193352 | AbutmentCAD | PNP | Substantially Equivalent | Exocad GmbH | accessdata.fda.gov |
| August 6, 2019 | K183458 | exoplan 2.3 | LLZ | Substantially Equivalent | Exocad GmbH | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 17, 2023 | 92921 | Class II | Ongoing | exoplan version 3.1 Rijeka Software -A medical software, intended to support the pre-operative planning of dental implants using the visualization of the implant placement within images of the patents anatomy. | A software library filtering error has been discovered which occurs when users are using the Step-by-Step Full Drill Protocol export functionality of exoplan 3.1 Rijeka. When a guided surgery treatment approach is selected, along with a Step-by-Step Full Drill Protocol export implant library, exoplan software does not filter out unsupported sleeve height pos | accessdata.fda.gov |
Compare with other makers
- All makers of Medical Device Data System
- All makers of System, Image Processing, Radiological
- All makers of System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
- All makers of Dental Abutment Design Software For Dental Laboratory
Updated September 25, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.