FDA Registration
Active
🇩🇪 Germany
EXOCAD GMBH
Reg #: 3011521456
·
FEI: 3011521456
·
Expires 2026
Products
4
Proprietary Names
8
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- EXOCAD GMBH
- Registration Number
- 3011521456
- FEI Number
- 3011521456
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Rosa-Parks-Str. 2
- City
- Darmstadt Hesse
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K193352
Owner / Operator
- Firm Name
- exocad GmbH
- Operator Number
- 10055196
- Address
- Rosa-Parks-Str. 2
- City
- Darmstadt
- State
- Hesse
- Postal Code
- 64295
- Country
- DE
- Correspondent
- Stefan O Walter
US Agent
- Business Name
- EXOCAD AMERICA, INC.
- Contact Name
- Mary Collington
- Address
- 301 Edgewater Pl Ste 330
- City
- Wakefield
- State
- MA
- ZIP
- 01880
- Country
- US
- [email protected]
- Phone
- 855 3964223
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Medical Device Data System | OUG | Class 1 | General Hospital | No | 2017-06-19 |
| System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | NOF | Class 2 | Dental | No | 2017-10-20 |
| Dental Abutment Design Software For Dental Laboratory | PNP | Class 2 | Dental | No | 2021-10-15 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2019-08-21 |
Proprietary Names
DentalDB
ChairsideCAD
Ceramill Mind DRS
AbutmentCAD
Implant Module
Ceramill Mind M-Plant
PlanCAD Premium AbutmentCAD
exoplan
Establishment Types
Manufacture Medical Device