FDA Registration
Active
🇩🇪 Germany
DEGUDENT GMBH
Reg #: 9681199
·
FEI: 3003999430
·
Expires 2026
Products
8
Proprietary Names
24
Establishment Types
4
Classifications
8
Registration Details
- Registration Name
- DEGUDENT GMBH
- Registration Number
- 9681199
- FEI Number
- 3003999430
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- RODENBACHER CHAUSSEE 4
- City
- HANAU Hesse
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K182422
Owner / Operator
- Firm Name
- DENTSPLY SIRONA INC
- Operator Number
- 2511302
- Address
- 221 WEST PHILADELPHIA ST., SUITE 60W
- City
- York
- State
- PA
- Postal Code
- 17401
- Country
- US
US Agent
- Business Name
- DENTSPLY SIRONA INC
- Contact Name
- Dan Eagar
- Address
- 13320 Ballantyne Corp Pl
- City
- Charlotte
- State
- NC
- ZIP
- 28277
- Country
- US
- [email protected]
- Phone
- 704 4926977
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2019-05-23 |
| Powder, Porcelain | EIH | Class 2 | Dental | No | 2017-12-22 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2017-10-25 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2020-01-06 |
| Alloy, Gold-Based Noble Metal | EJT | Class 2 | Dental | No | 2003-10-20 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2018-12-18 |
| Dental Abutment Design Software For Dental Laboratory | PNP | Class 2 | Dental | No | 2023-03-23 |
| Alloy, Metal, Base | EJH | Class 2 | Dental | No | 2006-09-20 |
Proprietary Names
Celtra® Duo and Cerec® Zirconia Blocks & Materials Starter Kit
Shaded PMMA
VIPI BLOCK
PMMA Disks
Multilayer PMMA
Universal Body Stain
Universal Stain
Celtra Ceram
Universal Incisal Stain
Dentsply Sirona Universal Overglaze
CELTRA Duo
Dentsply Sirona Universal Incisal Stain
Dentsply Sirona Universal Body Stain
Universal Overglaze-High Flu
Dentsply Sirona Universal Stain & Overglaze Kit
Dentsply Sirona Universal Stain
Dentsply Sirona Universal Overglaze-High Flu
Universal Overglaze
Option
Duceragold Kiss
Cerec Essentials Materials Starter Kit
Duceram Kiss Porcelain
Duceram Plus Porcelain
LFC
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device