FDA Registration
Active
🇩🇪 Germany
Dentsply Implants Manufacturing GmbH
Reg #: 3013111692
·
FEI: 3013111692
·
Expires 2026
Products
8
Proprietary Names
6
Establishment Types
1
Classifications
8
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Registration Details
- Registration Name
- Dentsply Implants Manufacturing GmbH
- Registration Number
- 3013111692
- FEI Number
- 3013111692
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Rodenbacher Chaussee 4
- City
- Hanau Hesse
- Country
- DE
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 |
|---|---|---|---|---|---|
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2008-01-22 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2022-12-07 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2001-10-23 |
| Chisel, Osteotome, Surgical | EMM | Class 1 | Dental | No | 1984-08-15 |
| Instrument, Cutting, Operative | EKD | Class 1 | Dental | No | 2001-10-23 |
| Blade, Saw, General & Plastic Surgery, Surgical | GFA | Class 1 | General, Plastic Surgery | No | 2016-12-12 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2008-01-22 |
| Dental Abutment Design Software For Dental Laboratory | PNP | Class 2 | Dental | No | 2025-05-01 |
Proprietary Names
Implant
XiVe TG
Cercon Abutments
Ankylos Cercon Balance
Ankylos Temporary Abutment Balance
EsthetiCap
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)