FDA Registration
Active
🇩🇪 Germany
Sirona Dental Systems GmbH
Reg #: 9681851
·
FEI: 3002807009
·
Expires 2026
Products
11
Proprietary Names
6
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- Sirona Dental Systems GmbH
- Registration Number
- 9681851
- FEI Number
- 3002807009
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- FABRIKSTRASSE 31
- City
- Bensheim Hesse
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K073073
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 |
|---|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2008-02-13 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2008-01-22 |
| 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 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2022-03-11 |
| Handpiece, Contra- And Right-Angle Attachment, Dental | EGS | Class 1 | Dental | No | 2008-01-21 |
| Controller, Foot, Handpiece And Cord | EBW | Class 1 | Dental | No | 2012-11-19 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2001-10-23 |
| Plate, Bone | JEY | Class 2 | Dental | No | 2008-01-22 |
| Syringe, Periodontic, Endodontic, Irrigating | EIC | Class 1 | Dental | No | 1995-03-27 |
Proprietary Names
Ankylos Temporary Abutment Balance
EsthetiCap
XiVe TG
PrimeTaper
Implant
Dental Abutment/Implant
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility