FDA Registration
Active
🇩🇪 Germany
DENTSPLY DETREY GmbH
Reg #: 8010638
·
FEI: 3004724816
·
Expires 2026
Products
10
Proprietary Names
3
Establishment Types
3
Classifications
10
Registration Details
- Registration Name
- DENTSPLY DETREY GmbH
- Registration Number
- 8010638
- FEI Number
- 3004724816
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- DETREY STRASSE 1
- City
- KONSTANZ Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K780301
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 |
|---|---|---|---|---|---|
| Cement, Dental | EMA | Class 2 | Dental | No | 2008-01-16 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2018-11-28 |
| Agent, Tooth Bonding, Resin | KLE | Class 2 | Dental | No | 2015-12-28 |
| Resin, Root Canal Filling | KIF | Class 2 | Dental | No | 2025-02-20 |
| Dental Barriers And Sleeves | PEM | Class 2 | General, Plastic Surgery | No | 2016-06-17 |
| Preparer, Root Canal Endodontic | EKQ | Class 1 | Dental | No | 1977-12-28 |
| Activator, Ultraviolet, For Polymerization | EBZ | Class 2 | Dental | No | 2006-09-29 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2008-01-16 |
| Applicator, Resin | KXR | Class 1 | Dental | No | 1996-03-19 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2002-03-18 |
Proprietary Names
Tylok Cement
Adaptable Composite Resin
TPH Spectra ST
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device