FDA Registration
Active
🇩🇪 Germany
BREDENT GMBH & CO.KG
Reg #: 1000303432
·
FEI: 1000303432
·
Expires 2026
Products
13
Proprietary Names
2
Establishment Types
1
Classifications
13
Registration Details
- Registration Name
- BREDENT GMBH & CO.KG
- Registration Number
- 1000303432
- FEI Number
- 1000303432
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- WEISSENHORNERSTR. 2
- City
- SENDEN Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K052780
Owner / Operator
- Firm Name
- bredent GmbH & Co. KG
- Operator Number
- 9027334
- Address
- Weissenhornerstrasse 2, --
- City
- Senden
- State
- Bavaria
- Postal Code
- 89250
- Country
- DE
US Agent
- Business Name
- MEDAGENT Inc.
- Contact Name
- Franz Menean
- Address
- 264 Lafayette Rd Ste 7
- City
- Portsmouth
- State
- NH
- ZIP
- 03801
- Country
- US
- [email protected]
- Phone
- 603 5702039
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2008-09-14 |
| Denture, Plastic, Teeth | ELM | Class 2 | Dental | No | 2010-09-21 |
| Protector, Silicate | EFX | Class 1 | Dental | No | 2023-09-05 |
| Alloy, Metal, Base | EJH | Class 2 | Dental | No | 2006-02-17 |
| Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer | KOL | Class 1 | Dental | No | 2010-05-26 |
| Tray, Impression, Preformed | EHY | Class 1 | Dental | No | 2004-06-11 |
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2016-09-09 |
| Pin, Retentive And Splinting, And Accessory Instruments | EBL | Class 1 | Dental | No | 2004-06-11 |
| Attachment, Precision, All | EGG | Class 1 | Dental | No | 1996-08-07 |
| Denture Preformed (Partially Prefabricated Denture) | EKO | Class 2 | Dental | No | 2023-09-05 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2004-06-11 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2004-06-11 |
| Coating, Filling Material, Resin | EBD | Class 2 | Dental | No | 2025-01-29 |
Proprietary Names
visio.lign color
visio.lign shield
Establishment Types
Manufacture Medical Device