Data / Medical devices / Germany / Bredent GMBH & Co.kg
Bredent GMBH & Co.kg: FDA-registered device maker in SENDEN Bavaria, Germany, 5 510(k) clearances
Bredent GMBH & Co.kg is registered with the FDA (registration 1000303432) in SENDEN Bavaria, Germany. It lists 13 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 12, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1000303432
- Address
- Weissenhornerstr. 2, SENDEN Bavaria, Germany, 89250
- Owner or operator
- bredent GmbH & Co. KG (9027334)
- Roles
- Manufacturer
- First device listed
- August 7, 1996
- Registered through
- 2026
- Brand names listed
- visio.lign color, visio.lign shield
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer | KOL | 1 | Manufacturer | accessdata.fda.gov |
| Alloy, Metal, Base | EJH | 2 | Manufacturer | accessdata.fda.gov |
| Attachment, Precision, All | EGG | 1 | Manufacturer | accessdata.fda.gov |
| Coating, Filling Material, Resin | EBD | 2 | Manufacturer | accessdata.fda.gov |
| Denture Preformed (Partially Prefabricated Denture) | EKO | 2 | Manufacturer | accessdata.fda.gov |
| Denture, Plastic, Teeth | ELM | 2 | Manufacturer | accessdata.fda.gov |
| Drill, Dental, Intraoral | DZA | 1 | Manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Manufacturer | accessdata.fda.gov |
| Pin, Retentive And Splinting, And Accessory Instruments | EBL | 1 | Manufacturer | accessdata.fda.gov |
| Protector, Silicate | EFX | 1 | Manufacturer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Manufacturer | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Manufacturer | accessdata.fda.gov |
| Wax, Dental, Intraoral | EGD | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 12, 2024 | K240735 | visio.lign color, visio.lign shield | EBD | Substantially Equivalent | Bredent GmbH & Co. KG | accessdata.fda.gov |
| July 21, 2016 | K152113 | BioHPP - breCAM.BioHPP | EBF | Substantially Equivalent | Bredent GmbH & Co. KG | accessdata.fda.gov |
| September 14, 2010 | K101064 | BREDENT NOVO.LIGN A/ BREDENT NOVO.LIGN P | ELM | Substantially Equivalent | Bredent GmbH & Co. KG | accessdata.fda.gov |
| December 21, 2005 | K052780 | DENTAPLAST HOT, MODEL 16-XXX | EBI | Substantially Equivalent | Bredent-Products For the Dental Technician Laborat | accessdata.fda.gov |
| December 20, 2005 | K052779 | BRECOMP | EBF | Substantially Equivalent | Bredent-Products For the Dental Technician Laborat | accessdata.fda.gov |
Compare with other makers
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Material, Tooth Shade, Resin
- All makers of Tray, Impression, Preformed
- All makers of Denture, Plastic, Teeth
- All makers of Attachment, Precision, All
- All makers of Wax, Dental, Intraoral
Updated December 12, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.