Data / Medical devices / Germany / Degudent GMBH
Degudent GMBH: FDA-registered device maker in HANAU Hesse, Germany, 18 510(k) clearances
Degudent GMBH is registered with the FDA (registration 9681199) in HANAU Hesse, Germany. It lists 8 device types. The FDA files 18 510(k) clearances under its listings, the newest dated October 24, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9681199
- FEI number
- 3003999430
- Address
- Rodenbacher Chaussee 4, HANAU Hesse, Germany, 63457
- Owner or operator
- DENTSPLY SIRONA INC (2511302)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer, Specification developer
- First device listed
- October 20, 2003
- Registered through
- 2026
- Brand names listed
- CELTRA Duo, Celtra Ceram, Celtra® Duo and Cerec® Zirconia Blocks & Materials Starter Kit, Cerec Essentials Materials Starter Kit, Dentsply Sirona Universal Body Stain, Dentsply Sirona Universal Incisal Stain, Dentsply Sirona Universal Overglaze, Dentsply Sirona Universal Overglaze-High Flu and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Contract manufacturer | accessdata.fda.gov |
| Alloy, Gold-Based Noble Metal | EJT | 2 | Manufacturer | accessdata.fda.gov |
| Alloy, Metal, Base | EJH | 2 | Manufacturer | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Manufacturer | accessdata.fda.gov |
| Dental Abutment Design Software For Dental Laboratory | PNP | 2 | Manufacturer | accessdata.fda.gov |
| Powder, Porcelain | EIH | 2 | Exporter to the US, Manufacturer, Specification developer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | 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 |
|---|---|---|---|---|---|---|
| October 24, 2024 | K242462 | CEREC Cercon 4D CAD/CAM Blocks | EIH | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| August 28, 2024 | K241557 | Cercon® yo ML | EIH | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| May 7, 2024 | K234018 | CEREC Cercon 4D Abutment Blocks, CEREC Cercon 4D Abutment System | NHA | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| March 22, 2023 | K221402 | CEREC Tessera Abutment Block, CEREC Tessera Abutment System | NHA | Substantially Equivalent | Dentsply Sirona, Inc. | accessdata.fda.gov |
| January 20, 2021 | K202629 | Dentsply Sirona Universal Spray Glazes | EIH | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| December 18, 2018 | K182422 | Lucitone Denture Base Materials | EBI | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| August 1, 2018 | K180703 | VITA YZ ST and VITA YZ XT | EIH | Substantially Equivalent | Vita Zahnfabrik H.Rauter GmbH Co. | accessdata.fda.gov |
| February 24, 2017 | K162888 | Cercon | EIH | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| August 12, 2016 | K161269 | CELTRA Press | EIH | Substantially Equivalent | Dentsply Sirona | accessdata.fda.gov |
| February 22, 2013 | K123615 | IRIS - HIGH STRENGTH GLASS CERAMIC | EIH | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| February 1, 2013 | K123545 | INCORIS TZI | EIH | Substantially Equivalent | Sirona Dental Systems GmbH | accessdata.fda.gov |
| November 9, 2011 | K112152 | CERCON HT | EIH | Substantially Equivalent | Dentsply International, Inc. | accessdata.fda.gov |
| December 16, 2010 | K102341 | VIPI BLOCK | EBG | Substantially Equivalent | Vipi Industria,Comercio,Exportacao E Importacao DE | accessdata.fda.gov |
| June 24, 2005 | K051462 | MODIFICATION TO: CERCON BASE | EIH | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| March 18, 2004 | K040421 | DUCERAGOLD PORCELAINS | EIH | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| March 18, 2004 | K040420 | DUCERAM PLUS CERAMIC SYSTEM | EIH | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| September 6, 2002 | K022796 | CERCON CERAM S PORCELAIN | EIH | Substantially Equivalent | Dentsply Intl. | accessdata.fda.gov |
| June 22, 1992 | K921479 | DUCERATIN/DUCERAM LFC DENTAL PORCELAIN | EIH | Substantially Equivalent | Degussa AG | accessdata.fda.gov |
Compare with other makers
- All makers of Powder, Porcelain
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Alloy, Metal, Base
- All makers of Alloy, Gold-Based Noble Metal
- All makers of Crown And Bridge, Temporary, Resin
- All makers of Abutment, Implant, Dental, Endosseous
Updated October 24, 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.