Data / Medical devices / Germany / indigodental GmbH
indigodental GmbH: FDA-registered device maker in Pinneberg Schleswig-Holstein, Germany, 22 510(k) clearances
indigodental GmbH is registered with the FDA (registration 3006694515) in Pinneberg Schleswig-Holstein, Germany. It lists 13 device types. The FDA files 22 510(k) clearances under its listings, the newest dated September 30, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006694515
- Address
- Fahltskamp 5, Pinneberg Schleswig-Holstein, Germany, 25421
- Owner or operator
- indigodental GmbH (10023218)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- November 12, 2007
- Registered through
- 2026
- Brand names listed
- PROVISA CEM TEMP CEM CLR SYR, QuikGlaze, QuikGlaze Temp White, QuikGlaze XL
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Tooth Bonding, Resin | KLE | 2 | Exporter to the US | accessdata.fda.gov |
| Applicator, Resin | KXR | 1 | Exporter to the US | accessdata.fda.gov |
| Cement, Dental | EMA | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Coating, Filling Material, Resin | EBD | 2 | Exporter to the US | accessdata.fda.gov |
| Cord, Retraction | MVL | U | Manufacturer | accessdata.fda.gov |
| Crown And Bridge, Temporary, Resin | EBG | 2 | Exporter to the US | accessdata.fda.gov |
| Handle, Instrument, Dental | EJB | 1 | Exporter to the US | accessdata.fda.gov |
| Material, Impression | ELW | 2 | Exporter to the US | accessdata.fda.gov |
| Material, Impression Tray, Resin | EBH | 1 | Exporter to the US | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 2 | Exporter to the US | accessdata.fda.gov |
| Sealant, Pit And Fissure, And Conditioner | EBC | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Syringe, Restorative And Impression Material | EID | 1 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| September 30, 2016 | K160443 | TempoCem Clear | EMA | Substantially Equivalent | Dmg USA, Inc. | accessdata.fda.gov |
| February 25, 2014 | K130580 | RETRACTION PASTE | MVL | Substantially Equivalent | Dmg USA, Inc. | accessdata.fda.gov |
| July 11, 2013 | K131248 | ETCH GEL | KLE | Substantially Equivalent | Dmg America, LLC | accessdata.fda.gov |
| November 17, 2010 | K102603 | SA FLOWABLE ADHESIVE | EBF | Substantially Equivalent | Dmg USA, Inc. | accessdata.fda.gov |
| September 28, 2010 | K101710 | LUXATEMP ULTRA /STAR | EBG | Substantially Equivalent | Dmg USA, Inc. | accessdata.fda.gov |
| February 12, 2010 | K093338 | SELF ADHESIVE COMPOSITE LUTING CEMENT | EMA | Substantially Equivalent | Dmg USA, Inc. | accessdata.fda.gov |
| May 30, 2008 | K080480 | NANOCOMPOSITE RESTORATIVE KIT | EBF | Substantially Equivalent | Dmg USA, Inc. | accessdata.fda.gov |
| March 20, 2007 | K063444 | TOTAL ETCH BONDING AGENT | KLE | Substantially Equivalent | Dmg USA, Inc. | accessdata.fda.gov |
| January 16, 2004 | K033227 | LUXAFORM PLUS | EBG | Substantially Equivalent | Dmg USA, Inc. | accessdata.fda.gov |
| January 17, 2003 | K023649 | VITIQUE SYSTEM | EMA | Substantially Equivalent | Dmg USA, Inc. | accessdata.fda.gov |
| January 24, 2002 | K013674 | LUXATEMP/LUXATEMP SOLAR/INSTATEMP | EBG | Substantially Equivalent | Dmg USA, Inc. | accessdata.fda.gov |
| October 12, 2001 | K013179 | LUXAGLAZE | EBD | Substantially Equivalent | Dmg USA, Inc. | accessdata.fda.gov |
| August 23, 2001 | K012307 | LUXACORE/LUXACORE DUAL | EBF | Substantially Equivalent | Dmg USA, Inc. | accessdata.fda.gov |
| June 18, 2001 | K011211 | FLOWABLE COMPOSITE/ ECUFLOW/ LUXAFLOW | EBF | Substantially Equivalent | Dmg USA, Inc. | accessdata.fda.gov |
| September 22, 1999 | K992609 | HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400 | EBI | Substantially Equivalent | Kay See Dental Mfg. Co. | accessdata.fda.gov |
| January 8, 1999 | K984341 | STERNVANTAGE VARNISH LC, MODEL 221001 | EBI | Substantially Equivalent | Sterngold/Implamed | accessdata.fda.gov |
| October 22, 1998 | K982692 | STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC | EBF | Substantially Equivalent | Sterngold/Implamed | accessdata.fda.gov |
| May 19, 1998 | K980018 | CRISTOBAL | EBF | Substantially Equivalent | Newave Medical, Inc. | accessdata.fda.gov |
| June 3, 1997 | K970774 | TEMPOCEM NE (MULTIPLE) | EMA | Substantially Equivalent | Foremost Dental Mfg., Inc. | accessdata.fda.gov |
| March 8, 1996 | K954867 | IONOSIT SEAL | EBC | Substantially Equivalent | Foremost Dental Mfg., Inc. | accessdata.fda.gov |
| February 13, 1989 | K890464 | ZENITH 40% PHOSPHORIC ACID GEL | EBC | Substantially Equivalent | Foremost Dental Mfg., Inc. | accessdata.fda.gov |
| April 14, 1981 | K810825 | POLYVINYL SILICONE IMPRESSION MATERIAL | ELW | Substantially Equivalent | Dental-Material Gesellschaft | accessdata.fda.gov |
Compare with other makers
- All makers of Agent, Tooth Bonding, Resin
- All makers of Cement, Dental
- All makers of Handle, Instrument, Dental
- All makers of Coating, Filling Material, Resin
- All makers of Resin, Denture, Relining, Repairing, Rebasing
- All makers of Material, Tooth Shade, Resin
Updated September 30, 2016. 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.