Manufacturer registered with FDA
indigodental GmbH
Pinneberg, Germany. Lists 12 dental device types with FDA across 1 registered establishment.
- Device types listed
- 12
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 411 registrations outside the US
- Establishments
- 1Germany
Registered in 4 markets
Where regulators' registries name indigodental GmbH as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | indigodental GmbH | 12 device types | — | Below |
| Brazil | ANVISA | Manufacturer | INDIGODENTAL GMBH. | 8 | 2018–2018 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Indigodental GmbH | 2 | 1998–2008 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | indigodental GmbH | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What indigodental GmbH currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | — | 2007 |
| Dental CementEMA · Class 2 | Dental cements | Maker | PROVISA CEM TEMP CEM CLR SYR | 2008 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Maker | — | 2008 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Lister | — | 2007 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Lister | — | 2010 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Lister | — | 2008 |
| Resin Filling Material CoatingEBD · Class 2 | — | Lister | QuikGlazeQuikGlaze Temp WhiteQuikGlaze XL | 2018 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Lister | — | 2008 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Lister | — | 2015 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Lister | — | 2015 |
| Impression MaterialELW · Class 2 | Impression materials | Lister | — | 2008 |
| Resin ApplicatorKXR · Class 1 | — | Lister | — | 2015 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
indigodental GmbH lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Dmg USA, Inc. (12), Foremost Dental Mfg., Inc. (3), Sterngold/Implamed (2), DMG America, L.L.C. (1), Kay See Dental Mfg. Co. (1), Newave Medical, Inc. (1), Dental-Material Gesellschaft (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 30 Sep 2016 | K160443 | TempoCem Clear | Dmg USA, Inc. | EMA Dental Cement |
| 11 Jul 2013 | K131248 | ETCH GEL | DMG America, L.L.C. | KLE Resin Tooth Bonding Agent |
| 17 Nov 2010 | K102603 | SA FLOWABLE ADHESIVE | Dmg USA, Inc. | EBF Resin Tooth Shade Material |
| 28 Sep 2010 | K101710 | LUXATEMP ULTRA /STAR | Dmg USA, Inc. | EBG Resin Temporary Crown and Bridge |
| 12 Feb 2010 | K093338 | SELF ADHESIVE COMPOSITE LUTING CEMENT | Dmg USA, Inc. | EMA Dental Cement |
| 30 May 2008 | K080480 | NANOCOMPOSITE RESTORATIVE KIT | Dmg USA, Inc. | EBF Resin Tooth Shade Material |
| 20 Mar 2007 | K063444 | TOTAL ETCH BONDING AGENT | Dmg USA, Inc. | KLE Resin Tooth Bonding Agent |
| 16 Jan 2004 | K033227 | LUXAFORM PLUS | Dmg USA, Inc. | EBG Resin Temporary Crown and Bridge |
| 17 Jan 2003 | K023649 | VITIQUE SYSTEM | Dmg USA, Inc. | EMA Dental Cement |
| 24 Jan 2002 | K013674 | LUXATEMP/LUXATEMP SOLAR/INSTATEMP | Dmg USA, Inc. | EBG Resin Temporary Crown and Bridge |
| 12 Oct 2001 | K013179 | LUXAGLAZE | Dmg USA, Inc. | EBD Resin Filling Material Coating |
| 23 Aug 2001 | K012307 | LUXACORE/LUXACORE DUAL | Dmg USA, Inc. | EBF Resin Tooth Shade Material |
| 18 Jun 2001 | K011211 | FLOWABLE COMPOSITE/ ECUFLOW/ LUXAFLOW | Dmg USA, Inc. | EBF Resin Tooth Shade Material |
| 22 Sep 1999 | K992609 | HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400 | Kay See Dental Mfg. Co. | EBI Rebasing Repairing Relining Denture Resin |
| 8 Jan 1999 | K984341 | STERNVANTAGE VARNISH LC, MODEL 221001 | Sterngold/Implamed | EBI Rebasing Repairing Relining Denture Resin |
| 22 Oct 1998 | K982692 | STERNOMEGA BONDING AGENT, STERNOMEGA COMPOSITE LC, STERNOMEGA COMPOMER LC | Sterngold/Implamed | EBF Resin Tooth Shade Material |
| 19 May 1998 | K980018 | CRISTOBAL | Newave Medical, Inc. | EBF Resin Tooth Shade Material |
| 3 Jun 1997 | K970774 | TEMPOCEM NE (MULTIPLE) | Foremost Dental Mfg., Inc. | EMA Dental Cement |
| 8 Mar 1996 | K954867 | IONOSIT SEAL | Foremost Dental Mfg., Inc. | EBC Pit and Fissure Sealant and Conditioner |
| 13 Feb 1989 | K890464 | ZENITH 40% PHOSPHORIC ACID GEL | Foremost Dental Mfg., Inc. | EBC Pit and Fissure Sealant and Conditioner |
| 14 Apr 1981 | K810825 | POLYVINYL SILICONE IMPRESSION MATERIAL | Dental-Material Gesellschaft | ELW Impression Material |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| indigodental GmbHFDA reg. 3006694515 | Pinneberg Schleswig-Holstein, Germany | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10023218). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.