Manufacturer registered with FDA
DMG Chemisch-Pharmazeutische Fabrik GmbH
HAMBURG, Germany. Lists 20 dental device types with FDA across 1 registered establishment, and holds 4 510(k) clearances as applicant.
- Device types listed
- 20
- Brands and models
- 280
- 510(k) clearances
- 41994–2022
- Markets registered in
- 13763 registrations outside the US
- Establishments
- 1Germany
510(k) clearances per year, 1990–2026
Registered in 13 markets
Where regulators' registries name DMG Chemisch-Pharmazeutische Fabrik GmbH as the manufacturer or the registration holder of a device.
RegisteredHome: GermanyOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | DMG Chemisch-Pharmazeutische Fabrik GmbH | 4 clearances | 1994–2022 | Below |
| Colombia | INVIMA | Registration holder | DMG CHEMISCH-PHARMAZEUTISCHE FABRIK GMBHDMG CHEMISCH - PHARMAZEUTISCHE FABRIK GMBH · DMG CHEMISCH-PHARMAZEUTISCHE, FABRIK GMBH | 427 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | DMG CHEMISCH-PHARMAZEUTISCHE FABRIK GMBH | 103 | 2004–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | DMG Chemisch-Pharmazeutische Fabrik GmbHDMG Chemisch Pharmazeutische Fabrik GmbH · DMG CHEMISCH-PHARMAZEUTISCHE FABRIK GMBH · +1 | 56 | 1999–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | DMG Chemisch Pharmazeutische Fabrik GmbH | 33 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Dmg Chemisch-Pharmazeutische Fabrik GmbH | 30 | 2015–2026 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | DMG Chemisch Pharmazeutische Fabrik GmbH | 26 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | DMG Chemisch-Pharmazeutische Fabrik GmbH | 24 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | DMG Chemisch-Pharmazeutische Fabrik GmbH | 22 | 2022–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | DMG CHEMISCH-PHARMAZEUTISCHE FABRIK GMBH | 21 | 2005–2026 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | DMG CHEMISCH-PHARMAZEUTISCHE FABRIK GMBHDMG – CHEMISCH-PHARMAZEUTISCHE FABRIK GMBH | 10 | 2018–2026 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | DMG CHEMISCH-PHARMAZEUTISCHE FABRIK GmbHDMG CHEMISCH - PHARMAZEUTISCHE FABRIK GmbH | 6 | 2019–2026 | Pure Global AI |
| Philippines | FDA Philippines | Manufacturer | DMG Chemisch-Pharmazeutische Fabrik GmbH | 5 | 2025–2025 | 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 DMG Chemisch-Pharmazeutische Fabrik 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 |
|---|---|---|---|---|
| Dental CementEMA · Class 2 | Dental cements | Maker | Contax Intro + ActivatorContax Intro + Activator USAContax-Activator RefillContax-Bond RefillContax-Primer RefillContax-Primer Refill USAPerma Cem 1+40PermaCem 2 9g A2PermaCem 2 9g A2 USAPermaCem 2 9g A3 Opaque 44 morePermaCem 2 9g A3 Opaque USAPermaCem 2 9g TransparentPermaCem 2 9g TransparentUSAPermaCem AM Dual RefillPermaCem Smartmix Dual USASilane 2-Komponenten USATempoCem AM NE Intro USATempoCem AM NE Refill 1+40 USATEMPOCEM NE SMARTMIX USATempoCemID SmartmixVitique Basis A1Vitique Basis A2,5Vitique Basis A4Vitique Basis B1Vitique Basis BLVitique Basis PinkVitique Basis TransparentVitique Basis WhiteVitique Catalyst High ViscosityVitique Catalyst Low ViscosityVitique Cement A1Vitique Cement A2,5Vitique Cement A4Vitique Cement B1Vitique Cement BLVitique Cement PinkVitique Cement TransparentVitique Cement WhiteVitique Intro Kit USAVitique Silane 2-KomponentenVitique Starter KitVitique Try In A1Vitique Try In A2,5Vitique Try In A4Vitique Try In B1Vitique Try In BLVitique Try In Catalyst ShadeVitique Try In PinkVitique Try In TransparentVitique Try In WhiteVitique Try In White USAVitique Veneer Accessory KitVitique Veneer Cementation KitVitique Veneer System | 2007 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | Constic A1Constic A2Constic A3Constic A3,5Constic B1Constic Opak-WeissConstic Opaque-White USAEcosite Bulk 16x0.25 contr.USAEcosite Bulk 16x0.25 light USAEcosite Bulk 16x0.25 univ. USA 31 moreEcosite Bulk Fill 4g contr.USAEcosite Bulk Fill 4g light USAEcosite Bulk Fill 4g univ. USAEcosite Bulk Fill Set 0.25g USAEcosite Bulk Fill Set 4g USAEcosite One 16x0.25 g USAEcosite One 4 g USAEcosite One Sample USALuxaCore Z-Dual AM A3 USALuxaCore Z-Dual AM Blue USALuxaCore Z-Dual AM LO USALuxaCore Z-Dual Automix A3LuxaCore Z-Dual Automix blueLuxaCore Z-Dual Automix light opaquLuxaCore Z-Dual SM A3 USALuxaCore Z-Dual SM blau USALuxaCore Z-Dual SM LO USALuxaCore Z-Dual Smartmix A3LuxaCore Z-Dual Smartmix blueLuxaCore Z-Dual Smartmix light opaqLuxaflow A20 RefillLuxaflow Floures. Intro USALuxaflow Fluores. A10 RefillLuxaflow Fluores. A20 RefillLuxaflow Fluores. A3 Refill USLuxaflow Fluores. A35 RefillLuxaflow Fluores. E-Light Ref.Luxaflow Refill A10 USALuxaflow Refill A35Luxaflow Refill B1 Extra LightLuxaFlow Ultra BL | 2007 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Maker | Kit LX-Plus A2+Ionosit BLKit LX-Ultra A2+Ionosit BLLuxatemp AM Plus 1+15 A1 USALuxatemp AM Plus 1+15 A2 IntroLuxatemp AM Plus 1+15 A2 USALuxatemp AM Plus 1+15 A35 USALuxatemp AM Plus 1+15 B1 USALuxatemp AM Plus 1+15 BL USALuxatemp AM Plus 5+75 A10 USALuxatemp AM Plus 5+75 A20 USA 24 moreLuxatemp AM Plus A35 5+75Luxatemp AM Solar Plus 1+15 A2Luxatemp DKS 1+15 A10 LUMI USALuxatemp DKS 1+15 A20 LUMI USALuxatemp DKS 1+15 A35 LUMI USALuxatemp DKS 1+15 B10 LUMI USALuxatemp DKS 1+15 BL LUMI USALuxatemp Fluorescence 10ml A2Luxatemp Fluorescence 10ml B1Luxatemp Fluorescence 10ml BLLuxatemp Fluorescence A3 ReUSALuxatemp Fluoro 10ml A2 USALuxatemp Fluoro 10ml B1 USALuxatemp Fluoro 10ml BL USALuxatemp-Ultra AM A1 USALuxatemp-Ultra AM A2 USALuxatemp-Ultra AM A3 USALuxatemp-Ultra AM A3,5 USALuxatemp-Ultra AM B1 USALuxatemp-Ultra AM BL USALuxatemp-Ultra SM A2 USALuxatemp-Ultra SM B1 USALuxatemp-Ultra SM BL USATemp Tabs Natural | 2007 |
| Impression MaterialELW · Class 2 | Impression materials | Maker | Honigum AM Heavy Fast USAHonigum AM Heavy USAHonigum AM Light 4x25 USAHonigum AM Light Fast 4x 25 mlHonigum AM Mono 50ml USAHonigum Light AM 2x50 USAHonigum Light QuadFast2x50 USAHonigum Mono Quad Fast 4x50 mlHonigum MS Heavy 1x USAHonigum MS Heavy Fast 1+10 USA 34 moreHonigum MS Mono 1+10 USAHonigum MS Putty 1+10 USAHonigum Pro Heavy 1*380+10Honigum Pro Heavy AM USAHonigum Pro Heavy Fast 1MSHonigum Pro Heavy Fast 1MS USAHonigum Pro Heavy Fast AM USAHonigum Pro Heavy MS 1x USAHonigum Pro Light 2*50 mlHonigum Pro Light 2x50ml USAHonigum Pro Light AM 4x25 USAHonigum Pro Light Fast 4x25 USHonigum Pro Light Fast AM 4x25Honigum Pro Mono 2*50 ml+4Honigum Pro Mono AM 50ml USAHonigum Pro Mono Fast 50 mlHonigum Pro Mono MS 1xHonigum Pro Mono MS 1x USAHonigum Pro Putty MS 1xHonigum Pro Putty MS 1x USAHonigum Pro Rigid Fast 50 mlHonigum Pro Trial Kit FastHonigum Pro Trial Kit RegHonigum Pro Trial Kit USAHonigum ProLightQuad Fast 2x50Honigum ProLightQuadFast2x50USHonigum Rigid X-tra Fast4x50mlHonigum Trial Kit USAImpression Material Rigid FastLUXABITE AUTOMIX NPA USAMono 1*380 ml+10O-Bite 4x50ml+15 USAStatus Blue 8x50ml Bulk for TubStatus Blue MS 1+10 USA | 2007 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Maker | Constic A1Constic A2Constic A3Constic A3,5Constic B1Constic Opak-WeissConstic Opaque-White USAEcusitEtchUSA Refill 50MT0,1mlIcon approximal 2 units USAIcon approximal 7 units USA 9 moreIcon Capillary TipsIcon Proximal TipsIcon vestibular 2 units USAIcon vestibular 7 units USAIcon Vestibular TipsIcon WedgesIcon-Etch Refill USAVitique Veneer Accessory KitVitique Veneer System | 2007 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | DMG Etching Gel JumboDMG Etching Gel Medium ViscosiLuxaBond Pre-Bond RefillLuxaBond Total Etch USATECO Introkit SilvR doseTECO Introkit SilvR dose USAVitique Silane 2-KomponentenVitique Veneer Accessory KitVitique Veneer System | 2007 |
| Resin Filling Material CoatingEBD · Class 2 | — | Maker | Ionosit Baseliner 10x 0.3g USAIonosit Baseliner 2x 1.5g USAIonosit Microspand 10x 0,3gIonosit Microspand 1x 0,3gKit LX-Plus A2+Ionosit BLKit LX-Ultra A2+Ionosit BLLuxaglaze 5 mlSample Baseliner 1x 0.3g USA | 2007 |
| Rebasing Repairing Relining Denture ResinEBI · Class 2 | Denture resins & teeth | Maker | QuikGlazeQuikGlaze XLSilagum AM Comfort Primer RefiSilagum AM Comfort Varnish RefSilagum Comfort 1x50ml + 12 | 2012 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | Tray Adhesive 1x 10ml USA | 2007 |
| Ac-Powered Dental AmalgamatorEFD · Class 1 | — | Maker | MixStar eMotion 115 V USAMixStar-eMotionMixStar-Tips 50x USAMK Status Blue 25 ST USA | 2007 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Icon tooth-brush | 2012 |
| X-Ray Film HolderEGZ · Class 1 | — | Maker | Icon X-ray holder Intro KitIcon X-ray holder Refill Size 1Icon X-ray holder Refill Size 2Icon X-ray holder Size 1 20+2Icon X-ray holder Size 2 20+2X-Ray film holder - Dixi B1X-Ray film holder - Dixi B2 | 2010 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | Automix-Dispenser 50 1:1 USAAutomix-Dispenser Type 25 1:1Automix-Tips Blue 1:1 50 Stk UAutomix-Tips Green 1:1 50x USAAutomix-Tips Yellow 1:1 35x +Constic AccessoriesConstic Accessories USAEndo-Smartmix-Tips 20xIntraoral-Tips Transp.50x USALUXABITE AM 25 MK USA 16 moreLuxaflow Mischkanülen USALuxatemp AM Zub Dispenser USALuxatemp AM Zub PlungerLuxatemp AM Zub Plunger USAMixstar-Tips blue 50x USAProkb AM Zub 25 MK-Mbx USASafetip Dispenser ProSmartmix-Tips 4:1 50STSmartmix-Tips 4:1 50ST USASmartmix-Tips 4:1 USASmartmix-Tips 50x USASmartmix-Tips Combi USASmartmix-Tips Green-Blue 25xUSTüte mit 50 MK MB 5.4-12D USAVitique Conturat. Tips 100 USAVitique Conturation Tips 100 | 2007 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | DMG MiniDamDMG MiniDam 100xDMG MiniDam 20x USADMG MiniDam Sample | 2015 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | LuxaPost Bohrer 1,25LuxaPost Bohrer 1,375LuxaPost Bohrer 1,5LuxaPost PS Intro USA | 2011 |
| Root Canal PostELR · Class 1 | Root canal filling materials | Maker | LuxaPost PS Intro USALuxaPost PS Refill 1.25 USALuxaPost PS Refill 1.375 USALuxaPost PS Refill 1.5 USA | 2007 |
| Zinc Oxide EugenolEMB · Class 1 | Dental cements | Maker | TempoCem AM Refill 1+40 USATempoCem-Smartmix USA | 2011 |
| Resin ApplicatorKXR · Class 1 | — | Maker | Constic AccessoriesEcu-Pen Microtip ApplicatorEndobrushes 25 St USAEndobrushes Black 25 St USAMicrobrushes Weiss 25 StkMicrobrushes X Red 25 Stck.Microbrushes X SCHW 25 Stck. | 2007 |
| Dental Stain EraserMAU · Class 1 | — | Maker | Flairesse Bleaching Gel CP 10% RefillFlairesse Bleaching Gel CP 10% Starter KitFlairesse Bleaching Gel CP 16% RefillFlairesse Bleaching Gel CP 16% Starter KitFlairesse Bleaching Gel CP 5% RefillFlairesse Bleaching Gel CP 5% Starter Kit | 2026 |
| Resin Long-Term Temporary Crown and BridgePOW · Class 2 | — | Maker | — | 2019 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names DMG Chemisch-Pharmazeutische Fabrik GmbH as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 1 Jun 2022 | K213201 | DeltaFil, DeltaFil Conditioner | EMA Dental Cement |
| 29 May 2019 | K183337 | LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2 | EBG Resin Temporary Crown and Bridge |
| 17 May 1999 | K991172 | IONOSIT BOND | EMA Dental Cement |
| 29 Apr 1994 | K924830 | LUXATEMP AUTOMIX | EBG Resin Temporary Crown and Bridge |
Some of these clearances are listed with FDA today by another company: Sterngold (1).
Also lists devices cleared under other names
DMG Chemisch-Pharmazeutische Fabrik 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. (19), Foremost Dental Mfg., Inc. (3), Sterngold/Implamed (2), DMG America, L.L.C. (1), Kay See Dental Mfg. Co. (1), Dental-Material Gesellschaft (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 31 Jan 2018 | K171772 | Ecosite Bulk Fill | Dmg USA, Inc. | EBF Resin Tooth Shade Material |
| 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 |
| 10 Jun 2011 | K110759 | TEMPOCEM | Dmg USA, Inc. | EMB Zinc Oxide Eugenol |
| 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 |
| 26 Mar 2010 | K100062 | INFILTRATION KIT | Dmg USA, Inc. | EBC Pit and Fissure Sealant and Conditioner |
| 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 |
| 22 Oct 2001 | K013237 | STATUSBLUE | Dmg USA, Inc. | ELW Impression Material |
| 17 Oct 2001 | K013236 | LUXABITE | Dmg USA, Inc. | ELW Impression Material |
| 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 |
| 23 Aug 2001 | K012316 | PERMACEM / PERMACEM DUAL | Dmg USA, Inc. | EMA Dental Cement |
| 18 Jun 2001 | K011211 | FLOWABLE COMPOSITE/ ECUFLOW/ LUXAFLOW | Dmg USA, Inc. | EBF Resin Tooth Shade Material |
| 11 Apr 2000 | K000878 | HONIGUM | Dmg USA, Inc. | ELW Impression 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 |
| 9 Oct 1998 | K982895 | STERNOMEGA COMPOMER CEMENT | Sterngold/Implamed | EMA Dental Cement |
| 3 Jun 1997 | K970774 | TEMPOCEM NE (MULTIPLE) | Foremost Dental Mfg., Inc. | EMA Dental Cement |
| 21 Jan 1994 | K935689 | IONOSIT BASE LINER | Foremost Dental Mfg., Inc. | EBD Resin Filling Material Coating |
| 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 |
|---|---|---|
| DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBHFDA reg. 8044164 | HAMBURG, Germany | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9005969). 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.