BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH

    Reg #: 8044164 · FEI: 3004150030 · Expires 2026
    View on FDA
    Products
    19
    Proprietary Names
    258
    Establishment Types
    1
    Classifications
    19

    Registration Details

    Registration Name
    DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH
    Registration Number
    8044164
    FEI Number
    3004150030
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    ELBGAUSTRASSE 248
    City
    HAMBURG
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K890464

    Owner / Operator

    Firm Name
    DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH
    Operator Number
    9005969
    Address
    ELBGAUSTRASSE 248, --
    City
    HAMBURG
    State
    DE-HH
    Postal Code
    D-22547
    Country
    DE

    US Agent

    Business Name
    Delphi Medical Device Consulting, Inc.
    Contact Name
    Pamela Papineau
    Address
    5 WHITCOMB AVENUE
    City
    Ayer
    State
    MA
    ZIP
    01432
    Country
    US
    Email
    [email protected]
    Phone
    978 7588322

    Products

    Device Name Product Code
    Bur, Dental EJL
    Sealant, Pit And Fissure, And Conditioner EBC
    Cement, Dental EMA
    Dam, Rubber EIE
    Crown And Bridge, Temporary, Resin EBG
    Syringe, Restorative And Impression Material EID
    Coating, Filling Material, Resin EBD
    Material, Tooth Shade, Resin EBF
    Zinc Oxide Eugenol EMB
    Agent, Tooth Bonding, Resin KLE
    Amalgamator, Dental, Ac-Powered EFD
    Material, Impression ELW
    Toothbrush, Manual EFW
    Holder, Film, X-Ray EGZ
    Material, Impression Tray, Resin EBH
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Crown And Bridge, Long-Term Temporary, Resin POW
    Applicator, Resin KXR
    Post, Root Canal ELR

    Proprietary Names

    LuxaPost Bohrer 1,375 LuxaPost Bohrer 1,5 LuxaPost Bohrer 1,25 LuxaPost PS Intro USA EcusitEtchUSA Refill 50MT0,1ml Vitique Veneer Accessory Kit Vitique Veneer System PermaCem 2 9g Transparent PermaCem 2 9g A3 Opaque PermaCem 2 9g A2 PermaCem 2 9g A3 Opaque USA PermaCem 2 9g TransparentUSA PermaCem 2 9g A2 USA DMG MiniDam Sample DMG MiniDam 100x DMG MiniDam DMG MiniDam 20x USA Luxatemp Fluoro 10ml BL USA Luxatemp DKS 1+15 A35 LUMI USA Luxatemp Fluoro 10ml B1 USA Luxatemp DKS 1+15 B10 LUMI USA Luxatemp AM Plus 1+15 A1 USA Luxatemp DKS 1+15 BL LUMI USA Luxatemp AM Plus 1+15 A35 USA Luxatemp AM Plus 1+15 A2 Intro Luxatemp AM Plus 1+15 BL USA Luxatemp DKS 1+15 A20 LUMI USA Luxatemp AM Solar Plus 1+15 A2 Luxatemp AM Plus 1+15 A2 USA Luxatemp AM Plus 5+75 A20 USA Luxatemp Fluorescence A3 ReUSA Luxatemp DKS 1+15 A10 LUMI USA Luxatemp AM Plus 1+15 B1 USA Luxatemp Fluoro 10ml A2 USA Luxatemp AM Plus 5+75 A10 USA Luxatemp Fluorescence 10ml BL Luxatemp Fluorescence 10ml A2 Luxatemp Fluorescence 10ml B1 Luxatemp AM Plus A35 5+75 TempoCem AM NE Intro USA TempoCem AM NE Refill 1+40 USA TEMPOCEM NE SMARTMIX USA LUXABITE AM 25 MK USA Smartmix-Tips Combi USA Automix-Dispenser 50 1:1 USA Automix-Tips Yellow 1:1 35x + Tüte mit 50 MK MB 5.4-12D USA Luxaflow Mischkanülen USA Constic Accessories USA Endo-Smartmix-Tips 20x Smartmix-Tips 50x USA Smartmix-Tips 4:1 50ST USA Luxatemp AM Zub Dispenser USA Prokb AM Zub 25 MK-Mbx USA Luxatemp AM Zub Plunger USA Smartmix-Tips 4:1 50ST Automix-Tips Blue 1:1 50 Stk U Automix-Tips Green 1:1 50x USA Smartmix-Tips 4:1 USA Intraoral-Tips Transp.50x USA Luxatemp AM Zub Plunger Vitique Conturat. Tips 100 USA Automix-Dispenser Type 25 1:1 Constic Accessories Mixstar-Tips blue 50x USA Vitique Conturation Tips 100 Smartmix-Tips Green-Blue 25xUS Safetip Dispenser Pro Icon Vestibular Tips Icon vestibular 7 units USA Icon approximal 7 units USA Icon-Etch Refill USA Icon approximal 2 units USA Icon vestibular 2 units USA Icon Wedges Icon Capillary Tips Icon Proximal Tips Luxaglaze 5 ml Ionosit Microspand 10x 0,3g Ionosit Baseliner 2x 1.5g USA Ionosit Baseliner 10x 0.3g USA Sample Baseliner 1x 0.3g USA Kit LX-Plus A2+Ionosit BL Kit LX-Ultra A2+Ionosit BL Ionosit Microspand 1x 0,3g LuxaCore Z-Dual AM A3 USA LuxaCore Z-Dual SM A3 USA LuxaCore Z-Dual Smartmix blue LuxaCore Z-Dual Automix A3 LuxaCore Z-Dual Smartmix light opaq LuxaCore Z-Dual SM LO USA LuxaCore Z-Dual Automix blue LuxaCore Z-Dual Smartmix A3 LuxaCore Z-Dual AM Blue USA LuxaCore Z-Dual Automix light opaqu LuxaCore Z-Dual SM blau USA LuxaCore Z-Dual AM LO USA TempoCem-Smartmix USA TempoCem AM Refill 1+40 USA PermaCem AM Dual Refill Perma Cem 1+40 TECO Introkit SilvR dose USA LuxaBond Pre-Bond Refill LuxaBond Total Etch USA Vitique Silane 2-Komponenten TECO Introkit SilvR dose MixStar eMotion 115 V USA MK Status Blue 25 ST USA MixStar-Tips 50x USA MixStar-eMotion Vitique Try In B1 Vitique Basis White Vitique Basis A4 Contax Intro + Activator Contax Intro + Activator USA Vitique Try In White USA Vitique Try In A2,5 Vitique Cement A4 Vitique Intro Kit USA Vitique Try In White Vitique Cement A1 Vitique Cement B1 Vitique Veneer Cementation Kit Contax-Primer Refill USA Vitique Try In A1 Vitique Cement Pink Vitique Cement BL Contax-Primer Refill Vitique Starter Kit Vitique Cement Transparent Vitique Cement White Vitique Cement A2,5 Silane 2-Komponenten USA Vitique Try In BL Contax-Bond Refill Vitique Basis B1 Vitique Try In Pink Vitique Basis A2,5 Vitique Basis Pink Vitique Try In A4 Contax-Activator Refill Vitique Catalyst High Viscosity Vitique Try In Catalyst Shade Vitique Basis Transparent Vitique Basis A1 Vitique Catalyst Low Viscosity Vitique Basis BL Vitique Try In Transparent Luxaflow Floures. Intro USA Luxaflow Fluores. A3 Refill US Luxaflow Refill B1 Extra Light Luxaflow Refill A10 USA Luxaflow Refill A35 Luxaflow Fluores. A20 Refill Luxaflow A20 Refill Luxaflow Fluores. E-Light Ref. Luxaflow Fluores. A10 Refill Luxaflow Fluores. A35 Refill LuxaFlow Ultra BL Ecosite Bulk Fill Set 4g USA Ecosite Bulk 16x0.25 contr.USA Ecosite Bulk Fill Set 0.25g USA Ecosite Bulk 16x0.25 univ. USA Ecosite Bulk Fill 4g univ. USA Ecosite Bulk 16x0.25 light USA Ecosite Bulk Fill 4g light USA Ecosite Bulk Fill 4g contr.USA Ecosite One 4 g USA Ecosite One Sample USA Ecosite One 16x0.25 g USA Status Blue MS 1+10 USA Status Blue 8x50ml Bulk for Tub PermaCem Smartmix Dual USA Icon tooth-brush Constic A1 Constic Opak-Weiss Constic A3,5 Constic B1 Constic Opaque-White USA Constic A3 Constic A2 Icon X-ray holder Refill Size 1 X-Ray film holder - Dixi B2 X-Ray film holder - Dixi B1 Icon X-ray holder Size 1 20+2 Icon X-ray holder Size 2 20+2 Icon X-ray holder Refill Size 2 Icon X-ray holder Intro Kit Honigum AM Heavy Fast USA Honigum AM Mono 50ml USA Honigum Light AM 2x50 USA Honigum Light QuadFast2x50 USA Honigum AM Light Fast 4x 25 ml Honigum AM Light 4x25 USA Honigum AM Heavy USA Honigum MS Mono 1+10 USA Honigum MS Heavy 1x USA Honigum MS Heavy Fast 1+10 USA Honigum MS Putty 1+10 USA Impression Material Rigid Fast Honigum Pro Trial Kit Fast Honigum Trial Kit USA Honigum Pro Trial Kit Reg Honigum Pro Heavy 1*380+10 Honigum Pro Heavy Fast AM USA Mono 1*380 ml+10 Honigum Pro Heavy MS 1x USA Honigum Pro Mono MS 1x Honigum Pro Putty MS 1x Honigum Pro Mono 2*50 ml+4 Honigum Pro Heavy Fast 1MS USA Honigum Pro Light Fast AM 4x25 Honigum Pro Heavy AM USA Honigum Pro Heavy Fast 1MS Honigum Pro Light Fast 4x25 US Honigum Pro Mono AM 50ml USA Honigum Pro Light AM 4x25 USA Honigum ProLightQuadFast2x50US Honigum ProLightQuad Fast 2x50 Honigum Pro Mono MS 1x USA Honigum Pro Light 2*50 ml Honigum Pro Light 2x50ml USA Honigum Pro Putty MS 1x USA Honigum Pro Trial Kit USA Honigum Pro Mono Fast 50 ml Honigum Pro Rigid Fast 50 ml Honigum Rigid X-tra Fast4x50ml Honigum Mono Quad Fast 4x50 ml Tray Adhesive 1x 10ml USA Silagum AM Comfort Primer Refi Silagum AM Comfort Varnish Ref Silagum Comfort 1x50ml + 12 Luxatemp-Ultra AM A3,5 USA Luxatemp-Ultra SM BL USA Luxatemp-Ultra AM A2 USA Luxatemp-Ultra AM B1 USA Luxatemp-Ultra AM A1 USA Luxatemp-Ultra AM BL USA Luxatemp-Ultra AM A3 USA Luxatemp-Ultra SM A2 USA Luxatemp-Ultra SM B1 USA TempoCemID Smartmix Temp Tabs Natural DMG Etching Gel Medium Viscosi DMG Etching Gel Jumbo O-Bite 4x50ml+15 USA LUXABITE AUTOMIX NPA USA Microbrushes Weiss 25 Stk Microbrushes X Red 25 Stck. Microbrushes X SCHW 25 Stck. Endobrushes 25 St USA Endobrushes Black 25 St USA Ecu-Pen Microtip Applicator QuikGlaze XL QuikGlaze LuxaPost PS Refill 1.5 USA LuxaPost PS Refill 1.375 USA LuxaPost PS Refill 1.25 USA

    Establishment Types

    Manufacture Medical Device