Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8044164

FEI Number

3004150030

Entity Name

DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH

City/State/Country

HAMBURG, DE

Establishment Address

ELBGAUSTRASSE 248, HAMBURG D-22547, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH (Owner Number: 9005969)

Owner / Operator Contact Address

ELBGAUSTRASSE 248, --, HAMBURG, DE-HH D-22547, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K033227

PMA Number

N/A

All Registered 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 Vitique Veneer Accessory Kit LuxaBond Pre-Bond Refill LuxaBond Total Etch USA Vitique Veneer System 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 Veneer System 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 Silane 2-Komponenten Vitique Cement White Vitique Veneer Accessory Kit 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 Kit LX-Plus A2+Ionosit BL Kit LX-Ultra A2+Ionosit BL 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EJL	Bur, Dental	Dental	Class 1	872.3240	2011-05-20
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2007-12-17
EMA	Cement, Dental	Dental	Class 2	872.3275	2012-01-12
EIE	Dam, Rubber	Dental	Class 1	872.6300	2015-06-02
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2007-12-17
EMA	Cement, Dental	Dental	Class 2	872.3275	2007-12-13
EID	Syringe, Restorative And Impression Material	Dental	Class 1	872.4565	2007-12-19
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2010-04-28
EBD	Coating, Filling Material, Resin	Dental	Class 2	872.3310	2007-12-18
EBD	Coating, Filling Material, Resin	Dental	Class 2	872.3310	2007-12-17
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-12-18
EMB	Zinc Oxide Eugenol	Dental	Class 1	872.3275	2011-06-29
EMA	Cement, Dental	Dental	Class 2	872.3275	2007-12-17
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2012-03-08
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2012-03-08
KLE	Agent, Tooth Bonding, Resin	Dental	Class 2	872.3200	2007-12-17
EFD	Amalgamator, Dental, Ac-Powered	Dental	Class 1	872.3100	2007-12-19
EMA	Cement, Dental	Dental	Class 2	872.3275	2007-12-17
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2007-12-17
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2018-02-08
ELW	Material, Impression	Dental	Class 2	872.3660	2007-12-18
EMA	Cement, Dental	Dental	Class 2	872.3275	2007-12-18
EFW	Toothbrush, Manual	Dental	Class 1	872.6855	2012-03-21
EBC	Sealant, Pit And Fissure, And Conditioner	Dental	Class 2	872.3765	2012-09-11
EBF	Material, Tooth Shade, Resin	Dental	Class 2	872.3690	2012-09-11
EGZ	Holder, Film, X-Ray	Dental	Class 1	872.1905	2010-04-16
ELW	Material, Impression	Dental	Class 2	872.3660	2007-12-18
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2007-12-18
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2014-03-07
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2010-10-07
EMA	Cement, Dental	Dental	Class 2	872.3275	2017-01-13
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2011-10-26

Official Correspondent

No official correspondent registered.

US Agent Details

Pamela Papineau Business: Delphi Medical Device Consulting, Inc. Email: delphimdc@comcast.net Phone: (978) 7588322

Related Public Records

Same Entity

DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K972485	Arent, Fox, Kintner, Plotkin & Kahn	CIMPAT N	1997-09-08
K982895	Sterngold/Implamed	STERNOMEGA COMPOMER CEMENT	1998-10-09
K033068	Voco GmbH	IONOFIL COLOR AC	2003-10-31
K062064	Southern Dental Industries, Inc.	RIVA BOND LC	2006-11-09
K940030	Bisco, Inc.	BISCO COMPOSITE	1994-02-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0028-2020	Voco GmbH Anton-Flettner-Str. 1-3 Cuxhaven Germany	2	Grandio SO Heavy Flow Caps, Color A3 - Product Usage: Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.).
Z-0035-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, contents: 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66001710.
Z-0036-2008	Heraeus Kulzer Inc., Dental Products Division	2	Heraeus Kulzer GLUMA Comfort Bond + Desensitizer light curing one component adhesive, Assortment Value Pack 3 x 4 ml, dental bonding agent. Distributed by Heraeus Kulzer, Inc., Armonk, NY; Reorder No. 66018222.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8044164. Last updated year: 2026. Please use registration number 8044164 when referencing this establishment in official correspondence.