Data / Medical devices / Germany / DMG Chemisch Pharmazeutische Fabrik GMBH
DMG Chemisch Pharmazeutische Fabrik GMBH: FDA-registered device maker in Hamburg, Germany, 29 510(k) clearances
DMG Chemisch Pharmazeutische Fabrik GMBH is registered with the FDA (registration 8044164) in Hamburg, Germany. It lists 20 device types. The FDA files 29 510(k) clearances under its listings, the newest dated June 1, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 8044164
- FEI number
- 3004150030
- Address
- Elbgaustrasse 248, Hamburg, Germany, D-22547
- Owner or operator
- DMG CHEMISCH PHARMAZEUTISCHE FABRIK GMBH (9005969)
- Roles
- Manufacturer
- First device listed
- December 13, 2007
- Registered through
- 2026
- Brand names listed
- Automix-Dispenser 50 1:1 USA, Automix-Dispenser Type 25 1:1, Automix-Tips Blue 1:1 50 Stk U, Automix-Tips Green 1:1 50x USA, Automix-Tips Yellow 1:1 35x +, Constic A1, Constic A2, Constic A3 and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| June 1, 2022 | K213201 | DeltaFil, DeltaFil Conditioner | EMA | Substantially Equivalent | DMG Chemisch-Pharmazeutische Fabrik GmbH | accessdata.fda.gov |
| May 29, 2019 | K183337 | LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2 | EBG | Substantially Equivalent | DMG Chemisch-Pharmazeutische Fabrik GmbH | accessdata.fda.gov |
| January 31, 2018 | K171772 | Ecosite Bulk Fill | EBF | Substantially Equivalent | Dmg USA, Inc. | accessdata.fda.gov |
| September 30, 2016 | K160443 | TempoCem Clear | EMA | Substantially Equivalent | Dmg USA, Inc. | accessdata.fda.gov |
| July 11, 2013 | K131248 | ETCH GEL | KLE | Substantially Equivalent | Dmg America, LLC | accessdata.fda.gov |
| June 10, 2011 | K110759 | TEMPOCEM | EMB | Substantially Equivalent | Dmg USA, Inc. | 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 |
| March 26, 2010 | K100062 | INFILTRATION KIT | EBC | 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 22, 2001 | K013237 | STATUSBLUE | ELW | Substantially Equivalent | Dmg USA, Inc. | accessdata.fda.gov |
| October 17, 2001 | K013236 | LUXABITE | ELW | 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 | K012316 | PERMACEM / PERMACEM DUAL | EMA | 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 |
| April 11, 2000 | K000878 | HONIGUM | ELW | 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 9, 1998 | K982895 | STERNOMEGA COMPOMER CEMENT | EMA | Substantially Equivalent | Sterngold/Implamed | accessdata.fda.gov |
| June 3, 1997 | K970774 | TEMPOCEM NE (MULTIPLE) | EMA | Substantially Equivalent | Foremost Dental Mfg., Inc. | accessdata.fda.gov |
| January 21, 1994 | K935689 | IONOSIT BASE LINER | EBD | Substantially Equivalent | Foremost Dental Mfg., Co. | 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 |
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Updated June 1, 2022. 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.