Not currently registered with FDA under this name
Dmg USA, Inc.
Attleboro, MA, United States. Named as applicant on 27 dental 510(k) clearances between 2000 and 2018. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 272000–2018
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 2000–2026
510(k) clearances
Clearances on which FDA names Dmg USA, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 31 Jan 2018 | K171772 | Ecosite Bulk Fill | EBF Resin Tooth Shade Material |
| 30 Sep 2016 | K160443 | TempoCem Clear | EMA Dental Cement |
| 10 Jun 2011 | K110759 | TEMPOCEM | EMB Zinc Oxide Eugenol |
| 17 Nov 2010 | K102603 | SA FLOWABLE ADHESIVE | EBF Resin Tooth Shade Material |
| 28 Sep 2010 | K101710 | LUXATEMP ULTRA /STAR | EBG Resin Temporary Crown and Bridge |
| 26 Mar 2010 | K100062 | INFILTRATION KIT | EBC Pit and Fissure Sealant and Conditioner |
| 12 Feb 2010 | K093338 | SELF ADHESIVE COMPOSITE LUTING CEMENT | EMA Dental Cement |
| 21 Jan 2010 | K093587 | DENTAL MERCURY | ELY Mercury |
| 18 Sep 2008 | K081493 | INFILTRATION KIT | EBC Pit and Fissure Sealant and Conditioner |
| 30 May 2008 | K080480 | NANOCOMPOSITE RESTORATIVE KIT | EBF Resin Tooth Shade Material |
| 21 May 2008 | K080479 | DENTAL CERAMIC | EIH Porcelain Powder |
| 20 Mar 2007 | K063444 | TOTAL ETCH BONDING AGENT | KLE Resin Tooth Bonding Agent |
| 7 Mar 2006 | K052800 | PROVISIONAL INLAY/ONLAY KIT | EBG Resin Temporary Crown and Bridge |
| 30 Aug 2004 | K041960 | COMPOSITE/COMPOMER REPAIR KIT | KLE Resin Tooth Bonding Agent |
| 16 Jan 2004 | K033227 | LUXAFORM PLUS | EBG Resin Temporary Crown and Bridge |
| 17 Jan 2003 | K023649 | VITIQUE SYSTEM | EMA Dental Cement |
| 24 Jan 2002 | K013674 | LUXATEMP/LUXATEMP SOLAR/INSTATEMP | EBG Resin Temporary Crown and Bridge |
| 17 Jan 2002 | K013571 | MAGICFIL | EBF Resin Tooth Shade Material |
| 22 Oct 2001 | K013237 | STATUSBLUE | ELW Impression Material |
| 17 Oct 2001 | K013236 | LUXABITE | ELW Impression Material |
| 12 Oct 2001 | K013179 | LUXAGLAZE | EBD Resin Filling Material Coating |
| 23 Aug 2001 | K012316 | PERMACEM / PERMACEM DUAL | EMA Dental Cement |
| 23 Aug 2001 | K012307 | LUXACORE/LUXACORE DUAL | EBF Resin Tooth Shade Material |
| 18 Jun 2001 | K011211 | FLOWABLE COMPOSITE/ ECUFLOW/ LUXAFLOW | EBF Resin Tooth Shade Material |
| 17 Aug 2000 | K002086 | PRIMAFLOW | EBF Resin Tooth Shade Material |
| 11 Apr 2000 | K000878 | HONIGUM | ELW Impression Material |
| 5 Apr 2000 | K000951 | LUXAFORM | EBG Resin Temporary Crown and Bridge |
Some of these clearances are listed with FDA today by another company: DMG Chemisch-Pharmazeutische Fabrik GmbH (19), indigodental GmbH (12), Dentsply Sirona, Inc. (2), DMG America, L.L.C. (2), Sterngold (2), anax dent GmbH (1).
Sources
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 of the most recent filing, which can be a US agent.