Company ยท US
Dmg USA, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2000 to 2018. Name variants (Inc, Corp, punctuation) are merged.
28510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EBF | Material, Tooth Shade, Resin | 7 |
| EBG | Crown And Bridge, Temporary, Resin | 5 |
| EMA | Cement, Dental | 4 |
| ELW | Material, Impression | 3 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 2 |
| KLE | Agent, Tooth Bonding, Resin | 2 |
| EBD | Coating, Filling Material, Resin | 1 |
| EIH | Powder, Porcelain | 1 |
| ELY | Mercury | 1 |
| EMB | Zinc Oxide Eugenol | 1 |
| MVL | Cord, Retraction | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 31, 2018 | K171772 | Ecosite Bulk Fill Dmg USA, Inc. | EBF |
| Sep 30, 2016 | K160443 | TempoCem Clear Dmg USA, Inc. | EMA |
| Feb 25, 2014 | K130580 | RETRACTION PASTE Dmg USA, Inc. | MVL |
| Jun 10, 2011 | K110759 | TEMPOCEM Dmg USA, Inc. | EMB |
| Nov 17, 2010 | K102603 | SA FLOWABLE ADHESIVE Dmg USA, Inc. | EBF |
| Sep 28, 2010 | K101710 | LUXATEMP ULTRA /STAR Dmg USA, Inc. | EBG |
| Mar 26, 2010 | K100062 | INFILTRATION KIT Dmg USA, Inc. | EBC |
| Feb 12, 2010 | K093338 | SELF ADHESIVE COMPOSITE LUTING CEMENT Dmg USA, Inc. | EMA |
| Jan 21, 2010 | K093587 | DENTAL MERCURY Dmg USA, Inc. | ELY |
| Sep 18, 2008 | K081493 | INFILTRATION KIT Dmg USA, Inc. | EBC |
| May 30, 2008 | K080480 | NANOCOMPOSITE RESTORATIVE KIT Dmg USA, Inc. | EBF |
| May 21, 2008 | K080479 | DENTAL CERAMIC Dmg USA, Inc. | EIH |
| Mar 20, 2007 | K063444 | TOTAL ETCH BONDING AGENT Dmg USA, Inc. | KLE |
| Mar 7, 2006 | K052800 | PROVISIONAL INLAY/ONLAY KIT Dmg USA, Inc. | EBG |
| Aug 30, 2004 | K041960 | COMPOSITE/COMPOMER REPAIR KIT Dmg USA, Inc. | KLE |
| Jan 16, 2004 | K033227 | LUXAFORM PLUS Dmg USA, Inc. | EBG |
| Jan 17, 2003 | K023649 | VITIQUE SYSTEM Dmg USA, Inc. | EMA |
| Jan 24, 2002 | K013674 | LUXATEMP/LUXATEMP SOLAR/INSTATEMP Dmg USA, Inc. | EBG |
| Jan 17, 2002 | K013571 | MAGICFIL Dmg USA, Inc. | EBF |
| Oct 22, 2001 | K013237 | STATUSBLUE Dmg USA, Inc. | ELW |
| Oct 17, 2001 | K013236 | LUXABITE Dmg USA, Inc. | ELW |
| Oct 12, 2001 | K013179 | LUXAGLAZE Dmg USA, Inc. | EBD |
| Aug 23, 2001 | K012316 | PERMACEM / PERMACEM DUAL Dmg USA, Inc. | EMA |
| Aug 23, 2001 | K012307 | LUXACORE/LUXACORE DUAL Dmg USA, Inc. | EBF |
| Jun 18, 2001 | K011211 | FLOWABLE COMPOSITE/ ECUFLOW/ LUXAFLOW Dmg USA, Inc. | EBF |
| Aug 17, 2000 | K002086 | PRIMAFLOW Dmg USA, Inc. | EBF |
| Apr 11, 2000 | K000878 | HONIGUM Dmg USA, Inc. | ELW |
| Apr 5, 2000 | K000951 | LUXAFORM Dmg USA, Inc. | EBG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||