FDA 510(k) Applications Submitted by DMG USA, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K160443 |
02/17/2016 |
TempoCem Clear |
DMG USA, INC. |
| K100062 |
01/11/2010 |
INFILTRATION KIT |
DMG USA, INC. |
| K080479 |
02/22/2008 |
DENTAL CERAMIC |
DMG USA, INC. |
| K080480 |
02/22/2008 |
NANOCOMPOSITE RESTORATIVE KIT |
DMG USA, INC. |
| K110759 |
03/18/2011 |
TEMPOCEM |
DMG USA, INC. |
| K000878 |
03/20/2000 |
HONIGUM |
DMG USA, INC. |
| K000951 |
03/23/2000 |
LUXAFORM |
DMG USA, INC. |
| K011211 |
04/19/2001 |
FLOWABLE COMPOSITE/ ECUFLOW/ LUXAFLOW |
DMG USA, INC. |
| K081493 |
05/28/2008 |
INFILTRATION KIT |
DMG USA, INC. |
| K101710 |
06/17/2010 |
LUXATEMP ULTRA /STAR |
DMG USA, INC. |
| K002086 |
07/10/2000 |
PRIMAFLOW |
DMG USA, INC. |
| K041960 |
07/21/2004 |
COMPOSITE/COMPOMER REPAIR KIT |
DMG USA, INC. |
| K012307 |
07/23/2001 |
LUXACORE/LUXACORE DUAL |
DMG USA, INC. |
| K012316 |
07/23/2001 |
PERMACEM / PERMACEM DUAL |
DMG USA, INC. |
| K102603 |
09/10/2010 |
SA FLOWABLE ADHESIVE |
DMG USA, INC. |
| K013179 |
09/24/2001 |
LUXAGLAZE |
DMG USA, INC. |
| K013236 |
09/28/2001 |
LUXABITE |
DMG USA, INC. |
| K013237 |
09/28/2001 |
STATUSBLUE |
DMG USA, INC. |
| K052800 |
10/03/2005 |
PROVISIONAL INLAY/ONLAY KIT |
DMG USA, INC. |
| K033227 |
10/06/2003 |
LUXAFORM PLUS |
DMG USA, INC. |
| K093338 |
10/23/2009 |
SELF ADHESIVE COMPOSITE LUTING CEMENT |
DMG USA, INC. |
| K013571 |
10/29/2001 |
MAGICFIL |
DMG USA, INC. |
| K023649 |
10/30/2002 |
VITIQUE SYSTEM |
DMG USA, INC. |
| K013674 |
11/07/2001 |
LUXATEMP/LUXATEMP SOLAR/INSTATEMP |
DMG USA, INC. |
| K063444 |
11/15/2006 |
TOTAL ETCH BONDING AGENT |
DMG USA, INC. |
| K093587 |
11/19/2009 |
DENTAL MERCURY |
DMG USA, INC. |
| K130580 |
03/05/2013 |
RETRACTION PASTE |
DMG USA, INC. |
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