Medical Device Manufacturer · US , Ayer , MA

Dmg USA, Inc.

28 submissions · 28 cleared · Since 2000
28
Total
28
Cleared
0
Denied

Dmg USA, Inc. — FDA 510(k) Submissions

Dmg USA, Inc. has submitted 28 FDA 510(k) premarket notifications since 2000, of which 28 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Material, Tooth Shade, Resin, Crown And Bridge, Temporary, Resin, Cement, Dental, Material, Impression, Agent, Tooth Bonding, Resin . Use the specialty filter in the sidebar to narrow results.

28 devices
1–25 of 28
Ecosite Bulk Fill
K171772 · EBF Material, Tooth Shade, Resin · Dental
Jan 2018 231d
TempoCem Clear
K160443 · EMA Cement, Dental · Dental
Sep 2016 226d
RETRACTION PASTE
K130580 · MVL Cord, Retraction · Dental
Feb 2014 357d
TEMPOCEM
K110759 · EMB Zinc Oxide Eugenol · Dental
Jun 2011 84d
SA FLOWABLE ADHESIVE
K102603 · EBF Material, Tooth Shade, Resin · Dental
Nov 2010 68d
LUXATEMP ULTRA /STAR
K101710 · EBG Crown And Bridge,... · Dental
Sep 2010 103d
INFILTRATION KIT
K100062 · EBC Sealant, Pit And Fissure,... · Dental
Mar 2010 74d
SELF ADHESIVE COMPOSITE LUTING CEMENT
K093338 · EMA Cement, Dental · Dental
Feb 2010 112d
DENTAL MERCURY
K093587 · ELY Mercury · Dental
Jan 2010 63d
INFILTRATION KIT
K081493 · EBC Sealant, Pit And Fissure,... · Dental
Sep 2008 113d
NANOCOMPOSITE RESTORATIVE KIT
K080480 · EBF Material, Tooth Shade, Resin · Dental
May 2008 98d
DENTAL CERAMIC
K080479 · EIH Powder, Porcelain · Dental
May 2008 89d
TOTAL ETCH BONDING AGENT
K063444 · KLE Agent, Tooth Bonding, Resin · Dental
Mar 2007 125d
PROVISIONAL INLAY/ONLAY KIT
K052800 · EBG Crown And Bridge,... · Dental
Mar 2006 155d
COMPOSITE/COMPOMER REPAIR KIT
K041960 · KLE Agent, Tooth Bonding, Resin · Dental
Aug 2004 40d
LUXAFORM PLUS
K033227 · EBG Crown And Bridge,... · Dental
Jan 2004 102d
VITIQUE SYSTEM
K023649 · EMA Cement, Dental · Dental
Jan 2003 79d
LUXATEMP/LUXATEMP SOLAR/INSTATEMP
K013674 · EBG Crown And Bridge,... · Dental
Jan 2002 78d
MAGICFIL
K013571 · EBF Material, Tooth Shade, Resin · Dental
Jan 2002 80d
STATUSBLUE
K013237 · ELW Material, Impression · Dental
Oct 2001 24d
LUXABITE
K013236 · ELW Material, Impression · Dental
Oct 2001 19d
LUXAGLAZE
K013179 · EBD Coating, Filling... · Dental
Oct 2001 18d
LUXACORE/LUXACORE DUAL
K012307 · EBF Material, Tooth Shade, Resin · Dental
Aug 2001 31d
PERMACEM / PERMACEM DUAL
K012316 · EMA Cement, Dental · Dental
Aug 2001 31d
FLOWABLE COMPOSITE/ ECUFLOW/ LUXAFLOW
K011211 · EBF Material, Tooth Shade, Resin · Dental
Jun 2001 60d
Filters
All28 Dental 28