Medical Device Manufacturer · US , Watertown , MA

Pulpdent Corporation

32 submissions · 32 cleared · Since 2002
32
Total
32
Cleared
0
Denied

Pulpdent Corporation — FDA 510(k) Submissions

Pulpdent Corporation has submitted 32 FDA 510(k) premarket notifications since 2002, of which 32 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Material, Tooth Shade, Resin, Cement, Dental, Agent, Tooth Bonding, Resin, Sealant, Pit And Fissure, And Conditioner, Varnish, Cavity . Use the specialty filter in the sidebar to narrow results.

32 devices
1–25 of 32
ACTIVA PRESTO PACK
K210045 · EBF Material, Tooth Shade, Resin · Dental
Sep 2021 257d
OBA-MCP, Orthodontic Bracket Adhesive with MCP
K173020 · DYH Adhesive, Bracket And... · Dental
Jan 2018 111d
Pulpdent (Activa) Pit and Fissure Sealant with MCP
K172169 · EBC Sealant, Pit And Fissure,... · Dental
Jan 2018 171d
Pulpdent Solo Flowable Composite with MCP
K153249 · EBF Material, Tooth Shade, Resin · Dental
Apr 2016 144d
RMGI FILL
K130223 · EMA Cement, Dental · Dental
Mar 2013 59d
RMGI LOW VISCOSITY
K123265 · EMA Cement, Dental · Dental
Dec 2012 49d
TUFF-TEMP 2.0
K120784 · EBG Crown And Bridge,... · Dental
Jun 2012 85d
NUCAL
K120003 · EJK Liner, Cavity, Calcium... · Dental
Apr 2012 93d
ETCH-RITE SUPREME
K120213 · KLE Agent, Tooth Bonding, Resin · Dental
Mar 2012 66d
EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL
K113818 · EBC Sealant, Pit And Fissure,... · Dental
Mar 2012 85d
LIME-LITE II
K113711 · EJK Liner, Cavity, Calcium... · Dental
Mar 2012 77d
SPEE-DEE PATCH
K113617 · EBF Material, Tooth Shade, Resin · Dental
Mar 2012 86d
ACTIV VARNISH
K112946 · LBH Varnish, Cavity · Dental
Dec 2011 66d
PULPDENT COPAL VARNISH WITH FLUORIDE
K100503 · LBH Varnish, Cavity · Dental
May 2010 79d
PULPDENT FLUORIDE VARNISH
K093620 · LBH Varnish, Cavity · Dental
Mar 2010 107d
ORALUBE
K090457 · ONK Oral Lubricant · Dental
May 2009 87d
PULPDENT MICRO-HYBRID COMPOSITE
K090391 · EBF Material, Tooth Shade, Resin · Dental
May 2009 83d
PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL
K081810 · EBG Crown And Bridge,... · Dental
Sep 2008 83d
EMBRACE DUAL CURE COMPOSITE MATERIALS
K071278 · EBF Material, Tooth Shade, Resin · Dental
Jun 2007 53d
EMBRACE WETBOND CLEAR SEALANT
K052281 · EBC Sealant, Pit And Fissure,... · Dental
Feb 2006 170d
PULPDENT VLC RESIN CEMENT
K040236 · EMA Cement, Dental · Dental
Apr 2004 78d
EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT
K032953 · KLE Agent, Tooth Bonding, Resin · Dental
Dec 2003 79d
PULPDENT ETCH-RITE ROYALE
K031915 · KLE Agent, Tooth Bonding, Resin · Dental
Aug 2003 46d
EMBRACE WET-BOND RESTORATIVE MATERIAL
K031877 · EBF Material, Tooth Shade, Resin · Dental
Aug 2003 45d
TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT
K030036 · DYH Adhesive, Bracket And... · Dental
Mar 2003 68d
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