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Pulpdent Corporation

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
32
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K210045ACTIVA PRESTO PACKSeptember 22, 2021
K173020OBA-MCP, Orthodontic Bracket Adhesive with MCPJanuary 17, 2018
K172169Pulpdent (Activa) Pit and Fissure Sealant with MCPJanuary 5, 2018
K153249Pulpdent Solo Flowable Composite with MCPApril 1, 2016
K130223RMGI FILLMarch 29, 2013
K123265RMGI LOW VISCOSITYDecember 7, 2012
K120784TUFF-TEMP 2.0June 8, 2012
K120003NUCALApril 5, 2012
K120213ETCH-RITE SUPREMEMarch 30, 2012
K113818EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILLMarch 21, 2012
K113711LIME-LITE IIMarch 5, 2012
K113617SPEE-DEE PATCHMarch 2, 2012
K112946ACTIV VARNISHDecember 9, 2011
K100503PULPDENT COPAL VARNISH WITH FLUORIDEMay 12, 2010
K093620PULPDENT FLUORIDE VARNISHMarch 10, 2010
K090457ORALUBEMay 21, 2009
K090391PULPDENT MICRO-HYBRID COMPOSITEMay 11, 2009
K081810PULPDENT TEMPORARY CROWN AND BRIDGE MATERIALSeptember 17, 2008
K071278EMBRACE DUAL CURE COMPOSITE MATERIALSJune 29, 2007
K052281EMBRACE WETBOND CLEAR SEALANTFebruary 8, 2006