FDA 510(k) Applications Submitted by Kenneth J Berk

FDA 510(k) Number Submission Date Device Name Applicant
K030036 01/03/2003 TRIPLE-CURE PASTE/PASTE RESIN-REINFORCED GLASS IONOMER CEMENT PULPDENT CORPORATION
K120003 01/03/2012 NUCAL PULPDENT CORPORATION
K020115 01/11/2002 PULPDENT SEALANT/PASTE ORTHODONTIC BRACKET ADHESIVE SYSTEM PULPDENT CORP.
K120213 01/24/2012 ETCH-RITE SUPREME PULPDENT CORPORATION
K020287 01/28/2002 DENTITION INTEGRATING MATERIAL PULPDENT CORPORATION
K130223 01/29/2013 RMGI FILL PULPDENT CORPORATION
K040236 02/02/2004 PULPDENT VLC RESIN CEMENT PULPDENT CORPORATION
K020432 02/08/2002 PULPDENT GLAZE PULPDENT CORPORATION
K020481 02/13/2002 PULPDENT POST CEMENT PULPDENT CORPORATION
K020514 02/15/2002 PULPDENT GLAZE II PULPDENT CORPORATION
K090391 02/17/2009 PULPDENT MICRO-HYBRID COMPOSITE PULPDENT CORPORATION
K100503 02/22/2010 PULPDENT COPAL VARNISH WITH FLUORIDE PULPDENT CORPORATION
K090457 02/23/2009 ORALUBE PULPDENT CORPORATION
K120784 03/15/2012 TUFF-TEMP 2.0 PULPDENT CORPORATION
K961089 03/19/1996 PULPDENT ENDOPREP II PULPDENT CORP.
K971594 05/01/1997 FLOW-RITE PULPDENT CORP.
K071278 05/07/2007 EMBRACE DUAL CURE COMPOSITE MATERIALS PULPDENT CORPORATION
K031877 06/17/2003 EMBRACE WET-BOND RESTORATIVE MATERIAL PULPDENT CORPORATION
K962383 06/20/1996 PULPDENT RESILUTE II PULPDENT CORP.
K031915 06/20/2003 PULPDENT ETCH-RITE ROYALE PULPDENT CORPORATION
K081810 06/26/2008 PULPDENT TEMPORARY CROWN AND BRIDGE MATERIAL PULPDENT CORPORATION
K972445 06/30/1997 PULPDENT OX-OUT PULPDENT CORP.
K962743 07/15/1996 PULPDENT SODIUM HYPOCHLORITE SOLUTION PULPDENT CORP.
K962747 07/15/1996 PULPDENT ENDODONTIC POST CEMENT KIT PULPDENT CORP.
K022492 07/29/2002 PULPDENT SEMI-GEL ETCH PULPDENT CORPORATION
K022522 07/30/2002 PULPDENT PUTTY DAM PULPDENT CORPORATION
K022734 08/16/2002 PULPDENT CALCIUM HYDROXIDE PREPARATION PULPDENT CORPORATION
K052281 08/22/2005 EMBRACE WETBOND CLEAR SEALANT PULPDENT CORPORATION
K963652 09/12/1996 PULPDENT DESENSITIZER PULPDENT CORP.
K032953 09/22/2003 EMBRACE WETBOND RESTORATION AND PFM REPAIR KIT PULPDENT CORPORATION
K963921 09/30/1996 PULPDENT SEAL-RITE UDMA PULPDENT CORP.
K112946 10/04/2011 ACTIV VARNISH PULPDENT CORPORATION
K013411 10/15/2001 PULPDENT CAVITY PREPARATION IV PULPDENT CORP.
K123265 10/19/2012 RMGI LOW VISCOSITY PULPDENT CORPORATION
K974014 10/22/1997 PULPDENT DENTASTIC UNO PULPDENT CORP.
K993683 11/01/1999 PULPDENT UNO-DUO PULPDENT CORP.
K964430 11/05/1996 PULPDENT SNOOP PULPDENT CORP.
K153249 11/09/2015 Pulpdent Solo Flowable Composite with MCP Pulpdent Corporation
K974202 11/10/1997 PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUS PULPDENT CORP.
K974398 11/21/1997 PULPDENT CAVITY VARNISH PULPDENT CORP.
K093620 11/23/2009 PULPDENT FLUORIDE VARNISH PULPDENT CORPORATION
K113617 12/07/2011 SPEE-DEE PATCH PULPDENT CORPORATION
K994182 12/10/1999 PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 WITH FLUORIDE PULPDENT CORP.
K994180 12/10/1999 PULPDENT CAVITY PREPARATION III PULPDENT CORP.
K994181 12/10/1999 PULPDENT CAVITY PREPARATION II, PULPDENT CAVITY PREPARATION II WUTH FLUORIDE PULPDENT CORP.
K014059 12/10/2001 PULPDENT TRANS OBA ORTHODONTIC BRACKET ADHESIVE PULPDENT CORP.
K014138 12/17/2001 PULPDENT TRIPLE-CURE REINFORCED GLASS IONOMER ORTHODONTIC CEMENT PULPDENT CORP.
K014133 12/17/2001 PULPDENT NO-MIX ORTHODONTIC BRACKET ADHESIVE PULPDENT CORP.
K113711 12/19/2011 LIME-LITE II PULPDENT CORPORATION
K113818 12/27/2011 EMBRACE WETBOND PIT AND FISSURE SEALANT, LOW FILL PULPDENT CORPORATION
K172169 07/18/2017 Pulpdent (Activa) Pit and Fissure Sealant with MCP Pulpdent Corporation
K173020 09/28/2017 OBA-MCP, Orthodontic Bracket Adhesive with MCP Pulpdent Corporation


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