FDA 510(k) Applications Submitted by Colleen Boswell

FDA 510(k) Number Submission Date Device Name Applicant
K020091 01/10/2002 OPTILUX 501 KERR CORPORATION (DANBURY)
K020092 01/10/2002 TEMPHASE KERR DENTAL MATERIALS CENTER
K080089 01/14/2008 SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS SYBRON DENTAL SPECIALTIES, INC.
K140120 01/16/2014 EPIC 10 BIOLASE, INC.
K020178 01/18/2002 BELLEGLASS HP MODELING GEL KERR DENTAL MATERIALS CENTER
K990225 01/25/1999 ENDO ANALYZER, MODEL 8005, MODIFIED SYBRON DENTAL SPECIALTIES, INC.
K020267 01/25/2002 OPTILUX CURING LIGHTS SYBRON DENTAL SPECIALTIES, INC.
K050180 01/26/2005 EXPA-SYL PRODUITS DENTAIRES PIERRE ROLLAND
K990252 01/27/1999 SOLO PLUS ORTHO SYBRON DENTAL SPECIALTIES, INC.
K000269 01/28/2000 BELLEGLASS HP OPACEOUS DENTIN SYBRON DENTAL SPECIALTIES, INC.
K020303 01/29/2002 XR PRIMER 2 KERR DENTAL MATERIALS CENTER
K000346 02/03/2000 EZ CONNECT KERR DENTAL MATERIALS CENTER
K000357 02/04/2000 EZ CONNECT RESIN KERR DENTAL MATERIALS CENTER
K070327 02/05/2007 REMOVABLE ARYLIC HERBST, ALLESEE SNORE APPLIANCE (ASA), AND ENOCH SNORINATOR SYBRON DENTAL SPECIALTIES, INC.
K000436 02/10/2000 BELLEGLASS HP TRANSLUCENT DENTIN SYBRON DENTAL SPECIALTIES, INC.
K020502 02/14/2002 SOLO ORTHO 3 SYBRON DENTAL SPECIALTIES, INC.
K990498 02/17/1999 OPTIBOND SOLO PLUS SYBRON DENTAL SPECIALTIES, INC.
K000530 02/17/2000 BELLEGLASS HP ENAMEL SYBRON DENTAL SPECIALTIES, INC.
K060469 02/23/2006 OPTIBOND ALL-IN-ONE SYBRON DENTAL SPECIALTIES, INC.
K060472 02/23/2006 PREMISE FLOWABLE KERR CORPORATION
K130465 02/25/2013 EPIC 10S BIOLASE TECHNOLOGY, INC.
K970715 02/27/1997 SYSTEM B HEAT SOURCE SYBRON DENTAL SPECIALTIES, INC.
K030646 02/28/2003 BELLEGLASS POINT 4 KERR DENTAL MATERIALS CENTER
K080612 03/04/2008 LEICA FL800 LEICA MICROSYSTEMS (SCHWEIZ) AG
K990739 03/05/1999 QUANTEC-E ENDO SYSTEM SYBRON DENTAL SPECIALTIES, INC.
K990743 03/08/1999 SOLO ORTHO SYBRON DENTAL SPECIALTIES, INC.
K050604 03/09/2005 KERR VPS IMPRESSION MATERIAL SYBRON DENTAL SPECIALTIES, INC.
K160720 03/16/2016 Carriere Motion Clear Class II ORTHO ORGANIZERS, INC.
K990898 03/18/1999 PRODIGY 4 SYBRON DENTAL SPECIALTIES, INC.
K160784 03/22/2016 CAM Titanium Blanks ALTATEC GMBH
K991035 03/29/1999 QUANTEC-E IRRIGATION SYSTEM SYBRON DENTAL SPECIALTIES, INC.
K010940 03/29/2001 SEALAPEX 4 SYBRON DENTAL SPECIALTIES, INC.
K040874 04/02/2004 RED, WHITE & BLUE ALLESEE ORTHODONTIC APPLIANCES
K010994 04/03/2001 TAKE ONE BITE MODIFIED KERR CORP.
K061042 04/14/2006 LINGLOCK SYBRON DENTAL SPECIALTIES
K021253 04/19/2002 ULTRASONIC TIPS WITH DIAMOND COATING SYBRON ENDO/ANALYTIC
K050984 04/19/2005 BIOPLANT KERR DENTAL MATERIALS CENTER
K021298 04/24/2002 ELEMENTS DIAGNOSTIC UNIT SYBRON ENDO/ANALYTIC
K061230 05/02/2006 VECTORS TEMPORARY ANCHORAGE SYSTEM SYBRON DENTAL SPECIALTIES
K071251 05/04/2007 DEMI KERR CORPORATION
K031444 05/07/2003 OPTIBOND FL KERR DENTAL MATERIALS CENTER
K071288 05/08/2007 MODIFICATION TO KAVO QUATTROCARE SYBRON DENTAL SPECIALTIES, INC.
K031476 05/09/2003 FILL-IN SYBRON DENTAL SPECIALTIES, INC.
K031484 05/12/2003 STAND OUT KERR CORP.
K231389 05/12/2023 Harvest Dental HD Gum Strip Harvest Dental Products, LLC
K071429 05/23/2007 TI2200 TRANSILLUMINATION CABLE KERR CORPORATION
K991808 05/27/1999 OPTIBOND SOLO PLUS 2 SYBRON DENTAL SPECIALTIES, INC.
K031664 05/29/2003 ELEMENTS OBTURATION UNIT SYBRON ENDO/ANALYTIC
K061481 05/30/2006 GRENGLOO ORMCO CORP.
K001655 05/31/2000 PERMLASTIC 2 KERR CORP.
K021797 05/31/2002 L.E.DEMETRON SYBRON DENTAL SPECIALTIES, INC.
K041474 06/02/2004 MAXCEM SYBRON DENTAL SPECIALTIES, INC.
K091613 06/03/2009 TAKE 1 KERR CORP.
K011798 06/08/2001 CORERESTORE 2 SYBRON DENTAL SPECIALTIES, INC.
K041527 06/08/2004 AARHUS ANCHORAGE SYSTEM MEDICON, E.G.
K051545 06/10/2005 L.E. DEMETRON II KERR CORPORATION (DANBURY)
K151599 06/12/2015 iSy Implant System Altatec GmbH
K071615 06/13/2007 FIXAFLOSS SYBRON DENTAL SPECIALTIES, INC.
K982148 06/18/1998 PRODIGY 2 SYBRON DENTAL SPECIALTIES, INC.
K992067 06/18/1999 BELLEGLAZE KERR DENTAL MATERIALS CENTER
K011908 06/19/2001 OPTIBOND SOLO PLUS 3 KERR DENTAL MATERIALS CENTER
K001876 06/20/2000 TAKE 1 BITE SYBRON DENTAL SPECIALTIES, INC.
K001881 06/21/2000 IMPROVED ENLIGHT LV SYBRON DENTAL SPECIALTIES, INC.
K001899 06/22/2000 IMPROVED TRY-IN GEL SYBRON DENTAL SPECIALTIES, INC.
K992118 06/23/1999 PRODIGY 4 TRANSLUCENT SHADES SYBRON DENTAL SPECIALTIES, INC.
K992160 06/25/1999 NEXUS 2 SYBRON DENTAL SPECIALTIES, INC.
K992195 06/29/1999 QUANTEC-E IRRIGATION SYSTEM 2 SYBRON DENTAL SPECIALTIES, INC.
K032042 07/01/2003 ENVISION SYBRON DENTAL SPECIALTIES, INC.
K012082 07/03/2001 OPTIBOND SOLO PLUS ACTIVATOR SYBRON DENTAL SPECIALTIES, INC.
K051933 07/13/2005 EXPASYL POWER APPLICATOR SYBRON DENTAL SPECIALTIES, INC.
K982459 07/15/1998 TEMPFIL F - 2 SYBRON DENTAL SPECIALTIES, INC.
K141975 07/21/2014 WATERLASE IPLUS S BIOLASE, INC.
K012321 07/23/2001 POINT 4 FLOWABLE SYBRON DENTAL SPECIALTIES, INC.
K012322 07/23/2001 OPTIBOND 2 SYBRON DENTAL SPECIALTIES, INC.
K982590 07/24/1998 TEMPBOND CLEAR-2 SYBRON DENTAL SPECIALTIES, INC.
K012405 07/30/2001 EXTRUDE MODIFIED SYBRON DENTAL SPECIALTIES, INC.
K072114 08/01/2007 IMPULSE 6000D/7000DP FLUKE BIOMEDICAL
K032408 08/04/2003 DAMON FT SYBRON DENTAL SPECIALTIES, INC.
K032407 08/04/2003 OPTIBAND LC SYBRON DENTAL SPECIALTIES, INC.
K012717 08/15/2001 LIFE 2 SYBRON DENTAL SPECIALTIES, INC.
K222489 08/17/2022 Harvest Printable Resin Harvest Dental Products, LLC
K982917 08/19/1998 B-SYSTEM SILICONE SYBRON DENTAL SPECIALTIES, INC.
K062519 08/28/2006 NEXUS 3 KERR CORPORATION
K152509 09/02/2015 CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR) ALTATEC GMBH
K983091 09/03/1998 ELAN-2 KERR DENTAL MATERIALS CENTER
K013008 09/06/2001 NEXUS 2 MODIFIED SYBRON DENTAL SPECIALTIES, INC.
K013009 09/06/2001 BELLEGLASS HP DC OPACEOUS DENTIN LCTE 2 SYBRON DENTAL SPECIALTIES, INC.
K013007 09/06/2001 BELLEGLASS HP ENAMEL 2 SYBRON DENTAL SPECIALTIES, INC.
K042422 09/07/2004 D3 CHROMA SYBRON DENTAL SPECIALTIES, INC.
K052477 09/09/2005 DAMON 3 MODIFIED ORMCO CORP.
K973439 09/10/1997 ENDO ANALYZER, MODEL 8005 SYBRON DENTAL SPECIALTIES, INC.
K032921 09/22/2003 PREMISE SYBRON DENTAL SPECIALTIES, INC.
K963862 09/24/1996 TOUCH N' HEAT SYBRON DENTAL SPECIALTIES, INC.
K983370 09/24/1998 PRODIGY- 3 SYBRON DENTAL SPECIALTIES, INC.
K013185 09/24/2001 TCM ENDO III NOUVAG AG
K062856 09/25/2006 TF ROTARY NICKEL TITANIUM FILE ORMCO CORP.
K222961 09/27/2022 Harvest Conceal ZR Block Out Harvest Dental Products, LLC
K013325 10/05/2001 POINT 4 FLOWABLE 2 KERR DENTAL MATERIALS CENTER
K013375 10/11/2001 BELLEGLASS HP OPAQUE 2 KERR DENTAL MATERIALS CENTER
K063116 10/12/2006 DEMETRON A.2 SYBRON DENTAL SPECIALTIES
K042888 10/19/2004 DEMETRON IDS CURING LIGHT KERR CORP.
K013510 10/22/2001 POINT 4 MODIFIED SYBRON DENTAL SPECIALTIES, INC.
K013529 10/23/2001 POINT 4 TRANSLUCENT MODIFIED SYBRON DENTAL SPECIALTIES, INC.
K013609 10/31/2001 NEXUS 2 CLEAR SYBRON DENTAL SPECIALTIES, INC.
K013647 11/05/2001 REVOLUTION FORMULA 2 SYBRON DENTAL SPECIALTIES, INC.
K173440 11/06/2017 Carriere SLX 3D Clear Ortho Organizers, Inc.
K083347 11/13/2008 IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS FLUKE BIOMEDICAL
K073209 11/14/2007 MAXCEM 2 KERR CORPORATION
K123595 11/21/2012 NEXUS RMGI KERR CORPORATION
K013895 11/23/2001 TEMPFIL SYBRON DENTAL SPECIALTIES, INC.
K984217 11/24/1998 ENLIGHT-2 SYBRON DENTAL SPECIALTIES, INC.
K003650 11/27/2000 PERMLASTIC 3 SYBRON DENTAL SPECIALTIES, INC.
K003658 11/28/2000 TEMP-BOND NE 2 SYBRON DENTAL SPECIALTIES, INC.
K014027 12/06/2001 OPTIBOND SOLO PLUS 4 KERR DENTAL MATERIALS CENTER
K984362 12/07/1998 ENLIGHT LV SYBRON DENTAL SPECIALTIES, INC.
K003808 12/08/2000 TAKE 1 SYBRON DENTAL SPECIALTIES, INC.
K073478 12/11/2007 SUPERTORQUE HIGH-SPEED HANDPIECES AND GENTLEPOWER HANDPIECES AND ATTACHEMENTS SYBRON DENTAL SPECIALTIES, INC.
K014179 12/20/2001 DEMETRON LC KERR CORP.
K024198 12/20/2002 SMEARCLEAR SYBRON DENTAL SPECIALTIES, INC.
K053565 12/22/2005 TEMPBOND CLEAR WITH TRICLOSAN SYBRON DENTAL SPECIALTIES, INC.
K153779 12/31/2015 Abutment for Bridges ALTATEC GmbH


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