FDA 510(k) Applications Submitted by HELEN LEWIS

FDA 510(k) Number Submission Date Device Name Applicant
K070019 01/03/2007 CARRARA VOLUMIA DENTSPLY INTL.
K050208 01/28/2005 FRIADENT ESTHETICAP DENTSPLY INTERNATIONAL
K080203 01/28/2008 MTA ROOT CANAL SEALER DENTSPLY INTERNTIONAL
K160207 01/28/2016 ATLANTIS ISUS Implant Suprastructures DENTSPLY INTERNATIONAL, INC.
K080246 01/31/2008 COMPOSITE ALIGNER BUTTON DENTSPLY INTERNTIONAL
K070307 02/01/2007 STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT DENTSPLY INTERNATIONAL, INC.
K070306 02/01/2007 PAINT- ON POLISH AGENT DENTSPLY INTERNATIONAL, INC.
K160232 02/01/2016 Disposable Barrier Sleeves and Covers DENTSPLY International Inc.
K060293 02/06/2006 TEMPORARY CROWN AND BRIDGE MATERIAL DENTSPLY INTERNATIONAL, INC.
K080311 02/06/2008 MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM DENTSPLY INTERNTIONAL
K140347 02/11/2014 ANKYLOS C/X IMPLANT SYSTEM DENTSPLY INTL., INC.
K050386 02/15/2005 PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM DENTSPLY INTERNATIONAL
K090454 02/23/2009 ALLURE MB CERAMIC BRACKETS DENTSPLY INTERNTIONAL
K070538 02/26/2007 XP BOND DUAL CURE UNIVERSAL TOTAL ETCH ADHESIVE DENTSPLY INTL.
K150535 03/03/2015 Cavitron Touch Ultrasonic Scaling System DENTSPLY INTERNATIONAL, INC.
K160626 03/07/2016 ATLANTIS Abutment for HIOSSEN ET implant DENTSPLY SIRONA
K110753 03/18/2011 MIDWEST RDH FREEDOM CORDLESS PROPHY SYSTEM DENTSPLY INTERNATIONAL, INC.
K170849 03/22/2017 SIMPLANT Guide Dentsply Sirona
K050750 03/23/2005 LC BRACKET ADHESIVE SYSTEM DENTSPLY INTL.
K160825 03/25/2016 MIDWEST RDH Freedom Cordless Prophy System with SmartMode Technology DENTSPLY SIRONA
K060837 03/28/2006 IN-OVATION C DENTSPLY INTERNATIONAL
K060836 03/28/2006 VISTADENT OC - VERSION 4 DENTSPLY INTL., INC.
K130862 03/28/2013 CAVITRON PROPHY-JET AIR POLISHING PROPHYLAXIS SYSTEM DENTSPLY INTL., INC.
K050880 04/06/2005 DYRACT EXTRA RESTORATIVE DENTSPLY INTL.
K161030 04/13/2016 ATLANTIS Abutment for CONELOG implant Dentsply Sirona
K050959 04/18/2005 DELTON ILLUMINATING PIT AND FISSURE SEALING DENTSPLY INTERNATIONAL
K151039 04/20/2015 ATLANTIS Abutment for NobelActive 3.0 DENTSPLY INTERNATIONAL, INC.
K161118 04/20/2016 SIMPLANT Online Case Review and SIMPLANT Editor DENTSPLY SIRONA
K161213 04/29/2016 XSmart iQ DENTSPLY SIRONA
K061264 05/05/2006 TEMPFX ESTHETIC PROVISIONAL SYSTEM DENTSPLY INTERNATIONAL, INC.
K161269 05/05/2016 CELTRA Press DENTSPLY SIRONA
K081291 05/07/2008 PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION DENTSPLY INTERNTIONAL
K161330 05/12/2016 Pour Acrylic Dentsply Sirona
K061427 05/23/2006 PRE-IMPRESSION CONDITIONING SOLUTION DENTSPLY INTL.
K151439 05/29/2015 ATLANTIS ISUS DENTSPLY INTERNATIONAL, INC.
K101493 06/01/2010 ADVANCED GLASS IONOMER (K-130) RESTORATIVE DENTSPLY INTERNATIONAL, INC.
K051462 06/03/2005 MODIFICATION TO: CERCON BASE DENTSPLY INTL.
K051463 06/03/2005 XENO ADHESIVE WITH ACTIVATOR DENTSPLY INTL.
K131644 06/05/2013 ANKYLOS SYNCONE ABUTMENT 5(DEGREE) DENTSPLY INTERNATIONAL, INC.
K061580 06/07/2006 ECLIPSE WAX REMOVER DENTSPLY INTERNATIONAL
K121698 06/08/2012 NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN DENTSPLY INTERNATIONAL INC.
K091706 06/10/2009 QUATTRO PORCELAIN SYSTEM DENTSPLY INTERNATIONAL, INC.
K151619 06/16/2015 Prime&Bond Elect Universal Dental Adhesive DENTSPLY INTERNATIONAL INC.
K131907 06/26/2013 RAYPEX 6 DENTSPLY INTERNATIONAL INC.
K051707 06/27/2005 ECLIPSE BONDING AGENT DENTSPLY INTL.
K071817 07/03/2007 OSTEOGRAF/N-300 DENTSPLY INTERNTIONAL
K092030 07/06/2009 ELATION MB METAL REINFORCED PLASTIC BRACKET DENTSPLY INTERNTIONAL
K132145 07/11/2013 MTM(R) CLEAR ALIGNER DENTSPLY INTERNATIONAL, INC.
K072056 07/26/2007 OSTEOGRAF/D-700 DENTSPLY INTERNATIONAL, INC.
K072057 07/26/2007 OSTEOGRAF/LD-300 DENTSPLY INTERNATIONAL, INC.
K072058 07/26/2007 MODIFICATION TO: OSTEOGRAF/N-700 DENTSPLY INTERNTIONAL
K072052 07/26/2007 OSTEOGRAF/D-300 DENTSPLY INTERNATIONAL, INC.
K112152 07/27/2011 CERCON HT DENTSPLY INTERNATIONAL, INC.
K162107 07/29/2016 TPH Spectra+ Universal Composite Restorative DENTSPLY SIRONA
K122268 07/30/2012 ANGLED XIVE MP ABUTMENT, ANGLED ANKYLOS DENTSPLY INTERNATIONAL
K122331 08/02/2012 CAVITY VARNISH DENTSPLY INTERNATIONAL, INC.
K052097 08/03/2005 CERAM X UNIVERSAL MANO-CERAMIC RESTORATIVE DENTSPLY INTERNATIONAL
K082198 08/04/2008 DURASHIELD PLUS DENTSPLY INTL., INC.
K142178 08/08/2014 PROROOT MTA WHITE, PROROOT MTA GRAY DENTSPLY INTERNATIONAL INC.
K122424 08/09/2012 ISUS IMPLANT SUPRASTRUCTURES DENTSPLY INTERNATIONAL, INC.
K152247 08/10/2015 ATLANTIS Crown DENTSPLY INTERNATIONAL, INC.
K072342 08/21/2007 SULTAN TOOTH ROOT DESENSITIZER DENTSPLY INTERNATIONAL, INC.
K052334 08/26/2005 CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131 DENTSPLY INTL.
K092614 08/26/2009 X-SMART EASY DENTSPLY INTERNTIONAL
K052370 08/30/2005 CP BRACKET SYSTEM DENTSPLY INTERNATIONAL
K072522 09/07/2007 THERMOFORM SHEET MATERIALS AND ACCESSORIES DENTSPLY INTERNATIONAL, INC.
K062828 09/20/2006 MOUTHGUARD AND ALIGNER MATERIALS DENTSPLY INTL., INC.
K072713 09/25/2007 ION DENTAL RESIN SYSTEM DENTSPLY INTERNATIONAL, INC.
K072730 09/26/2007 FRIADENT CERCON AND ANKYLOS CERCON BALANCE ABUTMENTS DENTSPLY INTL.
K152861 09/30/2015 Aquasil Ultra + Smart Wetting Impression Material DENTPLY INTERNATIONAL INC.
K082974 10/06/2008 MYSTIQUE MB CERAMIC BRACKETS DENTSPLY INTERNTIONAL
K082973 10/06/2008 STER-MATE STERILE LAVAGE KIT DENTSPLY INTERNTIONAL
K093221 10/13/2009 PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION II DENTSPLY INTL., INC.
K042905 10/21/2004 NEO-CLIP ORTHODONTIC BRACKET ACCESSORY DENTSPLY INTL.
K072989 10/23/2007 AXIS SYSTEM DENTSPLY INTL., INC.
K053010 10/26/2005 VISTADENT AT COMPLETE, MODEL 3.1 DENTSPLY INTL., INC.
K073067 10/30/2007 ANKYLOS DENTAL IMPLANT SYSTEM/CLAIMS DENTSPLY INTERNATIONAL, INC.
K073073 10/31/2007 ANKYLOS TEMPORARY ABUTMENT BALANCE DENTSPLY INTERNATIONAL, INC.
K073075 10/31/2007 FRIALIT PLUS, XIVE S PLUS, XIVE TG PLUS, ANKYLOS PLUS, DENTAL IMPLANT SYSTEMS DENTSPLY INTERNATIONAL, INC.
K103244 11/02/2010 QMIX 2IN1 ENDODONTIC IRRIGATING SOLUTION DENTSPLY INTL., INC.
K073117 11/05/2007 DENTIN DESENSITIZER AGENT DENTSPLY INTL., INC.
K163155 11/10/2016 MTM Clear Aligner DENTSPLY SIRONA
K083326 11/12/2008 FLUOROCORE 2 DENTSPLY INTERNATIONAL, INC.
K073173 11/13/2007 SELF-ADHESIVE RESIN CEMENT DENTSPLY INTERNTIONAL
K053167 11/14/2005 BIOPURE MTAD ROOT CANAL CLEANSER DENTSPLY INTL., INC.
K073218 11/15/2007 MTA ADVANCED MATERIAL DENTSPLY INTERNTIONAL
K113406 11/18/2011 AQUASIL ULTRA SMART WETTING IMPRESSION MATERIAL DENTSPLY INTERNATIONAL, INC.
K043247 11/23/2004 DUCERA ALLCERAM DENTSPLY INTL.
K123615 11/23/2012 IRIS - HIGH STRENGTH GLASS CERAMIC DENTSPLY INTL.
K053368 12/05/2005 INTERPROXIMAL REDUCTION SYSTEM DENTSPLY INTERNATIONAL
K103653 12/13/2010 E3 TORQUE CONTROL MOTOR DENTSPLY INTERNATIONAL INC.
K123925 12/20/2012 MTM CLEAR ALIGNER IN-OFFICE DENTSPLY INTERNATIONAL, INC.
K083805 12/22/2008 ANKYLOS C/X DENTAL IMPLANT SYSTEM DENTSPLY INTL., INC.
K083841 12/24/2008 ADAPTABLE COMPOSITE RESIN RESTORATIVE MATERIAL DENTSPLY INTERNATIONAL, INC.


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