FDA 510(k) Applications Submitted by Karl J. Nittinger

FDA 510(k) Number Submission Date Device Name Applicant
K190043 01/09/2019 Halley resin Dentsply Sirona
K200102 01/17/2020 MIS Dental Implant System Dentsply Sirona
K230278 02/01/2023 Babyroo TN300 Draeger Medical Systems, Inc.
K170487 02/17/2017 Navina Classic System Dentsply Sirona
K171115 04/14/2017 3D Endo Software Dentsply Sirona
K190977 04/15/2019 Navina Smart System, Navina Classic System Dentsply Sirona
K191152 05/01/2019 MIS Ti-base Abutment Dentsply Sirona
K181189 05/03/2018 ATLANTIS Conus Structure Dentsply Sirona
K191427 05/29/2019 Halley resin system Dentsply Sirona
K181476 06/05/2018 Prime&Bond active Universal Adhesive Dentsply Sirona
K191616 06/18/2019 Orthophos S Dentsply Sirona
K191806 07/05/2019 Propex IQ Apex Locator Dentsply Sirona
K191865 07/12/2019 SmartLite Pro Modular LED Curing Light Dentsply Sirona
K172225 07/25/2017 Atlantis Abutment for MIS Implant Dentsply Sirona
K172239 07/26/2017 SIMPLANT 18 Dentsply Sirona
K182288 08/23/2018 TPH Spectra ST Flowable Composite Restorative Dentsply Sirona
K192409 09/04/2019 Midwest Rhino XE and Air Motor M Dentsply Sirona
K182422 09/06/2018 Lucitone Denture Base Materials Dentsply Sirona
K202629 09/11/2020 Dentsply Sirona Universal Spray Glazes Dentsply Sirona
K192530 09/16/2019 Surefil one Self-adhesive Composite Hybrid Dentsply Sirona
K162888 10/17/2016 Cercon Dentsply Sirona
K193064 11/04/2019 Atlantis suprastructures Dentsply Sirona Inc.
K183079 11/05/2018 Conometric Abutments Dentsply Sirona Inc.
K193078 11/05/2019 MIS CONNECT Conical Connection System Dentsply Sirona
K163350 11/30/2016 Multibase Abutments EV and ATLANTIS Suprastructures DENTSPLY SIRONA
K163398 12/05/2016 ATLANTIS suprastructures Dentsply Sirona
K193408 12/09/2019 Sirona Dental CAD/CAM System with CEREC Chairside Software Dentsply Sirona
K193405 12/09/2019 Simplant Digital Guide Dentsply Sirona
K193529 12/20/2019 ATLANTIS Abutment for MIS Conical Connection Implants Dentsply Sirona
K090047 01/07/2009 SYNTHES (USA) 1.5MM MINI FRAGMENT LCP SYSTEM SYNTHES (USA)
K180044 01/08/2018 SIROLaser Blue Dentsply Sirona
K150109 01/20/2015 Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology Arrow International ( a subsidiary of Teleflex, Inc.)
K210610 03/01/2021 PrimeTaper EV Dental Implant Dentsply Sirona, Inc.
K100676 03/10/2010 SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALL SYNTHES (USA)
K100776 03/18/2010 SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM SYNTHES (USA)
K210886 03/25/2021 MIS Lance+ Conical Connection Dental Implant System Dentsply Sirona
K090949 04/03/2009 SYNTHES (USA) 1.5MM HEADLESS COMPRESSION SCREWS SYNTHES (USA)
K081071 04/15/2008 SYNTHES 6.5MM MIDFOOT FUSION BOLT SYNTHES (USA)
K071111 04/20/2007 NON-ABSORBABLE SILK SUTURE ARROW INTL., INC.
K081205 04/29/2008 SYNTHES (USA) 5.0MM/7.3MM CRIMP POSITIONING PINS SYNTHES (USA)
K081353 05/14/2008 SYNTHES (USA) TOMOFIX MEDIAL DISTAL FEMUR PLATES SYNTHES (USA)
K071491 05/30/2007 ARROW INTERNATIONAL, INC., SURGICAL DRAPES ARROW INTL., INC.
K091644 06/04/2009 SYNTHES (USA) 2.4MM LCP VOLAR COLUMN DISTAL RADIUS PLATES SYNTHES (USA)
K082072 07/22/2008 SYNTHES (USA) 3.5MM LCP HOOK PLATE SYNTHES (USA)
K092556 08/20/2009 SYNTHES (USA) 2.4MM VA-LCP TWO-COLUMN NARROW VOLAR DISTAL RADIUS SYNTHES (USA)
K092646 08/28/2009 SYNTHES (USA) TROCHANTERIC FIXATION NAIL (TFN) SCREW SYNTHES (USA)
K082625 09/09/2008 SYNTHES (USA) 3.5MM LCP PERIARTICULAR PROXIMAL HUMERUS PLATES SYNTHES (USA)
K082624 09/09/2008 SYNTHES (USA) 3.5MM LCP POSTEROMEDIAL PROXIMAL TIBIA PLATES SYNTHES (USA)
K092812 09/14/2009 SYNTHES (USA) 2.7MM/ 3.5MM LCP ANTEROLATERAL DISTAL TIBIA PLATES SYNTHES (USA)
K103002 10/08/2010 SYNTHES MULTILOC PROXIMAL HUMERAL NAILING SYSTEM SYNTHES (USA)
K073186 11/13/2007 SYNTHES 3.5MM LCP CLAVICLE PLATE SYSTEM SYNTHES (USA)
K083573 12/03/2008 SYNTHES (USA) 3.5MM LOCKING ATTACHMENT PLATES SYNTHES (USA)
K073402 12/04/2007 SYNTHES OLECRANON OSTEOTOMY NAILING SYSTEM SYNTHES (USA)
K093928 12/22/2009 SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES SYNTHES (USA)
K190059 01/11/2019 CEREC Guides Dentsply Sirona
K200191 01/27/2020 Sirona Dental CAD/CAM System with InLab Software Dentsply Sirona
K170500 02/21/2017 SIROLaser Advance+ Dentsply Sirona
K160925 04/04/2016 VPS Rhythm Device with TipTracker Technology ARROW INTERNATIONAL, INC. (A SUBSIDIARY OF TELEFLEX, INC.)
K171122 04/17/2017 CEREC Ortho Software Dentsply Sirona
K201140 04/29/2020 Axeos Dentsply Sirona
K181520 06/11/2018 Sirona Dental CAD/CAM System Dentsply Sirona
K192149 08/09/2019 MIS Dental Implant System Dentsply Sirona Inc.


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