510(k) Report

Devices descending from K962545

179 later devices reach Dental, Medical Instrument Cases & Cassette through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K182865Neodent Instruments KitsJjgc Industria E Comercio DE Materiais Dentarios S.A.201913—
+5K183199TRIO HandpieceOmniguide, Inc.20190—
+5K180915Sonicision Reusable Sterilization TrayCovidien20181—
+5K163600Kit Boxes and Kit PlatesNobel Biocare AB201818—
+5K170939Supplemental Instrument TraysNuvasive Specialized Orthopedics, Incorporated20170—
+5K163279Medtronic Transportation/Sterilization CassettesMedtronic Sofamor Danek USA, Inc.20174—
+5K140378Flexguide Ultra Beampath Robotic Fiber ConduitOmniguide, Inc.20142—
+5K140494V-Pro Sterilization Tray/ Sterilization MatSTERIS Corporation20147—
+5K133116Video Extended Length Tray (Plastic - Radel), Video Tray Single Level (Plastic - Radel)…Conmed Corporation20140—
+5K131170Sonicision Sterilization TrayCovidien, Formerly Valleylab, A Division of Tyco H20131—
+5K121904Gynecology Sterilization TraySmith & Nephew Inc., Endoscopy Division20130—
+5K123175Detachatip Iii Plus Instrument Tray Model 3-4343Conmed Corporation20130—
+5K120474Gyrus Acmi Telescope Storage-Sterilization TrayGyrus Acmi, Inc.20120—
+5K102544Smith & Nephew Hip Arthroscopy Repair Instrument TraySmith & Nephew Inc., Endoscopy Div.201101
+5K102103Skeletal Dynamics Sterilization TraysSkeletal Dynamics, LLC20104—
+6K252594UltraGuideCTR® image guided soft tissue release systemSonex Health20250—
+6K243425Guided DAS Surgical KitTalladium España, SL20250—
+6K243589PAL Sterilization CaseMicroaire Surgical Instruments, LLC20250—
+6K242762Aesculap Aicon® Series Container SystemAesculap, Inc.20250—
+6K250029ONE TRAY® Sealed Sterilization Container SystemInnovative Sterilization Technologies20250—
+6K243317NUVENTUS NV.C™ Surgical Cassette and TrayInfinitum Eta, Ltd.20250—
+6K242834System 9 Sterile Battery ContainerStryker Instruments20250—
+6K242417VECTR – Video Endoscopic Carpal Tunnel Release SystemRafael Medical Devices, LLC20240—
+6K230804Complement Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+6K203468TCAT TKA Instrument TrayTHINK Surgical, Inc.20210—
+6K212396UroLift System Rigid Retrieval Kit Sterilization TrayNeotract, Inc.20210—
+6K202268CrossRoads Tray SystemCrossroads Extremity Systems, LLC20203—
+6K202270EZ-TRAX Stryker Mako Total Knee with Triathlon Containment DeviceK1 Medical, LLC20202—
+6K201688S.I.N. Instrument KitsS.I.N. - Sistema DE Implante Nacional S.A.20204—
+6K193066Steripack cases and Tray SystemsAvalign Technologies, Inc.20200—
+6K192670Neodent Instrument Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A.20195—
+6K181075PureSet TrayNobel Biocare AB20185—
+6K180791Straumann BLX Surgical CassetteInstitut Straumann AG201811—
+6K173615Stryker Universal Select Sterilization Tray SystemParagon Medical20182—
+6K170777Bovie J-Plasma Precise FLEX HandpieceBovie Medical Corporation20171—
+6K160912Sterilization TraySTERIS Corporation20166—
+6K151347MIS Spine Frame Instrument CaseThompson Surgical Instruments20150—
+6K143579NuVasive Sterilization TraysNu Vasive, Incorporated20153—
+7K241927Synthes Graphic Case & Tray SystemSynthes GmbH20251—
+7K242564Autoclavable Cassette (Glidewell HT™ Implant Guided Surgical Kit, Glidewell HT™ Implant…Prismatik Dentalcraft, Inc.20250—
+7K241050CrossRoads Modular Tray SystemCrossroads Extremity Systems20240—
+7K241378S.I.N. Instrument KitsS.I.N. - Sistema DE Implante Nacional S.A.20240—
+7K231219NobelZygoma PureSet™ TrayNobel Biocare Services AG20230—
+7K223662Neodent Implant System - Helix Short Surgical Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+7K222514S.I.N. Instrument KitsS.I.N. – Sistema DE Implante Nacional S.A.20220—
+7K222005S.I.N. Instrument KitsS.I.N. - Sistema DE Implante Nacional S.A.20220—
+7K214051Neodent Implant System-Helix NGM Compact Surgical Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A.20220—
+7K212281Surgical TraysDentsply Sirona, Inc.20225—
+7K212932Nobel Biocare NobelSpeedy Groovy / Branemark System Mk III TiUnite / Replace Select TC…Nobel Biocare Services AG20212—
+7K212404S.I.N. Instrument KitsS.I.N. - Sistema DE Implante Nacional S.A.20211—
+7K203753Straumann Surgical CassettesStraumann USA, LLC20211—
+7K211007EZ-TRAXTM Persona Knee Containment DeviceK1 Medical, LLC20211—
+7K203618Neodent EasyGuide Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A.20211—
+7K201412BEGO SEMADOS Tr 58350; BEGO SEMADOS RS/RSX-Line Tray Plus, BEGO Semados Tr 58349; BEGO…Bego Implant Systems GmbH & Co. KG20210—
+7K202880J-Plasma Precise FLEX HandpieceApyx Medical Corporation (Formerly Bovie Medical Corporation20210—
+7K202515NUVO Implant System – NUVO Instrument Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+7K191522Straumann Modular CassetteInstitut Straumann AG20192—
+7K181845Pivot System Sterilization caseRp Medical, Inc.20190—
+7K191475Nobel Biocare N1 PureSet Tray, Nobel Biocare N1 PureSet Plate, Prosthetic PureSet Tray…Nobel Biocare AB20194—
+7K183701Stryker ChestShield Sterilization Tray SystemParagon Medical20190—
+7K173391OsteoMed QuickFix Hybrid MMF Sterilization TrayOsteomed, LLC20182—
+7K172755PRO-LITE Sterilization TraysSTERIS Corporation20185—
+8K260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AG20260—
+8K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.20260—
+8K241492Guided Surgery Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A.20240—
+8K231144WashtraysDentsply Sirona20240—
+8K233264Anthogyr INTEGRAL Guided Surgery CassettesAnthogyr20230—
+8K223672Instrument Case P1340904Cochlear20231—
+8K220791Surgical and Prosthetic TraysDentsply Sirona20222—
+8K213209EZ-TRAX Zimmer G7 Acetabular System / Taperloc Complete Hip System Containment DeviceK1 Medical, LLC20210—
+8K202105OsteoMed ExtremiFix Mini & Small System TrayOsteomed, LLC20200—
+8K183402PRO-LITE Sterilization TraySTERIS Corporation20193—
+8K183301PRO-LITE Sterilization TraySTERIS Corporation20190—
+9K261935Surgical and Prosthetic TraysDentsply Sirona, Inc.20260—
+9K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.20260—
+9K231604Instrument CaseCochlear Americas20230—
+9K222440Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization TraysSteris20222—
+10K231501PRO-LITE Sterilization TraySTERIS Corporation20230—
+10K231500Vis-U-All Low Temperature Sterilization PouchesSTERIS Corporation20230—