510(k) Report

Devices descending from K023658

43 later devices reach Sterilization Cases and Trays through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052992Conmed Linvatec Instrument Sterilization TrayConmed Linvatec200642—
+2K142519InterActive Complete Surgical TrayImplant Direct Sybron Manufacturing, LLC201530—
+2K070769VHP 136 TraySTERIS Corporation200710—
+3K210923Southern Implants Instrument TraysSouthern Implants (Pty), Ltd.20220—
+3K200858Mini Sterilizable TrayImplant Direct Sybron Manufacturing, LLC202031
+3K191566Avinent Surgical TrayAvinent Implant System S.L.U.20202—
+3K173642Klockner Surgical BoxSoadco, S.L.20181—
+3K160730Instrument kitsAnthogyr201720—
+3K140494V-Pro Sterilization Tray/ Sterilization MatSTERIS Corporation20147—
+3K131170Sonicision Sterilization TrayCovidien, Formerly Valleylab, A Division of Tyco H20131—
+4K243128Klockner KitsSoadco, S.L.20240—
+4K230680Anthogyr Surgical CassettesAnthogyr20230—
+4K212068Biotech Dental KitsBiotech Dental, Sas20210—
+4K201533Avinent Biomimetic Coral and Ocean-Iceberg Sterilization CassettesAvinent Implant System S.L.U.20210—
+4K202524Standard Sterilizable TrayImplant Direct Sybron Manufacturing, LLC20212—
+4K171713Neodent Instrument KitsJjgc Industria E Comercio DE Materiais Dentarios S.A.201818—
+4K160912Sterilization TraySTERIS Corporation20166—
+4K151347MIS Spine Frame Instrument CaseThompson Surgical Instruments20150—
+5K253988LiteSet TraysNobel Biocare AB20260—
+5K251756Sterilization TraysParagon Implant Mfg., LLC20250—
+5K201878ST-Z5Z-Systems AG20212—
+5K190665Neodent Instrument Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+5K182865Neodent Instruments KitsJjgc Industria E Comercio DE Materiais Dentarios S.A.201913—
+5K172755PRO-LITE Sterilization TraysSTERIS Corporation20185—
+6K243425Guided DAS Surgical KitTalladium España, SL20250—
+6K243317NUVENTUS NV.C™ Surgical Cassette and TrayInfinitum Eta, Ltd.20250—
+6K230804Complement Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+6K201688S.I.N. Instrument KitsS.I.N. - Sistema DE Implante Nacional S.A.20204—
+6K192670Neodent Instrument Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A.20195—
+6K183402PRO-LITE Sterilization TraySTERIS Corporation20193—
+6K183301PRO-LITE Sterilization TraySTERIS Corporation20190—
+7K241378S.I.N. Instrument KitsS.I.N. - Sistema DE Implante Nacional S.A.20240—
+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—
+7K222440Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization TraysSteris20222—
+7K214051Neodent Implant System-Helix NGM Compact Surgical Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A.20220—
+7K212404S.I.N. Instrument KitsS.I.N. - Sistema DE Implante Nacional S.A.20211—
+7K203618Neodent EasyGuide Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A.20211—
+7K202515NUVO Implant System – NUVO Instrument Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+8K241492Guided Surgery Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A.20240—
+8K231501PRO-LITE Sterilization TraySTERIS Corporation20230—
+8K231500Vis-U-All Low Temperature Sterilization PouchesSTERIS Corporation20230—