510(k) Report

Devices descending from K160730

20 later devices reach Instrument kits through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230680Anthogyr Surgical CassettesAnthogyr20230—
+1K171713Neodent Instrument KitsJjgc Industria E Comercio DE Materiais Dentarios S.A.201818—
+2K201878ST-Z5Z-Systems AG20212—
+2K190665Neodent Instrument Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+2K182865Neodent Instruments KitsJjgc Industria E Comercio DE Materiais Dentarios S.A.201913—
+3K243425Guided DAS Surgical KitTalladium España, SL20250—
+3K243317NUVENTUS NV.C™ Surgical Cassette and TrayInfinitum Eta, Ltd.20250—
+3K230804Complement Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+3K212068Biotech Dental KitsBiotech Dental, Sas20210—
+3K201688S.I.N. Instrument KitsS.I.N. - Sistema DE Implante Nacional S.A.20204—
+3K192670Neodent Instrument Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A.20195—
+4K241378S.I.N. Instrument KitsS.I.N. - Sistema DE Implante Nacional S.A.20240—
+4K223662Neodent Implant System - Helix Short Surgical Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+4K222514S.I.N. Instrument KitsS.I.N. – Sistema DE Implante Nacional S.A.20220—
+4K222005S.I.N. Instrument KitsS.I.N. - Sistema DE Implante Nacional S.A.20220—
+4K214051Neodent Implant System-Helix NGM Compact Surgical Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A.20220—
+4K212404S.I.N. Instrument KitsS.I.N. - Sistema DE Implante Nacional S.A.20211—
+4K203618Neodent EasyGuide Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A.20211—
+4K202515NUVO Implant System – NUVO Instrument Kit CasesJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+5K241492Guided Surgery Kit CasesJJGC Indústria e Comércio de Materiais Dentários S.A.20240—