510(k) Report

Devices descending from K003226

400 later devices reach The Lifecore Stage-1 Single Stage RBM Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+4K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K233857Neodent Implant System – Custom AbutmentsJJGC Indústria e Comércio de Materiais Dentários S.A.20242—
+4K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+4K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+4K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+4K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+4K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+4K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+4K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+4K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+4K232220SS Abutment SystemOsstem Implant Co., Ltd.20230—
+4K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+4K222142BR SLA Type Implant SystemBiotem Co., Ltd.20230—
+4K222144IR SLA Type Implant SystemBiotem Co., Ltd.20230—
+4K222636ET Abutment SystemHiossen, Inc.20230—
+4K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+4K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+4K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+4K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+4K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+4K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+4K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+4K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+4K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+4K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+4K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+4K190837Internal Hex Implant SystemEbi, Inc.20200—
+4K191123Multi-unit AbutmentsMedentika GmbH202011—
+4K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+4K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+4K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+4K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+4K182246Mist ICImagine Milling Technologies, LLC20194—
+4K183518Preat AbutmentsPreat Corporation2019223
+4K181137IT-III active SystemNeobiotech Co., Ltd.20183—
+4K173141CSM Submerged3-L Implant SystemCsm Implant20180—
+4K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+4K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+4K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+4K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+4K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+4K153521IH Implant SystemSewonmedix, Inc.201610—
+4K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+4K152520Magicore SystemInnobiosurg Co., Ltd.20167—
+4K140507Hiossen Prosthetic SystemOsstem Implant Co., Ltd.201444—
+4K132956U Fit Dental Implant SystemT Strong, Inc.20141—
+4K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—
+4K122804Royal-Dent Eureka Dental Implant SystemIntai Technology Corp.20130—
+4K121843NP-Cast Abutment SystemOsstem Implant Co., Ltd.201254—
+4K120847ET/SS Implant SystemOsstem Implant Co., Ltd.201275—
+4K120043CSM Internal-R Implant SystemCsm Implant20121—
+4K110308Prosthetic SystemOsstem Implant Co., Ltd.2011105—
+4K103537ET Iii SA Ultra Wide SystemHiossen, Inc.201137—
+4K101890Ball Abutment SystemMegagen Co., Ltd.20110—
+4K100245HS/HG Prosthetic SystemOsstem Implant Co., Ltd.2010111—
+4K100511Cotec Dental Implant SystemCotec Implant Co., Ltd.20100—
+4K093889Modification to: HG Iii Ultra Wide SystemHiossen, Inc.201038—
+4K090054Atlas Implant System - Wide PlusCowellmedi Co., Ltd.20091—
+4K090825SQ IS SystemNeobiotech Co., Ltd.200955—
+4K082843Modificaton to: Dentis Dental Implant SystemDentis Co., Ltd.20091—
+4K083633HS II Short Fixture SystemOsstem Implant Co., Ltd.200976—
+4K081786Ziocera & Convertible SystemOsstem Implant Co., Ltd.2008123—
+4K080744HG II Fixture SystemOsstem Implant Co., Ltd.2008112—
+4K072896GS Fixture SystemOsstem Implant Co., Ltd.200715—
+5K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+5K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+5K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+5K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+5K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+5K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+5K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+5K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+5K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+5K250614Neodent Implant System - Custom AbutmentsJjgc Indústria E Comércia DE Materiais Dentários S.A.20251—
+5K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+5K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+5K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+5K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+5K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+5K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+5K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+5K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+5K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+5K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+5K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+5K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+5K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+5K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+5K231235LW UCLA AbutmentOssvis Co., Ltd.20230—
+5K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+5K222707IH Implant SystemSewonmedix, Inc.20231—
+5K222792SNUCONE Tissue Level Implant SystemSnucone Co., Ltd.20232—
+5K221752StellaShinhung Mst Co., Ltd.20230—
+5K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+5K223395Luna Dental Implant SystemShinhung Mst Co., Ltd.20230—
+5K222976MU SystemDentis Co., Ltd.20230—
+5K222984BioClean Implant Restorative SystemBioclean Dental, LLC20220—
+5K222368Mist ICImagine Milling Technologies, LLC20222—