510(k) Report

Devices descending from K083805

290 later devices reach Ankylos C/X Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+3K203382Neodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A.202102
+3K202282Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+3K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+3K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+3K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—
+3K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+3K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+3K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+3K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+3K193335SherlockOpen Implants, LLC20203—
+3K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+3K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+3K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+3K191191Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+3K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+3K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+3K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+3K182246Mist ICImagine Milling Technologies, LLC20194—
+3K182228MIS LOCKiT Abutments System, OT-Equators and Ball AttachmentsMis Implants Technologies, Ltd.20190—
+3K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+3K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+3K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+3K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+3K180536Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20182—
+3K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+3K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+3K180609Rodo SmilekeyRodo Medical, Inc.20180—
+3K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+3K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+3K171757Straumann Screw Retained AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)201714—
+3K170394Kisses MiniAchimhai Medical Corporation20170—
+3K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona20169—
+3K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+3K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+3K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+3K152509CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)Altatec GmbH20160—
+3K151599iSy Implant SystemAltatec GmbH20150—
+3K151247NC Straumann Screw Retained AbutmentsStraumann USA, LLC20150—
+3K150814Straumann Screw-Retained AbutmentStraumann USA, LLC20150—
+3K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+3K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—
+3K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+3K140737Straumann Cares Screw Retained Bars/BridgeStraumann USA, LLC20140—
+3K141871Straumann Bone Level NC Angled Screw Retained AbutmentsStraumann USA, LLC20142—
+4K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+4K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+4K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+4K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+4K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+4K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+4K253341Custom Abutments ASMedentika GmbH20250—
+4K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+4K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+4K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K251647MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+…Dentsply Sirona, Inc.20250—
+4K251297MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc.20250—
+4K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+4K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+4K243824Preat AbutmentsPreat Corporation20250—
+4K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+4K232383iPhysio® SystemEuroteknika20250—
+4K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+4K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+4K233857Neodent Implant System – Custom AbutmentsJJGC Indústria e Comércio de Materiais Dentários S.A.20242—
+4K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+4K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+4K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+4K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+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—
+4K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+4K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+4K231559Multi-Unit DAS SystemTalladium España, SL20231—
+4K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+4K232151Dynamic TiBaseTalladium España, SL20232—
+4K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+4K222636ET Abutment SystemHiossen, Inc.20230—
+4K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+4K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+4K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+4K222368Mist ICImagine Milling Technologies, LLC20222—
+4K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+4K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+4K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+4K213391High Retention Attachment SystemZest Anchors, LLC20227—
+4K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+4K212664SherlockOpen Implants, LLC20212—
+4K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+4K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+4K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+4K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+4K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+4K191123Multi-unit AbutmentsMedentika GmbH202011—
+4K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+4K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—