510(k) Report

Devices descending from K002513

426 later devices reach Astra Tech Implants - Dental System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K1514553Shape Abutment Designer Software3Shape A/S201610—
+5K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona20169—
+5K153645VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co.20160—
+5K160244VARIOuniteThommen Medical AG201615—
+5K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+5K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+5K150388Dental Implant SystemBio Concept Co., Ltd.20151—
+5K151375Inclusive Titanium Abutments compatible with: Hiossen HG Implant SystemPrismatik Dentalcraft, Inc.20150—
+5K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+5K141970Digitek Titanium AbutmentDigitek Dental Solutions Limited20150—
+5K150295LOCATOR RTxZest Anchors, Inc.201542—
+5K150537MiNi Internal Implant SystemMegagen Implant Co., Ltd.20151—
+5K150296Biodenta Customized Abutment-HybridBiodenta Swiss AG20150—
+5K142167Medentika Abutment SystemMedentika GmbH20157—
+5K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+5K140878Straumann Bone Level Tapered ImplantStraumann USA, LLC20141052
+5K133991ISYAltatec GmbH20142—
+5K131468Denracle Dental AbutmentGreen Dentech Co, Ltd.20140—
+5K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG201339—
+5K130408Era Micro 23 Female Abutment, Era Micro 30 Female AbutmentSterngold Dental, LLC20131—
+5K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—
+5K121117NDX AbutmentsNational Dentex Corp20120—
+5K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc.201130—
+5K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc.2011451
+6K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+6K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+6K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+6K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+6K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+6K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+6K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+6K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+6K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+6K242686Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A.202421
+6K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+6K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+6K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+6K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+6K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+6K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+6K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+6K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+6K231803Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20231—
+6K232418Single Platform SP1 Implant SystemSouthern Implants (Pty), Ltd.20232—
+6K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+6K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+6K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+6K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+6K223638Neodent Implant System - Helix Short Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+6K223083Straumann SLActive labeling changesInstitut Straumann AG20230—
+6K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+6K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+6K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+6K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+6K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+6K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+6K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+6K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+6K220823Preat AbutmentsPreat Corporation202216
+6K221966Dynamic TiBaseTalladium Espana, SL20225—
+6K212364BLT Dental Implant SystemBio Concept Co., Ltd.20220—
+6K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+6K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+6K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+6K212538DESS Dental ImplantsTerrats Medical SL20211—
+6K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+6K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+6K203750Straumann CARES P-Series CAD/CAM SystemInstitut Straumann AG20210—
+6K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+6K193352AbutmentCADExocad GmbH20210—
+6K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+6K203456Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20210—
+6K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+6K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+6K203382Neodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A.202102
+6K202282Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+6K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+6K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+6K200100Abutment Design3Shape A/S20203—
+6K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+6K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—
+6K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+6K200191Sirona Dental CAD/CAM System with InLab SoftwareDentsply Sirona20200—
+6K193408Sirona Dental CAD/CAM System with CEREC Chairside SoftwareDentsply Sirona20202—
+6K191152MIS Ti-base AbutmentDentsply Sirona20201—
+6K193404UF (II) Bar holder abutmentDio Corporation20200—
+6K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+6K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+6K193335SherlockOpen Implants, LLC20203—
+6K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+6K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+6K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+6K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+6K191191Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+6K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+6K191382IPS e.max CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20193—
+6K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+6K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—