510(k) Report

Devices descending from K931767

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K231079LW Retraction CapOssvis Co., Ltd.20230—
+5K231557ZENEX FreeMilling & CCM Cast AbutmentIzenimplant Co., Ltd.20232—
+5K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+5K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+5K222976MU SystemDentis Co., Ltd.20230—
+5K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+5K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG20221—
+5K220482SherlockOpen Implants, LLC20221—
+5K220252High Retention Attachment SystemZest Anchors, LLC20221—
+5K212533BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) ImplantsInstitut Straumann AG20221—
+5K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+5K212538DESS Dental ImplantsTerrats Medical SL20211—
+5K212108Dynamic TiBaseTalladium España, SL20219—
+5K210903IS Multi Unit Abutment SystemNeobiotech Co., Ltd.20212—
+5K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+5K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+5K202942Straumann 4 mm Short ImplantsStraumann USA, LLC20210—
+5K201700BEGO Semados® RS/RSX Implant SystemBego Implant Systems GmbH & Co. KG20210—
+5K202344TiUltra Implants and Xeal AbutmentsNobel Biocare AB20204—
+5K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+5K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+5K191740DORO LUCENT® iXI and iMRI Headrest SystemPro Med Instruments GmbH20201—
+5K190552JJ Implant SystemJj Implants20190—
+5K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+5K182313BoneTrust Implant SystemMedical Instinct Deutschland GmbH20190—
+5K173418NobelParallel Conical ConnectionNobel Biocare AB201951
+5K181520Sirona Dental CAD/CAM SystemDentsply Sirona20186—
+5K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+5K171784Straumann Dental Implant SystemStraumann USA, LLC20184—
+5K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+5K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.2017306
+5K163557SS SA FixtureOsstem Implant Co., Ltd.20173—
+5K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+5K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+5K153015Transfer & Angled AbutmentOsstem Implant Co., Ltd.20168—
+5K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+5K153521IH Implant SystemSewonmedix, Inc.201610—
+5K161677Straumann Sterile Healing SolutionInstitut Straumann AG20160—
+5K1514553Shape Abutment Designer Software3Shape A/S201610—
+5K153645VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co.20160—
+5K153350IBS Implant SystemInnobiosurg Co., Ltd.20167—
+5K151984Thommen Milling Abutment for CAD/CAMThommen Medical AG20161—
+5K152555Dental Implant SystemAriabio International, Inc.20160—
+5K151621BioHorizons CAD/CAM AbutmentsBioHorizons Implant Systems, Inc.201626—
+5K142313OneQ-SL Implant SystemDentis Co., Ltd.201519—
+5K150388Dental Implant SystemBio Concept Co., Ltd.20151—
+5K151169OsteoReady ZircoSeal AbutmentsOsteoready, LLC20150—
+5K150296Biodenta Customized Abutment-HybridBiodenta Swiss AG20150—
+5K143326T.A.G. Dental Implant SystemT.A.G. Medical Products Corporation, Ltd.20151—
+5K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+5K133362SGS Dental ImplantSgs International, Ltd.20142—
+5K140934Hiossen Implant SystemHiossen, Inc.201413—
+5K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+5K140878Straumann Bone Level Tapered ImplantStraumann USA, LLC20141052
+5K131468Denracle Dental AbutmentGreen Dentech Co, Ltd.20140—
+5K130662ET Prosthetic SystemOsstem Implant Co., Ltd.2014424
+5K131165Anker Dental Implant SystemAlliance Global20131—
+5K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG201339—
+5K130408Era Micro 23 Female Abutment, Era Micro 30 Female AbutmentSterngold Dental, LLC20131—
+5K122804Royal-Dent Eureka Dental Implant SystemIntai Technology Corp.20130—
+5K121585TS Implant SystemOsstem Implant Co., Ltd.201364—
+5K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—
+5K121117NDX AbutmentsNational Dentex Corp20120—
+5K121995TS Fixture SystemOsstem Implant Co., Ltd.201224—
+5K113748Imris MR/X-Ray Head Fixation Device (HFD)Imris, Inc.201201
+5K110308Prosthetic SystemOsstem Implant Co., Ltd.2011105—
+5K103493Head Fiation Device (HFD 100)Imris, Inc.201123
+5K072208Mayfield Disposable and Reusable Titanium Skull PinsIntegra LifeSciences Corporation20074—
+6K261122Mist ICImagine Milling Technologies, LLC20260—
+6K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+6K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+6K252197Nobel Biocare S Series ImplantsNobel Biocare AB20260—
+6K250423mb-FIX Cranial Stabilization SystemsMedical Bees GmbH20250—
+6K251280DESS® Dental ImplantsTerrats Medical SL20250—
+6K250967SherlockOpen Implants, LLC20250—
+6K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+6K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+6K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+6K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+6K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+6K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+6K242686Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A.202421
+6K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+6K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+6K240319DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)Pro Med Instruments GmbH20240—
+6K232049IS-III active Short ImplantNeobiotech Co., Ltd.20240—
+6K231132J & P Click AttachmentsJ & P Dental Technologies20240—
+6K232268STERI-OSS Implant SystemZeros Co., Ltd.20241—
+6K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+6K233163ZENEX Implant System_ShortIzenimplant Co., Ltd.20231—
+6K231803Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20231—
+6K232418Single Platform SP1 Implant SystemSouthern Implants (Pty), Ltd.20232—
+6K222778Osstem Implant SystemOsstem Implant Co., Ltd.20232—
+6K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+6K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+6K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+6K221673Bonafix TiBaseZentek Medical, LLC20231—
+6K222707IH Implant SystemSewonmedix, Inc.20231—
+6K223638Neodent Implant System - Helix Short Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+6K223083Straumann SLActive labeling changesInstitut Straumann AG20230—