510(k) Report

Devices descending from K974738

543 later devices reach Astra Tech Implant Dental System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+5K222738Point implant systemPointnix Co., Ltd.20230—
+5K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+5K222976MU SystemDentis Co., Ltd.20230—
+5K212702IM/ST Fixture SystemGuilin Fiteeth Medical Instrument Co., Ltd.20221—
+5K220048NobelProcera Zirconia N1 BaseNobel Biocare Services AG20221—
+5K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+5K220482SherlockOpen Implants, LLC20221—
+5K220252High Retention Attachment SystemZest Anchors, LLC20221—
+5K220022TRATE Dental Implant SystemTrate AG20221—
+5K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+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—
+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—
+5K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+5K192274BV Dental Implant SystemBio Concept Co., Ltd.20200—
+5K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+5K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+5K200189Luna Dental Implant System- Healing AbutmentShinhung Mst Co., Ltd.20200—
+5K190552JJ Implant SystemJj Implants20190—
+5K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+5K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+5K182313BoneTrust Implant SystemMedical Instinct Deutschland GmbH20190—
+5K173418NobelParallel Conical ConnectionNobel Biocare AB201951
+5K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+5K181520Sirona Dental CAD/CAM SystemDentsply Sirona20186—
+5K172630Kisses Plus Implant SystemAchimhai Medical Corporation20180—
+5K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+5K171784Straumann Dental Implant SystemStraumann USA, LLC20184—
+5K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+5K171027Dentis Dental Implant SystemDentis Co., Ltd.20175—
+5K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.2017306
+5K170044Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant SystemPrismatik Dentalcraft, Inc.20175—
+5K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+5K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+5K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+5K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—
+5K153332ETIII SA Fixture System (O3.2mm)Hiossen, Inc.20160—
+5K153521IH Implant SystemSewonmedix, Inc.201610—
+5K161677Straumann Sterile Healing SolutionInstitut Straumann AG20160—
+5K1514553Shape Abutment Designer Software3Shape A/S201610—
+5K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+5K153645VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co.20160—
+5K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+5K153639OneQ-SL s-Clean Implant SystemDentis Co., Ltd.201614—
+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—
+5K142813Biogensis Implant System-KissesBiogenesis Co., Ltd.20151—
+5K150296Biodenta Customized Abutment-HybridBiodenta Swiss AG20150—
+5K141950HFD100 Rocker Arm AccessoryImris, Inc.20140—
+5K140507Hiossen Prosthetic SystemOsstem Implant Co., Ltd.201444—
+5K140878Straumann Bone Level Tapered ImplantStraumann USA, LLC20141052
+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—
+5K123627ET Smartfit AbutmentHiossen, Inc.201321—
+5K123755Multi Angled AbutmentOsstem Implant Co., Ltd.201347—
+5K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—
+5K121117NDX AbutmentsNational Dentex Corp20120—
+6K260463ZEROS Dental Implant SystemZeros Co., Ltd.20260—
+6K261122Mist ICImagine Milling Technologies, LLC20260—
+6K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+6K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+6K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+6K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+6K252197Nobel Biocare S Series ImplantsNobel Biocare AB20260—
+6K252286BIORES Dental Implant SystemChengdu Besmile Medical Technology Co., Ltd.20260—
+6K251280DESS® Dental ImplantsTerrats Medical SL20250—
+6K250280SD TL Implant SystemArum Dentistry Co., Ltd.20250—
+6K250967SherlockOpen Implants, LLC20250—
+6K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+6K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+6K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+6K241003HIOSSEN Pre-milled Abutment (ET Pre-milled Abutment & EK Pre-milled Abutment)Hiossen, Inc.20250—
+6K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+6K242753SD TL Implant SystemArum Dentistry Co., Ltd.20251—
+6K242686Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A.202421
+6K240143JDZygoma dental implantsJdentalcare Srl20240—
+6K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+6K233389EK Digital AbutmentsHiossen, Inc.20240—
+6K231132J & P Click AttachmentsJ & P Dental Technologies20240—
+6K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+6K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+6K231803Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20231—
+6K232418Single Platform SP1 Implant SystemSouthern Implants (Pty), Ltd.20232—
+6K231235LW UCLA AbutmentOssvis Co., Ltd.20230—
+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—