510(k) Report

Devices descending from K053384

528 later devices reach Fixature Microthread Osseospeed, a Component of the Astra Tech Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K222368Mist ICImagine Milling Technologies, LLC20222—
+4K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+4K220823Preat AbutmentsPreat Corporation202216
+4K212702IM/ST Fixture SystemGuilin Fiteeth Medical Instrument Co., Ltd.20221—
+4K221966Dynamic TiBaseTalladium Espana, SL20225—
+4K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+4K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+4K220022TRATE Dental Implant SystemTrate AG20221—
+4K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+4K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+4K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+4K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+4K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+4K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+4K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+4K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH20209—
+4K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+4K192274BV Dental Implant SystemBio Concept Co., Ltd.20200—
+4K193404UF (II) Bar holder abutmentDio Corporation20200—
+4K193078MIS CONNECT Conical Connection SystemDentsply Sirona20200—
+4K193335SherlockOpen Implants, LLC20203—
+4K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+4K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+4K191123Multi-unit AbutmentsMedentika GmbH202011—
+4K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+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—
+4K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+4K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+4K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+4K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+4K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+4K181520Sirona Dental CAD/CAM SystemDentsply Sirona20186—
+4K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+4K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+4K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+4K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+4K180609Rodo SmilekeyRodo Medical, Inc.20180—
+4K172100URIS OMNI SystemTruabutment, Inc.20187—
+4K172630Kisses Plus Implant SystemAchimhai Medical Corporation20180—
+4K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+4K171649Straumann CARES M-Series CAD/CAM SystemInstitut Straumann AG20183—
+4K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+4K170394Kisses MiniAchimhai Medical Corporation20170—
+4K170044Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant SystemPrismatik Dentalcraft, Inc.20175—
+4K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+4K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+4K153521IH Implant SystemSewonmedix, Inc.201610—
+4K1514553Shape Abutment Designer Software3Shape A/S201610—
+4K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+4K153645VITA ENAMIC Implant Solutions (IS)Vita Zahnfabrik H.Rauter GmbH Co.20160—
+4K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+4K153779Abutment for BridgesAltatec GmbH20161—
+4K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+4K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+4K151375Inclusive Titanium Abutments compatible with: Hiossen HG Implant SystemPrismatik Dentalcraft, Inc.20150—
+4K151599iSy Implant SystemAltatec GmbH20150—
+4K141970Digitek Titanium AbutmentDigitek Dental Solutions Limited20150—
+4K142813Biogensis Implant System-KissesBiogenesis Co., Ltd.20151—
+4K150296Biodenta Customized Abutment-HybridBiodenta Swiss AG20150—
+4K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+4K140934Hiossen Implant SystemHiossen, Inc.201413—
+4K131468Denracle Dental AbutmentGreen Dentech Co, Ltd.20140—
+4K131165Anker Dental Implant SystemAlliance Global20131—
+4K132209Ips E.Max Cad Abutment SolutionsIvoclar Vivadent, AG201339—
+4K122804Royal-Dent Eureka Dental Implant SystemIntai Technology Corp.20130—
+4K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—
+4K121117NDX AbutmentsNational Dentex Corp20120—
+4K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc.201130—
+4K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc.2011451
+4K101096HT Iii SA Fixture SystemHiossen, Inc.2010104—
+5K260463ZEROS Dental Implant SystemZeros Co., Ltd.20260—
+5K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+5K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+5K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+5K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+5K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+5K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+5K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+5K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+5K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+5K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+5K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K251647MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+…Dentsply Sirona, Inc.20250—
+5K251297MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc.20250—
+5K250280SD TL Implant SystemArum Dentistry Co., Ltd.20250—
+5K243009Mist ICImagine Milling Technologies, LLC20251—
+5K250614Neodent Implant System - Custom AbutmentsJjgc Indústria E Comércia DE Materiais Dentários S.A.20251—
+5K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+5K243824Preat AbutmentsPreat Corporation20250—
+5K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+5K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+5K242753SD TL Implant SystemArum Dentistry Co., Ltd.20251—
+5K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+5K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+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—
+5K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+5K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+5K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—