510(k) Report

Devices descending from K023631

307 later devices reach Astra Tech Dental Implants-Ceramic Abutments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+5K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+5K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+5K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+5K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+5K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+5K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+5K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+5K231559Multi-Unit DAS SystemTalladium España, SL20231—
+5K232151Dynamic TiBaseTalladium España, SL20232—
+5K231235LW UCLA AbutmentOssvis Co., Ltd.20230—
+5K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K222707IH Implant SystemSewonmedix, Inc.20231—
+5K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+5K222976MU SystemDentis Co., Ltd.20230—
+5K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+5K222368Mist ICImagine Milling Technologies, LLC20222—
+5K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+5K220440Dentis s-Clean Abutment MiniDentis Co., Ltd.20220—
+5K213391High Retention Attachment SystemZest Anchors, LLC20227—
+5K210039CORE1 Implant SystemCybermed, Inc.20220—
+5K212664SherlockOpen Implants, LLC20212—
+5K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+5K210080Dentis s-Clean s-Line MiniDentis Co., Ltd.20210—
+5K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+5K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+5K210134Dentis s-Clean s-LineDentis Co., Ltd.20212—
+5K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+5K200099s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20201—
+5K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+5K192688s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20203—
+5K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+5K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+5K171694s-Clean TiN Coating AbutmentsDentis Co., Ltd.20172—
+5K170220OneQ-SL s-Clean Implant SystemDentis Co., Ltd.20170—
+5K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+5K152559TruAbutment DSTruabutment201618—
+5K153350IBS Implant SystemInnobiosurg Co., Ltd.20167—
+5K132067Multi Angled Abutment SystemHiossen, Inc.201333—
+6K253493Dentis SQ-SL AXEL FixtureDentis Co., Ltd.20260—
+6K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+6K243732Multi-Unit DAS SystemTalladium España, SL20260—
+6K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+6K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+6K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+6K243009Mist ICImagine Milling Technologies, LLC20251—
+6K243530Dynamic TiBaseTalladium España, SL20250—
+6K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+6K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+6K240977DenQ Sub SLA Implant SystemDenq20240—
+6K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+6K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+6K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC20244—
+6K240511Dentis s-Clean SQ-SL FixtureDentis Co., Ltd.20240—
+6K230307Dentis i-Clean SystemDentis Co., Ltd.20230—
+6K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+6K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+6K220517IBS SystemInnobiosurg Co., Ltd.20220—
+6K220482SherlockOpen Implants, LLC20221—
+6K220252High Retention Attachment SystemZest Anchors, LLC20221—
+6K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+6K212108Dynamic TiBaseTalladium España, SL20219—
+6K202773s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20210—
+6K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+6K210132s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20210—
+6K202479IBS Implant SystemInnobiosurg Co., Ltd.20200—
+6K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+6K173120CCM Abutment SystemInnobiosurg Co., Ltd.20183—
+6K170259TruAbutment DSTruabutment201717—
+6K162099IBS Implant System IIInnobiosurg Co., Ltd.20175—
+7K261122Mist ICImagine Milling Technologies, LLC20260—
+7K250967SherlockOpen Implants, LLC20250—
+7K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+7K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+7K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+7K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+7K231132J & P Click AttachmentsJ & P Dental Technologies20240—
+7K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+7K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+7K221673Bonafix TiBaseZentek Medical, LLC20231—
+7K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+7K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+7K202418Magic UCLA Abutment SystemInnobiosurg Co., Ltd.20202—
+7K191913TruAbutment DSTruabutment, Inc.20200—
+7K200753IBS Implant System IIInnobiosurg Co., Ltd.20201—
+7K172304TruAbutment DSTruabutment, Inc.20188—
+8K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+8K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+8K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+8K250721LOCATOR® Angled AbutmentZest Anchors, LLC20252—
+8K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+8K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+8K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+8K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+8K201842TruBase STruabutment, Inc.20210—
+8K183106TruAbutment DSTruabutment, Inc.20207—
+9K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+9K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+9K252944LOCATOR® Angled AbutmentZest Anchors, LLC20251—