510(k) Report

Devices descending from K111287

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+4K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+4K243824Preat AbutmentsPreat Corporation20250—
+4K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+4K232383iPhysio® SystemEuroteknika20250—
+4K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+4K231566ICX-Implant SystemMedentis Medical GmbH20240—
+4K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+4K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+4K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+4K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+4K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+4K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+4K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+4K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+4K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+4K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+4K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+4K231559Multi-Unit DAS SystemTalladium España, SL20231—
+4K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+4K232151Dynamic TiBaseTalladium España, SL20232—
+4K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+4K222636ET Abutment SystemHiossen, Inc.20230—
+4K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+4K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+4K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+4K222368Mist ICImagine Milling Technologies, LLC20222—
+4K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+4K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+4K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+4K213391High Retention Attachment SystemZest Anchors, LLC20227—
+4K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+4K212664SherlockOpen Implants, LLC20212—
+4K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+4K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+4K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+4K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+4K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+4K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+4K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+4K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+5K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+5K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+5K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+5K243732Multi-Unit DAS SystemTalladium España, SL20260—
+5K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+5K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+5K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+5K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+5K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+5K243009Mist ICImagine Milling Technologies, LLC20251—
+5K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+5K243530Dynamic TiBaseTalladium España, SL20250—
+5K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+5K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+5K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+5K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+5K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+5K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+5K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC20244—
+5K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+5K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+5K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+5K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+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—
+5K220482SherlockOpen Implants, LLC20221—
+5K220252High Retention Attachment SystemZest Anchors, LLC20221—
+5K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+5K212108Dynamic TiBaseTalladium España, SL20219—
+5K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+5K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+6K261122Mist ICImagine Milling Technologies, LLC20260—
+6K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+6K250967SherlockOpen Implants, LLC20250—
+6K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+6K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+6K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+6K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+6K231132J & P Click AttachmentsJ & P Dental Technologies20240—
+6K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+6K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+6K221673Bonafix TiBaseZentek Medical, LLC20231—
+6K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+7K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+7K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+7K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+7K250721LOCATOR® Angled AbutmentZest Anchors, LLC20252—
+7K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+7K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+7K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+8K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+8K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+8K252944LOCATOR® Angled AbutmentZest Anchors, LLC20251—
+8K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+9K260555LOCATOR® Angled AbutmentZest Anchors, LLC20260—
+9K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—