510(k) Report

Devices descending from K063286

211 later devices reach Osseotite; Osseotite NT; XP; TG Osseotite through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+3K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+3K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+3K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+3K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+3K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+3K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+3K193335SherlockOpen Implants, LLC20203—
+3K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+3K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+3K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+3K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+3K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+3K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+3K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+3K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+3K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+3K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+3K180609Rodo SmilekeyRodo Medical, Inc.20180—
+3K170394Kisses MiniAchimhai Medical Corporation20170—
+3K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona20169—
+3K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+3K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+3K151599iSy Implant SystemAltatec GmbH20150—
+3K143337CONELOG Titanium base CAD/CAMAltatec GmbH20150—
+4K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+4K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+4K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+4K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+4K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+4K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+4K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+4K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+4K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+4K251660T3 Pro Implants– ZimVie Packaging SystemBiomet 3i, LLC20250—
+4K243009Mist ICImagine Milling Technologies, LLC20251—
+4K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+4K243824Preat AbutmentsPreat Corporation20250—
+4K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+4K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+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—
+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—
+4K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+4K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+4K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+4K222636ET Abutment SystemHiossen, Inc.20230—
+4K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+4K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+4K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+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—
+4K212108Dynamic TiBaseTalladium España, SL20219—
+4K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+4K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+4K172225Atlantis Abutment for MIS ImplantDentsply Sirona20178—
+4K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+5K261122Mist ICImagine Milling Technologies, LLC20260—
+5K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+5K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+5K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+5K243732Multi-Unit DAS SystemTalladium España, SL20260—
+5K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+5K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+5K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+5K243530Dynamic TiBaseTalladium España, SL20250—
+5K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+5K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+5K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+5K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+5K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+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—
+5K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+5K221673Bonafix TiBaseZentek Medical, LLC20231—
+5K222976MU SystemDentis Co., Ltd.20230—
+5K220482SherlockOpen Implants, LLC20221—
+5K220252High Retention Attachment SystemZest Anchors, LLC20221—
+5K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+5K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+6K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+6K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+6K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+6K250967SherlockOpen Implants, LLC20250—
+6K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+6K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—