510(k) Report

Devices descending from K953101

104 later devices reach Paragon Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K113753Zimmer Dental Tapered Screw-Vent XZimmer Dental, Inc.20121—
+1K112787KeratorKj Meditech Co., Ltd.20123—
+1K112160Tapered Screw-Vent X ImplantZimmer Dental, Inc.20118819
+1K111852Anodized Healing CollarZimmer Dental, Inc.20111—
+1K101880Tapered Screw-Vent T Implant, Tapered Screw-Vent P ImplantZimmer Dental, Inc.2010941
+1K090723Hex-Lock Short Abutment, Model SA341, SA342, SA451, SA452, SA561, SA562 Short Healing…Zimmer Dental, Inc.20091—
+1K014175Sulzer Dental Ceramic System-HexlockSulzer Dental, Inc.20020—
+2K241183ISO AbutmentSeum Medi Co., Ltd.20250—
+2K173141CSM Submerged3-L Implant SystemCsm Implant20180—
+2K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+2K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+2K151916TRI Dental Implant SystemTri Dental Implants Int. AG20154—
+2K142082Zimmer 3.1MM Dental Implant;2.9MM Angled Abutment;Straight Hex, 2.9MM Contour AbutementZimmer Dental, Inc.20140—
+2K132144KeratorLK Consulting Group USA, Inc.20140—
+2K132258Zimmer Dental Trabecular Metal Implant SystemZimmer Dental, Inc.20130—
+2K113092Zimmer Contour Provisional CopingZimmer Dental, Inc.20120—
+3K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+3K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+3K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+3K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+3K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+3K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+3K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+3K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+3K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+3K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+3K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+3K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+3K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+3K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+3K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+3K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+3K182246Mist ICImagine Milling Technologies, LLC20194—
+3K183518Preat AbutmentsPreat Corporation2019223
+4K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+4K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+4K232383iPhysio® SystemEuroteknika20250—
+4K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+4K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+4K231566ICX-Implant SystemMedentis Medical GmbH20240—
+4K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+4K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+4K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+4K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+4K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+4K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+4K222368Mist ICImagine Milling Technologies, LLC20222—
+4K220823Preat AbutmentsPreat Corporation202216
+4K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+4K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+4K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+4K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+4K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+4K193335SherlockOpen Implants, LLC20203—
+4K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+5K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+5K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+5K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+5K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+5K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+5K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+5K243009Mist ICImagine Milling Technologies, LLC20251—
+5K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+5K243824Preat AbutmentsPreat Corporation20250—
+5K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+5K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+5K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+5K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+5K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+5K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+5K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+5K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+5K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+5K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+5K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+5K212664SherlockOpen Implants, LLC20212—
+5K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+5K212108Dynamic TiBaseTalladium España, SL20219—
+6K261122Mist ICImagine Milling Technologies, LLC20260—
+6K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+6K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+6K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+6K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+6K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+6K221673Bonafix TiBaseZentek Medical, LLC20231—
+6K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+6K221966Dynamic TiBaseTalladium Espana, SL20225—
+6K220482SherlockOpen Implants, LLC20221—
+7K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+7K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+7K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+7K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+7K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+7K250967SherlockOpen Implants, LLC20250—
+7K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+7K231559Multi-Unit DAS SystemTalladium España, SL20231—
+7K232151Dynamic TiBaseTalladium España, SL20232—