510(k) Report

Devices descending from K935544

601 later devices reach 3I Standard Threaded/Self-Tapping Threaded Implants Modification through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K1221986.00MM X 6.00MM Macro External Implant SystemOco Biomedical20130—
+4K123512Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MMBiodenta Swiss AG20132—
+4K123870Xpeed Anyridge Internal Implant SystemMegagen Implant Co., Ltd.20131—
+4K123415Biodenta Dental Implant System- Bone Level TaperedBiodenta Swiss AG20132—
+4K120089Biogenesis Implant SystemBiogenesis Co., Ltd.20130—
+4K113042Revois Implant SystemRiemser Arzneimittel AG20130—
+4K121117NDX AbutmentsNational Dentex Corp20120—
+4K122052Minifix Ball Minifix OneBonafix Surgical and Dental Implants, LLC20120—
+4K121707Lew Mdi O-Ball Collared Implant,Park Dental Research Corp.20121—
+4K120043CSM Internal-R Implant SystemCsm Implant20121—
+4K110337Universal Maxillary MolarOco Biomedical20121—
+4K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant…Astra Tech, Inc.20120—
+4K110955Anyridge Internal Implant SystemMegagen Co., Ltd.201143—
+4K111199Intra-Lock Dental Implants with Blossom 3.4MM Implant Angled AbutmentsIntra-Lock International, Inc.20110—
+4K101005Astra Tech Implant System, New ComponentAstra Tech AB2011198—
+4K090081Talladium International Implantology AbutmentsTalladium Espana, SL20100—
+4K092857Vericore Abutment in Titanium for Implant SystemsWhip-Mix Corp.20100—
+4K092674Simpler Toadstool Mini ImplantPan Global Implant20090—
+4K090054Atlas Implant System - Wide PlusCowellmedi Co., Ltd.20091—
+4K081666Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra Osseospeed 3.0 ImplantsAstra Tech, Inc.2008337—
+4K073486Dentis Dental Implant SystemDentis Co., Ltd.200825—
+4K072917JJG Evolution Orthodontic Implant SystemOdontit S.A.20080—
+4K072241Primaconnex Cad/Cam Abutment SystemLifecore Biomedical, Inc.20077—
+4K071946Atlantis, Gemini and Gemini+ Abutments in Zirconia for Astra ImplantsAtlantis Components, Inc.2007209—
+4K070483Leone Monoimplant for O-Ring OverdentureLeone S.P.A.20070—
+5K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+5K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+5K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+5K252168Straumann® BLC Implants - Indication WideningInstitut Straumann AG20260—
+5K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+5K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+5K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+5K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+5K252090Pterygoid Indication for GM Helix ImplantsJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+5K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+5K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+5K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+5K243009Mist ICImagine Milling Technologies, LLC20251—
+5K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+5K243824Preat AbutmentsPreat Corporation20250—
+5K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+5K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+5K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+5K242261Accelx Implant SystemBiotech Dental, LLC20240—
+5K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+5K240143JDZygoma dental implantsJdentalcare Srl20240—
+5K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+5K240966Prima Plus Conical Implant SystemKeystone Dental, Inc.20240—
+5K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+5K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+5K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+5K233450MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary…Megagen Implant Co., Ltd.20241—
+5K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+5K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+5K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+5K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+5K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+5K231559Multi-Unit DAS SystemTalladium España, SL20231—
+5K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+5K232151Dynamic TiBaseTalladium España, SL20232—
+5K231827BTI Dental Implant System UnicCa® – Aesthetic Post AbutmentsB.T.I. Biotechnology Institute, Sl.20232—
+5K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+5K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+5K230873Angulated Screw Channel (ASC) Solution Abutments & SI-BASE AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K222636ET Abutment SystemHiossen, Inc.20230—
+5K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+5K222469TIB AbutmentsSouthern Implants (Pty), Ltd.20230—
+5K222913s-Clean Link AbutmentDentis Co., Ltd.20231—
+5K213677Bonafix 2 PlusZentek Medical, LLC20220—
+5K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+5K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+5K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+5K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+5K220022TRATE Dental Implant SystemTrate AG20221—
+5K213391High Retention Attachment SystemZest Anchors, LLC20227—
+5K210117Paltop Narrow ImplantPaltop Advanced Dental Solutions, Ltd.20215—
+5K212664SherlockOpen Implants, LLC20212—
+5K212108Dynamic TiBaseTalladium España, SL20219—
+5K210410s-Clean Pre-Milled Abutment MiniDentis Co., Ltd.20210—
+5K203344Premilled Titanium Block SystemInnobiosurg Co., Ltd.20210—
+5K210362s-Clean Pre-Milled AbutmentDentis Co., Ltd.20211—
+5K200386Z5-BLZ-Systems AG20200—
+5K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+5K182448AnyRidge Octa 1 Implant SystemMegagen Implant Co., Ltd.20199—
+5K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+5K190849IS-III active System_S-narrow TypeNeobiotech Co., Ltd.20191—
+5K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+5K170732Biomate Dental Implant SystemBiomate Medical Devices Technology Co., Ltd.20180—
+5K173141CSM Submerged3-L Implant SystemCsm Implant20180—
+5K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+5K171027Dentis Dental Implant SystemDentis Co., Ltd.20175—
+5K160221Implance Dental Implant System, Implance Dental Abutment SystemAgs Medikal Urunleri Ith. Ihr. Tic. Ltd. Sti.20163—
+5K161030ATLANTIS Abutment for CONELOG implantDentsply Sirona20160—
+5K160213s-Clean Tapered II RBM Implant SystemDentis Co., Ltd.20160—
+5K153639OneQ-SL s-Clean Implant SystemDentis Co., Ltd.201614—
+5K150040ImplanovaDental Evolutions, Inc.20150—
+5K150344Dentis Dental Implant SystemDentis Co., Ltd.201520—
+5K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+5K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—