510(k) Report

Devices descending from K972351

548 later devices reach Sendax Mdi (Mini Dental Implant) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K151909Noris Medical Zygomatic Dental Implant SystemNoris Medical, Ltd.20167—
+5K141777Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20158—
+5K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+5K150199Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20151—
+5K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—
+5K142426EBI External Implant SystemEbi, Inc.20150—
+5K142167Medentika Abutment SystemMedentika GmbH20157—
+5K133733WINSIX Implant SystemBiosaf IN S.R.L.20150—
+5K140934Hiossen Implant SystemHiossen, Inc.201413—
+5K141544Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc.201412—
+5K141450AXIOM 2.8Anthogyr Sas201401
+5K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc.2014109—
+5K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—
+5K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+5K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+5K131066Axiom RegAnthogyr Sas20142—
+5K1330493I T3(R) External Hex Dental ImplantsBiomet 3i201419—
+5K122988Klockner Dental Implant AbutmentsSoadco, S.L.20139—
+5K122664Zuga Dental Implant SystemZuga Medical, Inc.20131—
+5K123512Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MMBiodenta Swiss AG20132—
+5K123415Biodenta Dental Implant System- Bone Level TaperedBiodenta Swiss AG20132—
+5K113779Conelog Implant SystemAltatec GmbH201214—
+5K122171MS SA Implant SystemOsstem Implant Co., Ltd.20122—
+5K112532ET II Bio-SA Fixture SystemHiossen, Inc.201210—
+5K120414Osseospeed PlusAstra Tech AB2012196—
+5K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant…Astra Tech, Inc.20120—
+5K111216Osseotite 2 Dental ImplantsBiomet 3i, Inc.201121—
+5K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc.201130—
+5K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc.2011451
+5K110778Biodenta Customized AbutmentBiodenta Swiss AG20112—
+5K103194Intra-Lock Dental Implants with BlossomIntra-Lock International, Inc.20115—
+5K110259Architex Space Maintenance SystemMedtronic Sofamor Danek USA, Inc.20111—
+5K103339TDS Abutment for Friadent XivePou YU Biotechnology Co., Ltd.20113—
+5K101225Promimic Dental Implant, 3.75 MM, Length 8.5 MM Model 03-1001, Promimic Dental Implant…Promimic AB201118—
+5K102822Implant-One SystemCustom Dental Implants, Inc.20113—
+5K100779Sustain Space Maintenance SystemMedtronic Sofamor Danek USA, Inc.20102—
+5K090476Syntec Orthodontic Mini ScrewSyntec Scientific Corp.200913—
+5K083480Inclusive Zirconia Abutment BlanksInclusive Dental Solutions200927—
+5K083141Simpact Endosseous Dental Implant SystemSimpact, LLC20080—
+5K073217Inclusive Implant AbutmentsInclusive Dental Solutions20083—
+5K072595Omni-TightBasic Dental Implant Systems, Inc.20081—
+5K061629Certain Prevail Dental ImplantImplant Innovations, Inc.20074—
+6K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+6K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+6K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+6K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+6K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+6K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+6K252731Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental ImplantPromimic AB20260—
+6K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+6K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+6K252286BIORES Dental Implant SystemChengdu Besmile Medical Technology Co., Ltd.20260—
+6K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+6K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+6K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+6K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+6K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K251148JDEvolution Plus L and JDEvolution Plus LEJdentalcare Srl20250—
+6K251660T3 Pro Implants– ZimVie Packaging SystemBiomet 3i, LLC20250—
+6K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+6K232383iPhysio® SystemEuroteknika20250—
+6K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+6K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+6K240383Highness Implant SystemHighness Co., Ltd.20240—
+6K241753Immediate Molar ImplantsBiomet 3i, LLC20240—
+6K240143JDZygoma dental implantsJdentalcare Srl20240—
+6K231502Mini ScrewsProimtech Saglik Urunleri Anonim Sirketi20240—
+6K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+6K240966Prima Plus Conical Implant SystemKeystone Dental, Inc.20240—
+6K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+6K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+6K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+6K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+6K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+6K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+6K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+6K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+6K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+6K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+6K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+6K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+6K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+6K223339Bone Chamber ImplantMegagen Implant Co., Ltd.20230—
+6K222636ET Abutment SystemHiossen, Inc.20230—
+6K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+6K221910QRS Dental Implants SystemQrs Medical, Ltd.20220—
+6K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+6K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+6K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+6K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+6K211872PiezoImplant SystemRex Implants, Inc.20220—
+6K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+6K220440Dentis s-Clean Abutment MiniDentis Co., Ltd.20220—
+6K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+6K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+6K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+6K213599SuperLineDentium Co., Ltd.20220—
+6K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+6K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+6K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—