510(k) Report

Devices descending from K050258

511 later devices reach Groovy Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K223339Bone Chamber ImplantMegagen Implant Co., Ltd.20230—
+4K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+4K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+4K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+4K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+4K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+4K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+4K221381KDG AbutmentsKeystone Dental, Inc.20220—
+4K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+4K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+4K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+4K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+4K211109N1 TiUltra TCC Implant SystemNobel Biocare Services AG202122
+4K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+4K212538DESS Dental ImplantsTerrats Medical SL20211—
+4K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+4K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+4K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+4K203808Multi-unit Abutment, Multi-unit Angled AbutmentMegagen Implant Co., Ltd.20210—
+4K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+4K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+4K210161AnyOne Onestage Implant SystemMegagen Implant Co., Ltd.20210—
+4K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+4K200329IDCAM Dental ImplantsImplants Diffusion International20210—
+4K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+4K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+4K201700BEGO Semados® RS/RSX Implant SystemBego Implant Systems GmbH & Co. KG20210—
+4K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+4K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+4K200355Duranext AbutmentsElegant Dental Corp.20200—
+4K182081JDentalCare Implant System JDIconJdentalcare Srl20201—
+4K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+4K200188DSI Dental Implant SystemDsi Dental Solutions, Ltd.20200—
+4K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+4K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+4K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+4K190552JJ Implant SystemJj Implants20190—
+4K192347ST Internal Implant SystemMegagen Implant Co., Ltd.20190—
+4K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+4K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+4K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+4K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+4K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+4K182246Mist ICImagine Milling Technologies, LLC20194—
+4K183518Preat AbutmentsPreat Corporation2019223
+4K173418NobelParallel Conical ConnectionNobel Biocare AB201951
+4K182293OsseOne Dental Implant SystemSynoross Dba Osseone20195—
+4K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+4K181359InterActive SMARTBase AbutmentsImplant Direct Sybron Manufacturing, LLC20186—
+4K172430ArgenIS Titanium AbutmentsArgen Corporation20180—
+4K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+4K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+4K163349MIS V3 Conical Connection Dental Implant System­Mis Implants Technologies, Ltd.20178—
+4K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH20171—
+4K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+4K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+4K161435Temporary Snap AbutmentNobel Biocare AB201601
+4K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+4K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+4K153758Straumann Bone Level Tapered ImplantsInstitut Straumann AG20160—
+4K152555Dental Implant SystemAriabio International, Inc.20160—
+4K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+4K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+4K141970Digitek Titanium AbutmentDigitek Dental Solutions Limited20150—
+4K150938Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsStraumann USA, LLC201562
+4K143505Zimmer Patient-Specific Abutment, Internal Hex, TitaniumZimmer Dental, Inc.20158—
+4K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+4K141923Inclusive Titanium Abutments, Compatible with Dentsply Implants Ankylos C/XPrismatik Dentalcraft, Inc.20150—
+4K140440Noris Medical Dental Implants SystemNoris Medical, Ltd.201414—
+4K142118Inclusive Titanium Abutments Compatible with: Straumann Bone Level, Nobel Biocare BranaePrismatik Dentalcraft, Inc.20142—
+4K142115Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel Biocare ImplantPrismatik Dentalcraft, Inc.201421
+4K141211Inclusive Titanium Abutments Compatible with Straumann Tissue Level ImplantsPrismatik Dentalcraft, Inc.20141—
+4K141544Zimmer ZFX Titanium Abutment for Biomet 3I Certain Implant SystemZimmer Dental, Inc.201412—
+4K141450AXIOM 2.8Anthogyr Sas201401
+4K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+4K123861Aidi Dental Implant SystemAidi Biomedical, LLC20130—
+4K121873Avinent Dental Implant SystemAvinent Implant System S.L.20130—
+4K132258Zimmer Dental Trabecular Metal Implant SystemZimmer Dental, Inc.20130—
+4K130999Osseospeed Profile EVDentsply Implants Manufacturing GmbH201318—
+4K113738Creodent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20137—
+4K130462Paltop Narrow Implant, Paltop Short ImplantPaltop Advanced Dental Solutions, Ltd.201381
+4K131451Paltop Dental Implant - Sterile AccessoriesPaltop Advanced Dental Solutions, Ltd.20130—
+4K130787Quantum Dental Implant SystemQuantum Bioengineering, Ltd.20130—
+4K122559Biodenta Dental Implant System - AbutmentsBiodenta Swiss AG20130—
+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—
+4K123415Biodenta Dental Implant System- Bone Level TaperedBiodenta Swiss AG20132—
+4K122602Nobelprocera TI Abutment Camlog PlatformsNobel Biocare AB20130—
+4K113816GC Aadva Abutment- Zirconium-BO AC BH SVGC America, Inc.20130—
+4K120873Zimmer ZFX Abutment for Nobel Replace Implant SystemZimmer Dental, Inc.201216—
+4K120414Osseospeed PlusAstra Tech AB2012196—
+4K112279Quantum Dental Implant SystemQuantum Bioengineering, Ltd.20121—
+4K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+4K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant…Astra Tech, Inc.20120—
+4K111421Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH201254—
+4K112259Nobelactive 3.0 Goldadapt AbutmentsNobel Biocare AB20110—
+4K111287Astra Tech Implant SystemAstra Tech AB2011201—
+4K110548Osi O-Ball Abutment Head ImplantsJuell Dental20112—
+4K11158115 Esthetic Abutment Nobelactive 03.0 1.5MM, 15 Esthetic Abutment Nobelactive 03.0 3MM…Nobel Biocare AB20114—
+4K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH2010240—