510(k) Report

Devices descending from K013067

568 later devices reach Frialoc Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+5K150363NOVA Dental Implants SystemNova Implants, Ltd.20150—
+5K150199Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20151—
+5K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—
+5K142890Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase…Straumann USA, LLC201530—
+5K141923Inclusive Titanium Abutments, Compatible with Dentsply Implants Ankylos C/XPrismatik Dentalcraft, Inc.20150—
+5K133362SGS Dental ImplantSgs International, Ltd.20142—
+5K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+5K141450AXIOM 2.8Anthogyr Sas201401
+5K140878Straumann Bone Level Tapered ImplantStraumann USA, LLC20141052
+5K133421Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal ScrewStraumann USA, LLC2014115—
+5K132144KeratorLK Consulting Group USA, Inc.20140—
+5K133696Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20144—
+5K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA2014123—
+5K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+5K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.201329—
+5K122988Klockner Dental Implant AbutmentsSoadco, S.L.20139—
+5K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2013127—
+5K113779Conelog Implant SystemAltatec GmbH201214—
+5K121334VarioecoThommen Medical AG201216—
+5K120530Dentin Dental Implants System: Rapid, Classic, Prestige, One Piece, Dentin Dental…Dentin Implants Technologies, Ltd.20120—
+5K120338Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in ZirconiaAstra Tech, Inc.2012197—
+5K112795Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.2012115
+5K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+5K103280Bhdental Implant SystemBhdental, Ltd.20110—
+5K101545Genesis Implant SystemKeystone Dental2010153
+5K082800Star/Vent Internal Hex Screw ImplantPark Dental Research Corp.20100—
+5K083550Straumann Dental Implant SystemStraumann USA2009228—
+5K081419Straumann Dental Implant SystemInstitut Straumann AG2009142—
+5K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp.20081411
+5K071803Ards Dental ImplantsArds, Ltd.200813—
+6K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+6K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.20260—
+6K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+6K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+6K252031Adin Long Dental Implant SystemAdin Dental Implant Systems, Ltd.20260—
+6K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+6K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+6K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+6K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K250271Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+6K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K250295Dentsply Sirona Titanium Bases systemDentsply Sirona20250—
+6K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+6K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+6K233252Straumann CARES Visual and Nova Dental CADInstitut Straumann AG20240—
+6K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+6K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+6K242686Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A.202421
+6K241692MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc.20242—
+6K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+6K240143JDZygoma dental implantsJdentalcare Srl20240—
+6K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+6K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+6K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+6K233285KATANA Zirconia ONE For IMPLANTKuraray Noritake Dental, Inc.20240—
+6K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+6K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+6K231529CloudPoint FastDesign ChairsidePrismatik Dentalcraft, Inc.20240—
+6K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+6K231072Anthogyr FlexiBase® titanium bases for Axiom® BLAnthogyr20240—
+6K231803Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20231—
+6K232418Single Platform SP1 Implant SystemSouthern Implants (Pty), Ltd.20232—
+6K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+6K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+6K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+6K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+6K221107TRUSTRgorithm Korea20230—
+6K222026Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+6K223638Neodent Implant System - Helix Short Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+6K223083Straumann SLActive labeling changesInstitut Straumann AG20230—
+6K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+6K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+6K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+6K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+6K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+6K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+6K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+6K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+6K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+6K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+6K220823Preat AbutmentsPreat Corporation202216
+6K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+6K221966Dynamic TiBaseTalladium Espana, SL20225—
+6K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+6K212364BLT Dental Implant SystemBio Concept Co., Ltd.20220—
+6K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+6K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+6K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+6K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+6K220022TRATE Dental Implant SystemTrate AG20221—
+6K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+6K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+6K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+6K212538DESS Dental ImplantsTerrats Medical SL20211—
+6K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+6K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+6K210336Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+6K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+6K211225MIS Ti-base abutmentDentsply Sirona20210—