510(k) Report

Devices descending from K994376

665 later devices reach Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+5K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+5K253341Custom Abutments ASMedentika GmbH20250—
+5K252582Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium®…Prismatik Dentalcraft, Inc.20250—
+5K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+5K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K251148JDEvolution Plus L and JDEvolution Plus LEJdentalcare Srl20250—
+5K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K251660T3 Pro Implants– ZimVie Packaging SystemBiomet 3i, LLC20250—
+5K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+5K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+5K232383iPhysio® SystemEuroteknika20250—
+5K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+5K241753Immediate Molar ImplantsBiomet 3i, LLC20240—
+5K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+5K240240Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent®…Prismatik Dentalcraft, Inc.20240—
+5K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+5K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+5K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+5K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+5K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+5K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+5K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+5K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+5K232750BTI Interna Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20230—
+5K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+5K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+5K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+5K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+5K223083Straumann SLActive labeling changesInstitut Straumann AG20230—
+5K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+5K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+5K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+5K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+5K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+5K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+5K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+5K221910QRS Dental Implants SystemQrs Medical, Ltd.20220—
+5K222368Mist ICImagine Milling Technologies, LLC20222—
+5K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+5K220823Preat AbutmentsPreat Corporation202216
+5K221966Dynamic TiBaseTalladium Espana, SL20225—
+5K212364BLT Dental Implant SystemBio Concept Co., Ltd.20220—
+5K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+5K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+5K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—
+5K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+5K210356Noris Medical Dental Implants SystemNoris Medical, Ltd.20221—
+5K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+5K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+5K212538DESS Dental ImplantsTerrats Medical SL20211—
+5K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+5K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+5K210886MIS Lance+ Conical Connection Dental Implant SystemDentsply Sirona20210—
+5K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+5K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+5K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+5K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+5K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+5K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+5K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+5K183044JTK Dental Implant SystemJiangyin Jintech Biotech Co., Ltd.20200—
+5K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+5K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+5K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH20209—
+5K200102MIS Dental Implant SystemDentsply Sirona20200—
+5K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+5K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+5K191443MSDI Dental Implants SystemMedical Systems and Devices International, Ltd.20201—
+5K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+5K193335SherlockOpen Implants, LLC20203—
+5K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+5K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+5K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+5K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+5K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+5K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+5K190958Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20195—
+5K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+5K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+5K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+5K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+5K183242ET IV SA Dental ImplantsHiossen, Inc.20190—
+5K182228MIS LOCKiT Abutments System, OT-Equators and Ball AttachmentsMis Implants Technologies, Ltd.20190—
+5K173701Implant-One SystemImplant Logistics, Inc.20181—
+5K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+5K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+5K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+5K173961Straumann BLX Implant SystemInstitut Straumann AG201815—
+5K180609Rodo SmilekeyRodo Medical, Inc.20180—
+5K172240SPI Dental Implant SystemMsi France20180—
+5K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+5K170394Kisses MiniAchimhai Medical Corporation20170—
+5K171728MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mmSterngold Dental, LLC20172—
+5K162482A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20174—
+5K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+5K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH20171—
+5K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+5K161103US SA Implant SystemOsstem Implant Co., Ltd.20170—
+5K161497Dental Implants and AbutmentsDitron Precision, Ltd.20161—