510(k) Report

Devices descending from K894844

764 later devices reach Bonefit Implant System Accessories & Instruments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K130808Straumann Healing Abutments, Healing Caps, Closure ScrewsStraumann USA201339—
+1K113410NNC Solid Abutment NNC Temporary Coping for Colid Abutment NNC Temporary Cap for Colid…Straumann USA20121—
+1K082532Straumann Guided InstrumentsStraumann USA20083—
+1K080239P.004 Abutments, P.004 Temporary Copings, P.004 Protective Caps, P.004 Permanent CopingsStraumann Manufacturing, Inc.2008164—
+1K071919P.004 AbutmentsStraumann USA (On Behalf of Institut Straumann Ag)20070—
+1K013798Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG2001575—
+1K990342Synocta ProstheticsStraumann USA1999696—
+1K973353Bonding BaseStraumann USA199767—
+2K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+2K241575Straumann® Anatomic Healing Abutments XC (AHA)Straumann USA, LLC202401
+2K200265Surgical DrillsImplant Direct Sybron Manufacturing, LLC20201—
+2K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.2017306
+2K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+2K161677Straumann Sterile Healing SolutionInstitut Straumann AG20160—
+2K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+2K142167Medentika Abutment SystemMedentika GmbH20157—
+2K133421Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal ScrewStraumann USA, LLC2014115—
+2K130618Sfi-AnchorCendres & Metaux SA20142—
+2K111935TI-Base Abutment, 1 Connect AbutmentNt-Trading GmbH and CO KG201264—
+2K090081Talladium International Implantology AbutmentsTalladium Espana, SL20100—
+2K090260Modification to:Straumann Guided InstrumentsStraumann Manufacturing, Inc.20090—
+2K062436Sis Sinus Implant StabilizerMondeal Medical Systems GmbH20070—
+2K061277Straumann Computer Aided Restoration Service (C.a.R.E.S.) Ceramic CopingStraumann USA2007265—
+2K063364Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd.2007187—
+2K061169Endosseous Dental ImplantNorthern Implants, LLC200624—
+2K051717RN Synocta Temporary Meso AbutmentInstitut Straumann SA2005318—
+2K022859Abutment and Prosthetic Accessories to the Iti Dental Implant SystemStraumann USA2002520—
+2K020096Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG20025161
+2K012757Iti Dental Implant SystemStraumann USA2001535—
+2K994119Synocta Angled AbutmentsStraumann USA2000175—
+2K982509Ortho Implant and AccessoriesStraumann USA199866—
+3K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+3K242686Neodent Implant SystemJjgc Indústria E Comércia DE Materiais Dentários S.A.202421
+3K231566ICX-Implant SystemMedentis Medical GmbH20240—
+3K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+3K231803Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20231—
+3K232418Single Platform SP1 Implant SystemSouthern Implants (Pty), Ltd.20232—
+3K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+3K230104Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BLAnthogyr20230—
+3K231087Guided Surgery KitImplant Direct Sybron Manufacturing, LLC20230—
+3K223638Neodent Implant System - Helix Short Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+3K202092ABC Dental Implant SystemAbracadabra Implants, Ltd.20210—
+3K203382Neodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A.202102
+3K202282Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+3K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+3K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—
+3K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+3K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+3K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+3K191191Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+3K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+3K172668W Zirconia ImplantsTav Medical, Ltd.20184—
+3K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+3K180536Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20182—
+3K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+3K171757Straumann Screw Retained AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)201714—
+3K162299Spiral Shape Dental Implant SystemGp Implants20173—
+3K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+3K152509CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)Altatec GmbH20160—
+3K151916TRI Dental Implant SystemTri Dental Implants Int. AG20154—
+3K150899Straumann CARES Titanium Alloy (TAN) AbutmentStraumann USA, LLC201511—
+3K151247NC Straumann Screw Retained AbutmentsStraumann USA, LLC20150—
+3K150814Straumann Screw-Retained AbutmentStraumann USA, LLC20150—
+3K150938Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsStraumann USA, LLC201562
+3K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+3K150363NOVA Dental Implants SystemNova Implants, Ltd.20150—
+3K142407Straight Stud AttachmentSterngold Dental, LLC20141—
+3K133362SGS Dental ImplantSgs International, Ltd.20142—
+3K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+3K140737Straumann Cares Screw Retained Bars/BridgeStraumann USA, LLC20140—
+3K141871Straumann Bone Level NC Angled Screw Retained AbutmentsStraumann USA, LLC20142—
+3K132219Straumann (R) Variobase (TM) Abutment NNC, Straumann (R) Variobase (TM) Abutment RN…Straumann USA, LLC201435—
+3K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425—
+3K122295Core 3D Abutment System for Digital Prosthetic SolutionsCore 3D Protech, S.L.201329—
+3K123784Straumann Dental Implant SystemStraumann USA, LLC2013122—
+3K122855TL 04.1MM RN,S, Slactive Tizr 6, 8, 10, 12, 14, 16MM Dental ImplantsStraumann USA2012123—
+3K122192NC Temporary Abutment, Cad-Temp, Pmma RC Temporary Abutment, Cad-Temp, Pmma RN Temporary…Straumann USA, LLC20121—
+3K120530Dentin Dental Implants System: Rapid, Classic, Prestige, One Piece, Dentin Dental…Dentin Implants Technologies, Ltd.20120—
+3K111798Sternic Implant 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN, 1.8MM…Sterngold Dental, LLC20121—
+3K112795Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.2012115
+3K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+3K103280Bhdental Implant SystemBhdental, Ltd.20110—
+3K101945Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2011180—
+3K082800Star/Vent Internal Hex Screw ImplantPark Dental Research Corp.20100—
+3K101207Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2010181—
+3K082573Sargon Non-Expandable Dental ImplantSargon Ent., Inc.20100—
+3K093113Etkon ES1, Model 019.0001, Etkon Visual, Straumann Cadcam AbutmentInstitut Straumann AG2009169—
+3K082545Straumann NN Cares Titanium and Ceramic AbutmentsInstitut Straumann AG2008171—
+3K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp.20081411
+3K071803Ards Dental ImplantsArds, Ltd.200813—
+3K073622Easy Grip Dental Implant SystemT.F.I. System S.R.L20080—
+3K073628Synocta AbutmentsStraumann USA2008211—
+3K070478P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap)Straumann Manufacturing, Inc.2007283—
+3K072151P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA20072641
+3K070744Narrow Neck Temporary CopingInstitut Straumann AG20070—
+3K070841Endosseous Dental Implant SystemSouthern Implants, Inc.200721—
+3K070533Bti Endosseous Dental Implant Angled AbutmentsB.T.I. Biotechnology Institute, Sl.20070—
+3K070905Endosseous Dental Implant SystemSouthern Implants, Inc.2007171
+3K062733Tomas Pin SD 6, 8, and 10 MMDentaurum20066—
+3K062129P.0004 ImplantsInstitut Straumann AG2006434—