510(k) Report

Devices descending from K894595

1,051 later devices reach Bonefit R Screw Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K061169Endosseous Dental ImplantNorthern Implants, LLC200624—
+1K052733Almitech Inc. Dental Implant SystemAlmitech, Inc.20050—
+1K994205Modification of Regular Diameter Single Stage (RDS) TPS Dental Implant SystemLifecore Biomedical, Inc.20001—
+1K991114Regular Diameter Single Stage (RDS) TPS Dental Implant SystemLifecore Biomedical, Inc.19992—
+1K984104Iti Dental Implant SystemStraumann USA19991,0431
+1K983742Iti Dental Implant SystemInstitut Straumann AG1999510—
+1K955281Endosseous Dental Implant & AccessoriesThe Straumann Co.199627—
+2K150938Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsStraumann USA, LLC201562
+2K140878Straumann Bone Level Tapered ImplantStraumann USA, LLC20141052
+2K123784Straumann Dental Implant SystemStraumann USA, LLC2013122—
+2K122855TL 04.1MM RN,S, Slactive Tizr 6, 8, 10, 12, 14, 16MM Dental ImplantsStraumann USA2012123—
+2K073622Easy Grip Dental Implant SystemT.F.I. System S.R.L20080—
+2K070841Endosseous Dental Implant SystemSouthern Implants, Inc.200721—
+2K070905Endosseous Dental Implant SystemSouthern Implants, Inc.2007171
+2K053643Stage- 1 Temporary/Healing Cap, Model 42021-42026Lifecore Biomedical, Inc.20060—
+2K033984Straumann Dental Implant SystemInstitut Straumann AG2004376—
+2K034067Zti Implants System, DRM ImplantsDrm Research Laboratories, Inc.20040—
+2K033922Modification to Iti Dental Implant SystemInstitut Straumann AG20043461
+2K0306143I Dental ImplantsImplant Innovations, Inc.2003319—
+2K012681AnkylosDentsply Ceramco20037—
+2K030007Iti Dental Implant SystemStraumann USA2003570—
+2K021322Endossous ImplantsIntra-Lock International20026—
+2K0134943.75MM and 5.0MM Spline Twist ImplantSulzer Dental, Inc.20020—
+2K013227Screw Vent Implant; Tapered Screw Vent ImplantSulzer Dental, Inc.20013052
+2K991822Allfit Implant System, Short Neck, Model Sti RT Length, Allfit Implant System, Long…Dr. Ihde Dental AG Switzerland20010—
+2K992937Dental ImplantNobel Biocare Uas, Inc.20007351
+2K993595Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon Placement)Nobel Biocare Uas, Inc.2000942—
+3K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+3K230108Straumann® BLC and TLC ImplantsInstitut Straumann AG20234—
+3K212538DESS Dental ImplantsTerrats Medical SL20211—
+3K182313BoneTrust Implant SystemMedical Instinct Deutschland GmbH20190—
+3K180465Provata Implant SystemSouthern Implants (Pty), Ltd.20182—
+3K171197Zuga Dental Implant SystemZuga Medical, Inc.20180—
+3K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+3K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+3K163634External Hex ImplantsSouthern Implants (Pty), Ltd.2017131
+3K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+3K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+3K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+3K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH20171—
+3K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+3K153758Straumann Bone Level Tapered ImplantsInstitut Straumann AG20160—
+3K150388Dental Implant SystemBio Concept Co., Ltd.20151—
+3K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+3K142751Chang Gung ComMed Series Dental Implant SystemChang Gung Medical Technology Co., Ltd.20150—
+3K133733WINSIX Implant SystemBiosaf IN S.R.L.20150—
+3K142082Zimmer 3.1MM Dental Implant;2.9MM Angled Abutment;Straight Hex, 2.9MM Contour AbutementZimmer Dental, Inc.20140—
+3K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc.2014109—
+3K133255Zeramex T and Zeramex Plus Dental Implant SystemsDentalpoint AG20143—
+3K133339Zimmer Dental Tapered Screw Vent T Implant, HA Coated;Zimmer Dental Tapered Screw-Vent M…Zimmer Dental, Inc.20143—
+3K130572Interactive/ SWISHPLUS2 Implant SystemImplant Direct Sybron Manufacturing, LLC2013104
+3K132258Zimmer Dental Trabecular Metal Implant SystemZimmer Dental, Inc.20130—
+3K131097LEGACY3 6MM Length ImplantsImplant Direct Sybron Manufacturing, LLC20130—
+3K122664Zuga Dental Implant SystemZuga Medical, Inc.20131—
+3K130222Straumann Dental Implant SystemStraumann USA, LLC2013118—
+3K113753Zimmer Dental Tapered Screw-Vent XZimmer Dental, Inc.20121—
+3K112787KeratorKj Meditech Co., Ltd.20123—
+3K112160Tapered Screw-Vent X ImplantZimmer Dental, Inc.20118819
+3K103194Intra-Lock Dental Implants with BlossomIntra-Lock International, Inc.20115—
+3K101945Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2011180—
+3K093749GC Aadva Implant SystemGC America, Inc.20100—
+3K101880Tapered Screw-Vent T Implant, Tapered Screw-Vent P ImplantZimmer Dental, Inc.2010941
+3K100985Biohorizons Simple Solutions with Laser-LokBioHorizons Implant Systems, Inc.201073—
+3K101207Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2010181—
+3K092261Defcon Tsa/TSH Dental Implant SystemImpladent, S.L.20100—
+3K082573Sargon Non-Expandable Dental ImplantSargon Ent., Inc.20100—
+3K093615Spi Dental Implant, ElementThommen Medical AG20101—
+3K091878Osseolink Dental Implant SystemGlobal Implant Solutions, LLC20090—
+3K090709Cortex Dental Implant SystemCortex Dental Implants Industries, Ltd.20090—
+3K083633HS II Short Fixture SystemOsstem Implant Co., Ltd.200976—
+3K081226Simpact Implant SystemSimpact, LLC20081—
+3K072730Friadent Cercon and Ankylos Cercon Balance AbutmentsDentsply Intl.20080—
+3K072425Jne Implant SystemGC America, Inc.20081—
+3K073161Replus Dental Implants (HA)Implant Direct, LLC200843—
+3K072917JJG Evolution Orthodontic Implant SystemOdontit S.A.20080—
+3K072589Tapered Screw-Vent Implant, 4.1MM, Models: TSV4B8, B10, B11, B13 and B16, TSV4H8, H11…Zimmer Dental, Inc.2007983
+3K063106Revois Implant SystemCurasan AG20072—
+3K062636Osseotite, Osseotite NY, Certain, Certain NT, Prevail, Certain Prevail, XP…Implant Innovations, Inc.200728—
+3K063364Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd.2007187—
+3K061410Screw-Vent Implant System, SV;Tapered Screw -Vent Implant System, TSV;Advent Implant…Zimmer Dental, Inc.20061221
+3K060958Straumann Narrow Neck ImplantsStraumann USA2006228—
+3K061176Straumann Dental ImplantsInstitut Straumann AG2006148—
+3K052254Mytis Arrow XXXXBrainbase Corporation20060—
+3K053088Slactive ImplantsInstitut Straumann AG2006295—
+3K050956TBR Idea Conic/ConicSudimplant SA20062—
+3K052369Exfeel Implant SystemMegagen Co., Ltd.200684—
+3K0514613I Osseotite Dental ImplantsImplant Innovations, Inc.2005312—
+3K040757Sic ProSic Invent AG20052—
+3K042971Titan Dental Implant SystemTitan Implants, Inc.20050—
+3K041655Bio Plant System (Implants and Abutments)Cowellmedi Co., Ltd.200491—
+3K040946Ankylos Dental Implant SystemFriadent GmbH20043—
+3K041402Modification to Osseotite NT Certain ImplantsImplant Innovations, Inc.2004318—
+3K040807Mis Dental Implant SystemMis - Implant Technologies, Ltd.2004218—
+3K033171Nsi Hexed and Non-Hexed Implant System and Immediate LoadingNorthern Implants, LLC200432—
+3K034014Spi Contact Dental ImplantThommen Medical AG20043—
+3K032774Renova Internal Hex Implant SystemLifecore Biomedical, Inc.200349—
+3K023113Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc.200268927
+3K0118793A Dental Implant SystemOsseco Biosource, Ltd.2002223—
+3K013067Frialoc Dental Implant SystemFriadent GmbH2002568—
+4K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—