510(k) Report

Devices descending from K894593

536 later devices reach Bonefit Hollow Cylinder Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K052733Almitech Inc. Dental Implant SystemAlmitech, Inc.20050—
+1K052490Endosseous Dental Implant SystemNorthern Implants, LLC200531—
+1K033171Nsi Hexed and Non-Hexed Implant System and Immediate LoadingNorthern Implants, LLC200432—
+1K983742Iti Dental Implant SystemInstitut Straumann AG1999510—
+2K163060Deep Conical (DC) Implants and AccessoriesSouthern Implants (Pty), Ltd.20177—
+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—
+2K082651Endosseous Dental Implant SystemSouthern Implants, Inc.200814—
+2K071161Endosseous Dental Implant SystemSouthern Implants, Inc.200762
+2K070841Endosseous Dental Implant SystemSouthern Implants, Inc.200721—
+2K070905Endosseous Dental Implant SystemSouthern Implants, Inc.2007171
+2K061169Endosseous Dental ImplantNorthern Implants, LLC200624—
+2K033984Straumann Dental Implant SystemInstitut Straumann AG2004376—
+2K033922Modification to Iti Dental Implant SystemInstitut Straumann AG20043461
+2K991822Allfit Implant System, Short Neck, Model Sti RT Length, Allfit Implant System, Long…Dr. Ihde Dental AG Switzerland20010—
+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—
+3K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+3K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20202—
+3K191054Southern Implants MAX Implant SystemSouthern Implants (Pty), Ltd.20191—
+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—
+3K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+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—
+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—
+3K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc.2014109—
+3K122664Zuga Dental Implant SystemZuga Medical, Inc.20131—
+3K130222Straumann Dental Implant SystemStraumann USA, LLC2013118—
+3K1221986.00MM X 6.00MM Macro External Implant SystemOco Biomedical20130—
+3K112787KeratorKj Meditech Co., Ltd.20123—
+3K110337Universal Maxillary MolarOco Biomedical20121—
+3K101945Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2011180—
+3K093749GC Aadva Implant SystemGC America, Inc.20100—
+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—
+3K083633HS II Short Fixture SystemOsstem Implant Co., Ltd.200976—
+3K073622Easy Grip Dental Implant SystemT.F.I. System S.R.L20080—
+3K072425Jne Implant SystemGC America, Inc.20081—
+3K072917JJG Evolution Orthodontic Implant SystemOdontit S.A.20080—
+3K063364Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd.2007187—
+3K061176Straumann Dental ImplantsInstitut Straumann AG2006148—
+3K053088Slactive ImplantsInstitut Straumann AG2006295—
+3K040757Sic ProSic Invent AG20052—
+4K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+4K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+4K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+4K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+4K241183ISO AbutmentSeum Medi Co., Ltd.20250—
+4K251280DESS® Dental ImplantsTerrats Medical SL20250—
+4K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+4K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K231566ICX-Implant SystemMedentis Medical GmbH20240—
+4K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+4K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+4K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+4K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+4K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+4K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+4K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+4K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+4K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+4K212364BLT Dental Implant SystemBio Concept Co., Ltd.20220—
+4K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+4K212533BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) ImplantsInstitut Straumann AG20221—
+4K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+4K202092ABC Dental Implant SystemAbracadabra Implants, Ltd.20210—
+4K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+4K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+4K192839DSP Implant SystemD.S.P Industrial Eireli20210—
+4K202942Straumann 4 mm Short ImplantsStraumann USA, LLC20210—
+4K201491Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20205—
+4K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20207—
+4K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+4K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+4K193234NUVO IF Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20206—
+4K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+4K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+4K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+4K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+4K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+4K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+4K182246Mist ICImagine Milling Technologies, LLC20194—
+4K183518Preat AbutmentsPreat Corporation2019223