510(k) Report

Devices descending from K954512

702 later devices reach Restore Self Tapping Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K043042Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB2004327—
+1K042658Procera Abutment Branemark, Models 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004Nobel Biocare Uas, Inc.2004441—
+1K983742Iti Dental Implant SystemInstitut Straumann AG1999510—
+1K965135Lifecore Conical AbutmentLifecore Biomedical, Inc.19970—
+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—
+2K103252Camlog Vario SR AbutmentsAltatec GmbH201132—
+2K091848Nobel/Procera Implant BridgeNobel Biocare AB20091—
+2K091904Nobelprocera ZI AbutmentNobel Biocare AB200935—
+2K091756Nobelprocera TI AbutmentNobel Biocare AB2009278—
+2K090069Procera Implant Bridge OverdentureNobel Biocare AB2009313—
+2K083192Inclusive Titanium Abutment BlanksInclusive Dental Solutions200940—
+2K073217Inclusive Implant AbutmentsInclusive Dental Solutions20083—
+2K061529Procera Zirconia Abutment for Camlog Implant SystemNobel Biocare AB200626—
+2K061478Procera Titanium Abutment for Astratech and Camlog Implant SystemsNobel Biocare AB200633—
+2K052823Implantium AbutmentsDentium, Inc.200621—
+2K053091Procera Implant Bridge ZirconiaNobel Biocare AB20066—
+2K051501ZiraceAcucera, Inc.20058—
+2K052070Atlantis Abutment in Zirconia, Atlantis Gemini Abutment in Zirconia, Atlantis Gemeini +…Atlantis Components, Inc.2005261—
+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—
+3K233208NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw TitaniumNobel Biocare AB20242—
+3K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+3K230108Straumann® BLC and TLC ImplantsInstitut Straumann AG20234—
+3K212538DESS Dental ImplantsTerrats Medical SL20211—
+3K182313BoneTrust Implant SystemMedical Instinct Deutschland GmbH20190—
+3K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+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—
+3K151439Atlantis IsusDentsply International, Inc.20160—
+3K150388Dental Implant SystemBio Concept Co., Ltd.20151—
+3K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+3K143051ArgenIS Titanium AbutmentsThe Argen Corporation20152—
+3K142751Chang Gung ComMed Series Dental Implant SystemChang Gung Medical Technology Co., Ltd.20150—
+3K133733WINSIX Implant SystemBiosaf IN S.R.L.20150—
+3K141923Inclusive Titanium Abutments, Compatible with Dentsply Implants Ankylos C/XPrismatik Dentalcraft, Inc.20150—
+3K142118Inclusive Titanium Abutments Compatible with: Straumann Bone Level, Nobel Biocare BranaePrismatik Dentalcraft, Inc.20142—
+3K142115Inclusive Titanium Abutments Compatible with: Zimmer, Biomet 3I, and Nobel Biocare ImplantPrismatik Dentalcraft, Inc.201421
+3K141457Dentium Implantium and Superline AbutmentsDentium Co., Ltd.20146—
+3K141211Inclusive Titanium Abutments Compatible with Straumann Tissue Level ImplantsPrismatik Dentalcraft, Inc.20141—
+3K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc.2014109—
+3K132749Nobelprocera Overdenture BarNobel Biocare USA, LLC20140—
+3K132881Z5CZ-Systems AG20148—
+3K132956U Fit Dental Implant SystemT Strong, Inc.20141—
+3K133731Nobelactive Wide Platform (WP)Nobel Biocare AB2014101—
+3K134045Zimmer ZFX Titanium Abutment, Base Abutment and Abutment Blank for Nobelactive Implant…Zimmer Dental, Inc.201414—
+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—
+3K113738Creodent Solidex Custom AbutmentCreodent Prosthetics, Ltd.20137—
+3K122424Isus Implant SuprastructuresDentsply International, Inc.201313—
+3K130222Straumann Dental Implant SystemStraumann USA, LLC2013118—
+3K120089Biogenesis Implant SystemBiogenesis Co., Ltd.20130—
+3K122602Nobelprocera TI Abutment Camlog PlatformsNobel Biocare AB20130—
+3K113779Conelog Implant SystemAltatec GmbH201214—
+3K120858Implant BarPrismatik Dentalcraft, Inc.20120—
+3K120873Zimmer ZFX Abutment for Nobel Replace Implant SystemZimmer Dental, Inc.201216—
+3K121334VarioecoThommen Medical AG201216—
+3K112787KeratorKj Meditech Co., Ltd.20123—
+3K111421Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH201254—
+3K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc.201130—
+3K101945Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S2011180—
+3K101465Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG2010167—
+3K093749GC Aadva Implant SystemGC America, Inc.20100—
+3K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH2010240—
+3K101714Nobelprocera TI Abutment Thommen PlatformsNobel Biocare AB20101—
+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—
+3K093780Atlantis Abutment for Dentsply Implant, Atlantis Gemini Abutment, Atlantis Gemini +…Astra Tech, Inc.2010200—
+3K093615Spi Dental Implant, ElementThommen Medical AG20101—
+3K091907Nobelprocera Implant Bridge ZirconiaNobel Biocare AB20095—
+3K091920Atlantis Abutment in Zirconia, Atlantis Gemini Abutment for Nobel Replace Implants…Astra Tech, Inc.200940—
+3K090976Vericore Abutment in Zirconia for Implant SystemsWhip-Mix Corp.20091—
+3K083633HS II Short Fixture SystemOsstem Implant Co., Ltd.200976—
+3K083871Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann Bone Level Abutment…Astra Tech, Inc.20094—
+3K081748Oneplant Dental Implant SystemWarantec Co., Ltd.20099—
+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—
+3K063494Doro Radiolucent Headrest System ( Also Mri-Compatible) and ComponentsPro-Med Instruments GmbH20077—
+3K063364Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd.2007187—
+3K063734Atlantis Abutment in Zirconia for 3I Certain InterfaceAtlantis Components, Inc.200738—
+3K062277Atlantis Abutment in Zirconia for Nobel Biocare ReplaceAtlantis Components, Inc.200671—
+3K061176Straumann Dental ImplantsInstitut Straumann AG2006148—
+3K053450Atlantis Abutment for Zimmer InterfaceAtlantis Components, Inc.20062—
+3K053088Slactive ImplantsInstitut Straumann AG2006295—
+3K040757Sic ProSic Invent AG20052—
+4K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+4K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+4K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC…Nobel Biocare AB20260—
+4K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+4K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—