510(k) Report

Devices descending from K032284

394 later devices reach Xive TG Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063106Revois Implant SystemCurasan AG20072—
+1K040170Friadent Plus Dental Implant SystemsFriadent GmbH200484—
+1K033984Straumann Dental Implant SystemInstitut Straumann AG2004376—
+2K142751Chang Gung ComMed Series Dental Implant SystemChang Gung Medical Technology Co., Ltd.20150—
+2K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc.2014109—
+2K113539Revois Pro Implant StsyemRiemser Arzneimittel AG20130—
+2K130222Straumann Dental Implant SystemStraumann USA, LLC2013118—
+2K123784Straumann Dental Implant SystemStraumann USA, LLC2013122—
+2K113042Revois Implant SystemRiemser Arzneimittel AG20130—
+2K122855TL 04.1MM RN,S, Slactive Tizr 6, 8, 10, 12, 14, 16MM Dental ImplantsStraumann USA2012123—
+2K112787KeratorKj Meditech Co., Ltd.20123—
+2K102804Spi Titanium Base for Cad/CamThommen Medical AG201183—
+2K093749GC Aadva Implant SystemGC America, Inc.20100—
+2K092261Defcon Tsa/TSH Dental Implant SystemImpladent, S.L.20100—
+2K082573Sargon Non-Expandable Dental ImplantSargon Ent., Inc.20100—
+2K093615Spi Dental Implant, ElementThommen Medical AG20101—
+2K072425Jne Implant SystemGC America, Inc.20081—
+2K072917JJG Evolution Orthodontic Implant SystemOdontit S.A.20080—
+2K063364Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd.2007187—
+2K053088Slactive ImplantsInstitut Straumann AG2006295—
+2K040757Sic ProSic Invent AG20052—
+3K241183ISO AbutmentSeum Medi Co., Ltd.20250—
+3K231566ICX-Implant SystemMedentis Medical GmbH20240—
+3K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+3K212533BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) ImplantsInstitut Straumann AG20221—
+3K202092ABC Dental Implant SystemAbracadabra Implants, Ltd.20210—
+3K202942Straumann 4 mm Short ImplantsStraumann USA, LLC20210—
+3K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+3K173141CSM Submerged3-L Implant SystemCsm Implant20180—
+3K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+3K171784Straumann Dental Implant SystemStraumann USA, LLC20184—
+3K171795Thommen Implant SystemThommen Medical AG20170—
+3K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+3K162299Spiral Shape Dental Implant SystemGp Implants20173—
+3K151626ET III Bio-SA Fixture SystemHiossen, Inc.201691
+3K150388Dental Implant SystemBio Concept Co., Ltd.20151—
+3K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+3K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S201589—
+3K150363NOVA Dental Implants SystemNova Implants, Ltd.20150—
+3K150199Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20151—
+3K150182Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S201518—
+3K142167Medentika Abutment SystemMedentika GmbH20157—
+3K133362SGS Dental ImplantSgs International, Ltd.20142—
+3K140728Mpi - Molecular Precision Implant, Cpi - Cylindrical Precision Implant, Opi - One Piece…Ditron Precision, Ltd.20146—
+3K140878Straumann Bone Level Tapered ImplantStraumann USA, LLC20141052
+3K132144KeratorLK Consulting Group USA, Inc.20140—
+3K132125A.B. Dental Devices Dental Implants SystemA.B. Dental Devices, Ltd.201425—
+3K122988Klockner Dental Implant AbutmentsSoadco, S.L.20139—
+3K120530Dentin Dental Implants System: Rapid, Classic, Prestige, One Piece, Dentin Dental…Dentin Implants Technologies, Ltd.20120—
+3K112795Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.2012115
+3K112440AB Dental Devices Implants and AccessoriesA.B. Dental Devices, Ltd.201236—
+3K103291Biohorizons Laser-Lok Abutments for Nobel BiocareBioHorizons Implant Systems, Inc.201130—
+3K103691Biohorizons Abutments for ZimmerBioHorizons Implant Systems, Inc.2011451
+3K103280Bhdental Implant SystemBhdental, Ltd.20110—
+3K101545Genesis Implant SystemKeystone Dental2010153
+3K082800Star/Vent Internal Hex Screw ImplantPark Dental Research Corp.20100—
+3K093643Multi- Unit Abutments for Straumann and Astra Tech Implant SystemsNobel Biocare AB201034—
+3K083871Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann Bone Level Abutment…Astra Tech, Inc.20094—
+3K083550Straumann Dental Implant SystemStraumann USA2009228—
+3K081419Straumann Dental Implant SystemInstitut Straumann AG2009142—
+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—
+3K060958Straumann Narrow Neck ImplantsStraumann USA2006228—
+3K061500Sicace Dental Implant System and Sic Angled AbutmentsSic Invent AG20061—
+4K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+4K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+4K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+4K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+4K243066Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+4K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+4K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+4K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+4K223083Straumann SLActive labeling changesInstitut Straumann AG20230—
+4K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+4K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+4K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+4K212364BLT Dental Implant SystemBio Concept Co., Ltd.20220—
+4K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+4K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+4K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+4K212538DESS Dental ImplantsTerrats Medical SL20211—
+4K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+4K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+4K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+4K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+4K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+4K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+4K191443MSDI Dental Implants SystemMedical Systems and Devices International, Ltd.20201—
+4K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+4K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+4K182219SGS Dental Implants SystemSgs International, Ltd.20191—
+4K182455A.B. DENTAL DEVICES Dental Implants SystemA.B. Dental Device, Ltd.20190—
+4K180968AlphaDent Implants Dental Implants SystemAlphadent Implants, Ltd.20190—
+4K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+4K182246Mist ICImagine Milling Technologies, LLC20194—
+4K183518Preat AbutmentsPreat Corporation2019223