510(k) Report

Devices descending from K894844

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+4K122664Zuga Dental Implant SystemZuga Medical, Inc.20131—
+4K130222Straumann Dental Implant SystemStraumann USA, LLC2013118—
+4K121281Simpli Simpler Implant SystemSimpler Implant Solutions20130—
+4K120861Fin-S MicroimplantCreekside Orthodontics20130—
+4K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG2012165—
+4K122052Minifix Ball Minifix OneBonafix Surgical and Dental Implants, LLC20120—
+4K113650Orthofix ScrewBonafix Surgical and Dental Implants, LLC20121—
+4K121707Lew Mdi O-Ball Collared Implant,Park Dental Research Corp.20121—
+4K112787KeratorKj Meditech Co., Ltd.20123—
+4K121131BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MMStraumann USA20121241
+4K111421Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH201254—
+4K113283NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC…Straumann USA2011166—
+4K111390Sfi-Bar (R) Implant Adapter Spi (R) Element PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0…Cendres & Metaux SA2011201—
+4K110778Biodenta Customized AbutmentBiodenta Swiss AG20112—
+4K110275Ortho Easy PinForestadent Bernhard Forster GmbH20111—
+4K102034Blue Sky Bio Dental Implant SystemBlue Sky Bio, LLC20114—
+4K103339TDS Abutment for Friadent XivePou YU Biotechnology Co., Ltd.20113—
+4K093299Synthes Orthodontic Bone Anchor SystemSynthes (Usa)20103—
+4K101465Straumann Cares Bridge; Straumann Cares Dolder BarInstitut Straumann AG2010167—
+4K093749GC Aadva Implant SystemGC America, Inc.20100—
+4K092261Defcon Tsa/TSH Dental Implant SystemImpladent, S.L.20100—
+4K093643Multi- Unit Abutments for Straumann and Astra Tech Implant SystemsNobel Biocare AB201034—
+4K093615Spi Dental Implant, ElementThommen Medical AG20101—
+4K093027Straumann RC Temporary AbutmentsStraumann USA201097—
+4K091701Straumann Modified Dental AbutmentInstitut Straumann AG200911—
+4K083871Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann Bone Level Abutment…Astra Tech, Inc.20094—
+4K083192Inclusive Titanium Abutment BlanksInclusive Dental Solutions200940—
+4K083550Straumann Dental Implant SystemStraumann USA2009228—
+4K082838Orlus Mini ScrewOrtholution Co., Ltd.20081—
+4K081393Orthodontic Temporary Anchorage Implant ScrewG & H Wire Co.20080—
+4K081078NT/IT SystemOsstem Implant Co., Ltd.20080—
+4K081005P.004 NC Cares Titanium and Ceramic AbutmentsInstitut Straumann AG20082631
+4K072425Jne Implant SystemGC America, Inc.20081—
+4K073461Ortho Anchor ScrewsMis Implants Technologies, Ltd.20080—
+4K072917JJG Evolution Orthodontic Implant SystemOdontit S.A.20080—
+4K071851HDC Sterile Spider ScrewHdc S.R.L.20072—
+4K071888Straumann P.004 RC Gold Abutment for BridgesStraumann USA20071—
+4K072679P.004 AbutmentsInstitut Straumann AG2007279—
+4K072497P.004 NC Gold Abutment for CrownsInstitut Straumann AG2007224—
+4K071357P.004 NC Anatomic AbutmentsInstitut Straumann AG2007114—
+4K070549Straumann P.004 RC Gold AbutmentInstitut Straumann AG2007225—
+4K072071Straumann P.004 Cementable Abutments, Temporary Copings and Protective CapsInstitut Straumann AG2007205—
+4K071585P.004 Healing Abutments and Closure ScrewsStraumann USA20072331
+4K063789WN Synocta Gold AbutmentStraumann USA20070—
+4K063770Alpha-Bio Orthodontic Fixation Screw SystemAlpha-Bio Tec, Ltd.20071—
+4K063149Orthodontic Taads (Temporary Anatomical Anchor Device System)T.O.a.D.S., LLC20072—
+4K062367Miniscrews Anchoring System, M.a.S.Micerium S.P.A.20061—
+4K062156Super Orthodontic ScrewOsstem Implant Co., Ltd.20066—
+4K061397Ace Surgical Orthodontic Bone Screw Systems, 1.2/1.5 MM X 6MM,8MM, Model…Ace Surgical Supply Co., Inc.20066—
+4K061500Sicace Dental Implant System and Sic Angled AbutmentsSic Invent AG20061—
+4K060500Speedy Orthodontic ScrewDentium Co., Ltd.20060—
+4K053629Anchor Plus/Neo Anchor PlusKj Meditech20060—
+4K060126Absoanchor MicroimplantDentos, Inc.200619—
+4K053088Slactive ImplantsInstitut Straumann AG2006295—
+4K052272Straumann Computer Aided Restoration ServiceStraumann USA2006268—
+4K052471HDC Spider ScrewHdc S.R.L.20054—
+4K051552O.a.S.I. SystemLancer Orthodontics, Inc.20050—
+4K050568Orlus Mini ScrewOrtholution Co., Ltd.20055—
+4K050669Jeil Bone Fixation SystemJeil Medical Corporation20058—
+4K040170Friadent Plus Dental Implant SystemsFriadent GmbH200484—
+4K041275Procera Abutment OctagonNobel Biocare Uas, Inc.200461—
+4K041236Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052Nobel Biocare AB2004328—
+5K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+5K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+5K260268OrthoEasy Pal; OrthoEasy Pal Long NeckBernhard Förster GmbH (Bernhard Foerster Ltd.)20260—
+5K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+5K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+5K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+5K250271Neodent Implant System - Zirconia Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+5K241183ISO AbutmentSeum Medi Co., Ltd.20250—
+5K243478Straumann InLab Validated WorkflowInstitut Straumann AG20250—
+5K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+5K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+5K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+5K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+5K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+5K240202Conical Platform Dental Implants SystemNoris Medical, Ltd.20240—
+5K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+5K232821S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+5K233389EK Digital AbutmentsHiossen, Inc.20240—
+5K232726External Hex Implant SystemSouthern Implants (Pty), Ltd.20240—
+5K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+5K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+5K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+5K222026Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+5K221488Z7 Zirconia Implant SystemZ7, LLC20230—
+5K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+5K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+5K222457Provata Implant SystemSouthern Implants (Pty), Ltd.20230—
+5K222984BioClean Implant Restorative SystemBioclean Dental, LLC20220—
+5K213677Bonafix 2 PlusZentek Medical, LLC20220—
+5K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+5K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+5K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+5K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+5K220251Neodent Implant System - GM Narrow Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20221—
+5K212364BLT Dental Implant SystemBio Concept Co., Ltd.20220—
+5K211952BTI Interna Narrow/Plus Dental Implant System UnicCaB.T.I. Biotechnology Institute, Sl.20221—
+5K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+5K210852Noris Medical Dental Implants System - CorticalNoris Medical, Ltd.20220—