510(k) Report

Devices descending from K012757

535 later devices reach Iti Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K151916TRI Dental Implant SystemTri Dental Implants Int. AG20154—
+1K150938Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsStraumann USA, LLC201562
+1K123784Straumann Dental Implant SystemStraumann USA, LLC2013122—
+1K122855TL 04.1MM RN,S, Slactive Tizr 6, 8, 10, 12, 14, 16MM Dental ImplantsStraumann USA2012123—
+1K111798Sternic Implant 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN, 1.8MM…Sterngold Dental, LLC20121—
+1K082573Sargon Non-Expandable Dental ImplantSargon Ent., Inc.20100—
+1K073622Easy Grip Dental Implant SystemT.F.I. System S.R.L20080—
+1K062129P.0004 ImplantsInstitut Straumann AG2006434—
+1K061169Endosseous Dental ImplantNorthern Implants, LLC200624—
+1K060062Straumann OrthosystemInstitut Straumann AG200612
+1K033984Straumann Dental Implant SystemInstitut Straumann AG2004376—
+2K230108Straumann® BLC and TLC ImplantsInstitut Straumann AG20234—
+2K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+2K190048UF (II) Anatomic abutmentDio Corporation20190—
+2K182313BoneTrust Implant SystemMedical Instinct Deutschland GmbH20190—
+2K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+2K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+2K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+2K150388Dental Implant SystemBio Concept Co., Ltd.20151—
+2K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+2K143539Dental Implant OKTAGON Bone LevelHager& Meisinger GmbH20158—
+2K142751Chang Gung ComMed Series Dental Implant SystemChang Gung Medical Technology Co., Ltd.20150—
+2K142167Medentika Abutment SystemMedentika GmbH20157—
+2K142667Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC 4.0x8.5mm, Stern AC…Sterngold Dental, LLC20150—
+2K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc.2014109—
+2K140878Straumann Bone Level Tapered ImplantStraumann USA, LLC20141052
+2K122988Klockner Dental Implant AbutmentsSoadco, S.L.20139—
+2K130808Straumann Healing Abutments, Healing Caps, Closure ScrewsStraumann USA201339—
+2K130216Atlantis Straumann Bone Level AbutmentDentsply Implant20130—
+2K130222Straumann Dental Implant SystemStraumann USA, LLC2013118—
+2K112787KeratorKj Meditech Co., Ltd.20123—
+2K121131BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MMStraumann USA20121241
+2K111421Sirona Dental Cad/Cam SystemSirona Dental Systems GmbH201254—
+2K102034Blue Sky Bio Dental Implant SystemBlue Sky Bio, LLC20114—
+2K093749GC Aadva Implant SystemGC America, Inc.20100—
+2K092261Defcon Tsa/TSH Dental Implant SystemImpladent, S.L.20100—
+2K093643Multi- Unit Abutments for Straumann and Astra Tech Implant SystemsNobel Biocare AB201034—
+2K093615Spi Dental Implant, ElementThommen Medical AG20101—
+2K091701Straumann Modified Dental AbutmentInstitut Straumann AG200911—
+2K083871Atlantis Straumann Bone Level Abutment, Atlantis Gemini Straumann Bone Level Abutment…Astra Tech, Inc.20094—
+2K083192Inclusive Titanium Abutment BlanksInclusive Dental Solutions200940—
+2K083550Straumann Dental Implant SystemStraumann USA2009228—
+2K072425Jne Implant SystemGC America, Inc.20081—
+2K072917JJG Evolution Orthodontic Implant SystemOdontit S.A.20080—
+2K071888Straumann P.004 RC Gold Abutment for BridgesStraumann USA20071—
+2K072679P.004 AbutmentsInstitut Straumann AG2007279—
+2K072497P.004 NC Gold Abutment for CrownsInstitut Straumann AG2007224—
+2K071919P.004 AbutmentsStraumann USA (On Behalf of Institut Straumann Ag)20070—
+2K071357P.004 NC Anatomic AbutmentsInstitut Straumann AG2007114—
+2K070478P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap)Straumann Manufacturing, Inc.2007283—
+2K072151P.004 RC Cares Titanium and Ceramic AbutmentsStraumann USA20072641
+2K070549Straumann P.004 RC Gold AbutmentInstitut Straumann AG2007225—
+2K072071Straumann P.004 Cementable Abutments, Temporary Copings and Protective CapsInstitut Straumann AG2007205—
+2K071585P.004 Healing Abutments and Closure ScrewsStraumann USA20072331
+2K070841Endosseous Dental Implant SystemSouthern Implants, Inc.200721—
+2K070905Endosseous Dental Implant SystemSouthern Implants, Inc.2007171
+2K063364Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd.2007187—
+2K053088Slactive ImplantsInstitut Straumann AG2006295—
+2K040757Sic ProSic Invent AG20052—
+3K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+3K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+3K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+3K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+3K241183ISO AbutmentSeum Medi Co., Ltd.20250—
+3K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+3K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+3K241575Straumann® Anatomic Healing Abutments XC (AHA)Straumann USA, LLC202401
+3K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+3K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+3K231566ICX-Implant SystemMedentis Medical GmbH20240—
+3K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+3K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+3K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+3K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+3K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+3K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+3K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+3K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+3K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+3K212364BLT Dental Implant SystemBio Concept Co., Ltd.20220—
+3K213576Tatum Surgical Dental Implant SystemSuncoast Dental, Inc. Dba Tatum Surgical20221—
+3K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+3K212533BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) ImplantsInstitut Straumann AG20221—
+3K212538DESS Dental ImplantsTerrats Medical SL20211—
+3K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+3K202092ABC Dental Implant SystemAbracadabra Implants, Ltd.20210—
+3K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+3K202942Straumann 4 mm Short ImplantsStraumann USA, LLC20210—
+3K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+3K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+3K193592Neodent Implant System - Change in the Shelf Life of Neodent Acqua ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20200—
+3K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+3K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+3K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+3K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+3K182246Mist ICImagine Milling Technologies, LLC20194—
+3K183518Preat AbutmentsPreat Corporation2019223
+3K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+3K181520Sirona Dental CAD/CAM SystemDentsply Sirona20186—
+3K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—