510(k) Report

Devices descending from K081419

142 later devices reach Straumann Dental Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143051ArgenIS Titanium AbutmentsThe Argen Corporation20152—
+1K130222Straumann Dental Implant SystemStraumann USA, LLC2013118—
+1K123784Straumann Dental Implant SystemStraumann USA, LLC2013122—
+1K122855TL 04.1MM RN,S, Slactive Tizr 6, 8, 10, 12, 14, 16MM Dental ImplantsStraumann USA2012123—
+1K093630Biodenta Dental Implant SystemBiodenta Swiss AG201018—
+2K231566ICX-Implant SystemMedentis Medical GmbH20240—
+2K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+2K212533BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) ImplantsInstitut Straumann AG20221—
+2K202942Straumann 4 mm Short ImplantsStraumann USA, LLC20210—
+2K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+2K171784Straumann Dental Implant SystemStraumann USA, LLC20184—
+2K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+2K160248ArgenIS Titanium AbutmentsArgen Corporation20161—
+2K150388Dental Implant SystemBio Concept Co., Ltd.20151—
+2K142557Anker Dental Implant System - SB-III, ST and AT seriesAlliance Global Technology Co., Ltd.20150—
+2K142167Medentika Abutment SystemMedentika GmbH20157—
+2K140878Straumann Bone Level Tapered ImplantStraumann USA, LLC20141052
+2K111003Biodenta Dental Implant System - Bone LevelBiodenta Swiss AG201117—
+3K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+3K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+3K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+3K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+3K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+3K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+3K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+3K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+3K223083Straumann SLActive labeling changesInstitut Straumann AG20230—
+3K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+3K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+3K212364BLT Dental Implant SystemBio Concept Co., Ltd.20220—
+3K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+3K212538DESS Dental ImplantsTerrats Medical SL20211—
+3K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+3K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+3K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+3K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+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—
+3K172430ArgenIS Titanium AbutmentsArgen Corporation20180—
+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—
+3K150938Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsStraumann USA, LLC201562
+3K123491Biodenta Dental Implant System - Multi-Use AbutmentBiodenta Swiss AG201311—
+3K122559Biodenta Dental Implant System - AbutmentsBiodenta Swiss AG20130—
+3K123512Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MMBiodenta Swiss AG20132—
+3K123415Biodenta Dental Implant System- Bone Level TaperedBiodenta Swiss AG20132—
+4K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+4K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+4K253341Custom Abutments ASMedentika GmbH20250—
+4K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+4K251280DESS® Dental ImplantsTerrats Medical SL20250—
+4K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+4K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+4K232383iPhysio® SystemEuroteknika20250—
+4K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+4K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+4K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+4K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+4K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+4K230108Straumann® BLC and TLC ImplantsInstitut Straumann AG20234—
+4K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+4K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+4K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+4K222368Mist ICImagine Milling Technologies, LLC20222—
+4K220823Preat AbutmentsPreat Corporation202216
+4K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+4K203252Multi-unit Abutments for CONELOGBioHorizons Implant Systems, Inc.20218—
+4K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+4K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+4K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+4K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+4K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+4K193335SherlockOpen Implants, LLC20203—
+4K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+4K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+4K182313BoneTrust Implant SystemMedical Instinct Deutschland GmbH20190—
+4K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+4K180360OKTAGON Implant SystemHager& Meisinger GmbH20180—
+4K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+4K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+5K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+5K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+5K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+5K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+5K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+5K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+5K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+5K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+5K243009Mist ICImagine Milling Technologies, LLC20251—
+5K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+5K243824Preat AbutmentsPreat Corporation20250—
+5K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+5K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+5K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+5K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—