510(k) Report

Devices descending from K130222

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K231566ICX-Implant SystemMedentis Medical GmbH20240—
+1K231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech…Proimtech Saglik Urunleri Anonim Sirketi20240—
+1K212533BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) ImplantsInstitut Straumann AG20221—
+1K202942Straumann 4 mm Short ImplantsStraumann USA, LLC20210—
+1K173908DESS Dental Smart SolutionsTerrats Medical SL201851—
+1K171784Straumann Dental Implant SystemStraumann USA, LLC20184—
+1K170588DESS Dental Smart SolutionsTerrats Medical SL201786—
+1K142167Medentika Abutment SystemMedentika GmbH20157—
+1K140878Straumann Bone Level Tapered ImplantStraumann USA, LLC20141052
+2K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC20260—
+2K260564DESS Dental Smart SolutionsTerrats Medical SL20260—
+2K253312OrangeCAD Med AbutmentsOrangecad Med GmbH20250—
+2K251547DESS Dental Smart SolutionsTerrats Medical SL20251—
+2K243212DESS Dental Smart SolutionsTerrats Medical SL20250—
+2K242340DESS Dental Smart SolutionsTerrats Medical SL20243—
+2K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH20243—
+2K233316DESS Dental Smart SolutionsTerrats Medical SL20248—
+2K223083Straumann SLActive labeling changesInstitut Straumann AG20230—
+2K222288DESS Dental Smart SolutionsTerrats Medical SL202214—
+2K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+2K212628DESS Dental Smart SolutionsTerrats Medical SL202220—
+2K212538DESS Dental ImplantsTerrats Medical SL20211—
+2K212577DESS Dental Smart SolutionsTerrats Medical SL202119—
+2K203464DESS Dental Smart SolutionsTerrats Medical SL202115—
+2K202095CreoDent Solidex Customized Abutment and ScrewCreodent Prosthetics, Ltd.20200—
+2K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+2K191986DESS Dental Smart SolutionsTerrats Medical SL201938—
+2K183138Certain BellaTek Express and BellaTek Flex AbutmentsBiomet 3i20191—
+2K182246Mist ICImagine Milling Technologies, LLC20194—
+2K183518Preat AbutmentsPreat Corporation2019223
+2K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH20192—
+2K160850Nucleoss Tpure Implant SystemSanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti20172—
+2K170287Dental Implants OKTAGON Bone Level Tapered DesignHager& Meisinger GmbH20171—
+2K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC20175—
+2K153758Straumann Bone Level Tapered ImplantsInstitut Straumann AG20160—
+2K150938Straumann® Dental Implant System ¿ Roxolid® SLA ImplantsStraumann USA, LLC201562
+3K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG20260—
+3K253804DESS Dental Smart SolutionsTerrats Medical SL20260—
+3K253341Custom Abutments ASMedentika GmbH20250—
+3K252384DESS® Dental Smart SolutionsTerrats Medical SL20250—
+3K251280DESS® Dental ImplantsTerrats Medical SL20250—
+3K242978Geo AbutmentGeomedi Co,., Ltd.20250—
+3K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+3K232383iPhysio® SystemEuroteknika20250—
+3K240982DESS Dental Smart SolutionsTerrats Medical SL20243—
+3K240603Ti-Base & Master FixArum Dentistry Co., Ltd.20240—
+3K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+3K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+3K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+3K230108Straumann® BLC and TLC ImplantsInstitut Straumann AG20234—
+3K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+3K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+3K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+3K222368Mist ICImagine Milling Technologies, LLC20222—
+3K220823Preat AbutmentsPreat Corporation202216
+3K203240AccelX AbutmentsIntegrated Dental Systems, LLC20212—
+3K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+3K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+3K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+3K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+3K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20208—
+3K193335SherlockOpen Implants, LLC20203—
+3K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+3K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+3K182313BoneTrust Implant SystemMedical Instinct Deutschland GmbH20190—
+3K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+3K180360OKTAGON Implant SystemHager& Meisinger GmbH20180—
+4K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC20260—
+4K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+4K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+4K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+4K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+4K252266S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+4K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+4K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+4K243009Mist ICImagine Milling Technologies, LLC20251—
+4K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+4K243824Preat AbutmentsPreat Corporation20250—
+4K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+4K240187Tapered Pro Conical Implant SystemBioHorizons Implant Systems, Inc.20242—
+4K234049Straumann® BLC and TLC Implants - Line extensionInstitut Straumann AG20240—
+4K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+4K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+4K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+4K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+4K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+4K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+4K230069S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20230—
+4K221453S.I.N. Dental Implant SystemS.I.N. – Sistema DE Implante Nacional S.A.20221—
+4K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+4K212664SherlockOpen Implants, LLC20212—
+4K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+4K212108Dynamic TiBaseTalladium España, SL20219—
+5K261122Mist ICImagine Milling Technologies, LLC20260—
+5K260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.20260—
+5K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+5K243521Conical Ti Base abutmentsBioHorizons Implant Systems, Inc.20250—
+5K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+5K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+5K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—