510(k) Report

Devices descending from K002188

395 later devices reach Swissplus Implant System, Model SPWB 8,10,12,14/OPH20/SMPR, SPB… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K222451Save GBRDentis Co., Ltd.20230—
+7K220517IBS SystemInnobiosurg Co., Ltd.20220—
+7K222368Mist ICImagine Milling Technologies, LLC20222—
+7K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+7K222269DESS Dental Smart SolutionsTerrats Medical SL20223—
+7K220823Preat AbutmentsPreat Corporation202216
+7K210354SNUCONE Bone Level Implant SystemSnucone Co., Ltd.20220—
+7K220440Dentis s-Clean Abutment MiniDentis Co., Ltd.20220—
+7K213506NB 1 SA Implant SystemArum Dentistry Co., Ltd.20225—
+7K201323INNO SLA Submerged Implant SystemCowellmedi Co., Ltd.20222—
+7K210039CORE1 Implant SystemCybermed, Inc.20220—
+7K210499Alpha Dent Implants Dental Implants SystemAlpha Dent Implants GmbH20211—
+7K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+7K210080Dentis s-Clean s-Line MiniDentis Co., Ltd.20210—
+7K210134Dentis s-Clean s-LineDentis Co., Ltd.20212—
+7K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+7K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+7K202418Magic UCLA Abutment SystemInnobiosurg Co., Ltd.20202—
+7K192294I DoI DO Biotech Co., Ltd.20200—
+7K192747Yxoss CBR®Reoss GmbH20200—
+7K200753IBS Implant System IIInnobiosurg Co., Ltd.20201—
+7K200099s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20201—
+7K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+7K193335SherlockOpen Implants, LLC20203—
+7K190641AR_N SLA Type Implant SystemBiotem Co., Ltd.20200—
+7K191919Elos Accurate Hybrid BaseElos Medtech Pinol A/S202011—
+7K192688s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20203—
+7K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+7K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+7K173570SD AbutmentSurgident Co., Ltd.20190—
+7K181854OssBuilder SystemOsstem Implant Co., Ltd.20190—
+7K171694s-Clean TiN Coating AbutmentsDentis Co., Ltd.20172—
+7K161923J2A SLA Dental Implant SystemKj Meditech Co., Ltd.20171—
+7K170259TruAbutment DSTruabutment201717—
+7K170220OneQ-SL s-Clean Implant SystemDentis Co., Ltd.20170—
+7K160536Chaorum Implant SystemMedimecca Co., Ltd.20173—
+7K101096HT Iii SA Fixture SystemHiossen, Inc.2010104—
+8K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+8K253493Dentis SQ-SL AXEL FixtureDentis Co., Ltd.20260—
+8K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+8K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+8K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+8K243009Mist ICImagine Milling Technologies, LLC20251—
+8K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+8K243824Preat AbutmentsPreat Corporation20250—
+8K242542Medentika CAD/CAM AbutmentsMedentika GmbH20250—
+8K241703SD Implant SystemArum Dentistry Co., Ltd.20250—
+8K240435Alpha Dent Implants Dental Implants SystemAlpha Dent Implants GmbH20240—
+8K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+8K231932TDS (Techwin Dental System)Techwin Co., Ltd.20240—
+8K240511Dentis s-Clean SQ-SL FixtureDentis Co., Ltd.20240—
+8K230307Dentis i-Clean SystemDentis Co., Ltd.20230—
+8K230725NB Implant SystemArum Dentistry Co., Ltd.20231—
+8K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+8K222131NB 1 SA Implant SystemArum Dentistry Co., Ltd.20221—
+8K202046LOTA SLA Dental Implant System and LOTA HA Dental Implant SystemKj Meditech Co., Ltd.20220—
+8K211978JplantJj Medical Co., Ltd.20220—
+8K212664SherlockOpen Implants, LLC20212—
+8K212108Dynamic TiBaseTalladium España, SL20219—
+8K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+8K202773s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20210—
+8K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+8K210132s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20210—
+8K202039Honorst Implant SystemMedimecca Co., Ltd.20200—
+8K191913TruAbutment DSTruabutment, Inc.20200—
+8K172304TruAbutment DSTruabutment, Inc.20188—
+8K112532ET II Bio-SA Fixture SystemHiossen, Inc.201210—
+9K261122Mist ICImagine Milling Technologies, LLC20260—
+9K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+9K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+9K221673Bonafix TiBaseZentek Medical, LLC20231—
+9K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+9K221966Dynamic TiBaseTalladium Espana, SL20225—
+9K220482SherlockOpen Implants, LLC20221—
+9K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+9K201842TruBase STruabutment, Inc.20210—
+9K183106TruAbutment DSTruabutment, Inc.20207—
+10K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+10K250967SherlockOpen Implants, LLC20250—
+10K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+10K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+10K231559Multi-Unit DAS SystemTalladium España, SL20231—
+10K232151Dynamic TiBaseTalladium España, SL20232—
+10K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+10K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+11K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+11K243732Multi-Unit DAS SystemTalladium España, SL20260—
+11K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+11K243530Dynamic TiBaseTalladium España, SL20250—
+11K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+11K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+11K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+11K213961TruAbutment DS, TruBaseTruabutment, Inc.20221—
+12K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+13K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—