510(k) Report

Devices descending from K032158

542 later devices reach Xive Dental Implant System Multiple through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K243530Dynamic TiBaseTalladium España, SL20250—
+7K250614Neodent Implant System - Custom AbutmentsJjgc Indústria E Comércia DE Materiais Dentários S.A.20251—
+7K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+7K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+7K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+7K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+7K233587LOCATOR Angled Abutment (Various)Zest Anchors, LLC20244—
+7K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+7K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+7K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+7K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+7K221673Bonafix TiBaseZentek Medical, LLC20231—
+7K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+7K222976MU SystemDentis Co., Ltd.20230—
+7K222984BioClean Implant Restorative SystemBioclean Dental, LLC20220—
+7K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+7K220482SherlockOpen Implants, LLC20221—
+7K220252High Retention Attachment SystemZest Anchors, LLC20221—
+7K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+7K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+7K201842TruBase STruabutment, Inc.20210—
+7K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+7K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+8K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+8K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+8K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+8K250967SherlockOpen Implants, LLC20250—
+8K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+8K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+8K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+8K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+8K231132J & P Click AttachmentsJ & P Dental Technologies20240—
+8K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+8K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+9K242768Customized Abutment and ScrewChengdu Besmile Medical Technology Co., Ltd.20250—
+9K250721LOCATOR® Angled AbutmentZest Anchors, LLC20252—
+9K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+9K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+9K213961TruAbutment DS, TruBaseTruabutment, Inc.20221—
+10K252944LOCATOR® Angled AbutmentZest Anchors, LLC20251—
+10K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—
+11K260555LOCATOR® Angled AbutmentZest Anchors, LLC20260—