510(k) Report

Devices descending from K991947

565 later devices reach 3I Ceramic Abutment System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K162390ET Hybrid AbutmentHiossen, Inc.20172—
+7K160784CAM Titanium BlanksAltatec GmbH20161—
+7K153624Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S20160—
+7K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+7K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+7K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+8K261122Mist ICImagine Milling Technologies, LLC20260—
+8K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+8K250967SherlockOpen Implants, LLC20250—
+8K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+8K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+8K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+8K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+8K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+8K241032BellaTek BarsBiomet 3i, LLC20241—
+8K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+8K231132J & P Click AttachmentsJ & P Dental Technologies20240—
+8K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+8K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+8K221673Bonafix TiBaseZentek Medical, LLC20231—
+8K223663SIMDA AbutmentSimda Co., Ltd.20232—
+8K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+8K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+8K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+8K201842TruBase STruabutment, Inc.20210—
+8K192742Straumann Variobase CInstitut Straumann AG20211—
+8K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+8K183106TruAbutment DSTruabutment, Inc.20207—
+8K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+8K171532TruBase STruabutment, Inc.20187—
+8K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+8K170421ET Hybrid AbutmentHiossen, Inc.20180—
+8K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+8K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+9K260940BellaTek BarsZimVie US Corp, LLC20260—
+9K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+9K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+9K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+9K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+9K250721LOCATOR® Angled AbutmentZest Anchors, LLC20252—
+9K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+9K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+9K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+9K232271SIMDA abutmentSimda Co., Ltd.20230—
+9K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+9K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+9K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+9K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+9K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+9K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+9K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+9K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+10K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+10K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+10K252944LOCATOR® Angled AbutmentZest Anchors, LLC20251—
+10K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+10K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+10K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+10K213961TruAbutment DS, TruBaseTruabutment, Inc.20221—
+11K260555LOCATOR® Angled AbutmentZest Anchors, LLC20260—
+11K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+11K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+11K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+12K242768Customized Abutment and ScrewChengdu Besmile Medical Technology Co., Ltd.20250—
+12K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—