510(k) Report

Devices descending from K052997

245 later devices reach Zimmer Dental One-Piece Implant through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K181381A.B. Dental Devices Dental Implants SystemA.B. Dental Device, Ltd.20180—
+5K172430ArgenIS Titanium AbutmentsArgen Corporation20180—
+6K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+6K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+6K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+6K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+6K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+6K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+6K243009Mist ICImagine Milling Technologies, LLC20251—
+6K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+6K243824Preat AbutmentsPreat Corporation20250—
+6K243278Custom AbutmentsInstitut Straumann AG202501
+6K242379LL Implant SystemOssvis Co., Ltd.20240—
+6K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+6K221315UNIdental Symphony Implant SystemUnidental Co., Ltd.20231—
+6K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+6K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+6K222836Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discsInstitut Straumann AG202301
+6K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+6K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+6K212664SherlockOpen Implants, LLC20212—
+6K212108Dynamic TiBaseTalladium España, SL20219—
+6K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+6K201681Straumann Immediate Temporary AbutmentsInstitut Straumann AG20210—
+6K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+6K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+7K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+7K261122Mist ICImagine Milling Technologies, LLC20260—
+7K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+7K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+7K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+7K221673Bonafix TiBaseZentek Medical, LLC20231—
+7K221966Dynamic TiBaseTalladium Espana, SL20225—
+7K220482SherlockOpen Implants, LLC20221—
+8K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+8K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+8K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+8K250967SherlockOpen Implants, LLC20250—
+8K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+8K231559Multi-Unit DAS SystemTalladium España, SL20231—
+8K232151Dynamic TiBaseTalladium España, SL20232—
+9K243732Multi-Unit DAS SystemTalladium España, SL20260—
+9K243530Dynamic TiBaseTalladium España, SL20250—
+9K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+10K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—