510(k) Report

Devices descending from K150203

129 later devices reach Medentika CAD/CAM Abutments through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K261122Mist ICImagine Milling Technologies, LLC20260—
+5K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+5K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+5K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+5K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+5K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+5K221673Bonafix TiBaseZentek Medical, LLC20231—
+5K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.202241
+5K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+5K221966Dynamic TiBaseTalladium Espana, SL20225—
+5K220482SherlockOpen Implants, LLC20221—
+6K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+6K251262S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K242768Customized Abutment and ScrewChengdu Besmile Medical Technology Co., Ltd.20250—
+6K251046S.I.N. Dental Implant SystemS.I.N. Implant System Ltda20250—
+6K250967SherlockOpen Implants, LLC20250—
+6K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+6K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+6K231559Multi-Unit DAS SystemTalladium España, SL20231—
+6K232151Dynamic TiBaseTalladium España, SL20232—
+6K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+7K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+7K243732Multi-Unit DAS SystemTalladium España, SL20260—
+7K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+7K243530Dynamic TiBaseTalladium España, SL20250—
+7K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+7K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+8K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+9K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—