510(k) Report

Devices descending from K031106

227 later devices reach Imtec Sendax Mdi and Mdi Plus Endosseous Implant, Models OB-XX, SH-XX, Mob-22… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+7K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+7K212664SherlockOpen Implants, LLC20212—
+7K212108Dynamic TiBaseTalladium España, SL20219—
+7K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+8K261122Mist ICImagine Milling Technologies, LLC20260—
+8K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+8K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+8K221673Bonafix TiBaseZentek Medical, LLC20231—
+8K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+8K221966Dynamic TiBaseTalladium Espana, SL20225—
+8K220482SherlockOpen Implants, LLC20221—
+9K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+9K250967SherlockOpen Implants, LLC20250—
+9K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+9K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+9K231559Multi-Unit DAS SystemTalladium España, SL20231—
+9K232151Dynamic TiBaseTalladium España, SL20232—
+9K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+10K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+10K243732Multi-Unit DAS SystemTalladium España, SL20260—
+10K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+10K243530Dynamic TiBaseTalladium España, SL20250—
+10K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+10K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+11K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+12K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—