510(k) Report

Devices descending from K023067

321 later devices reach Imtec Sendax Mdi ORTHO6 and ORTHO8 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+9K230317Elos Accurate Hybrid BaseElos Medtech Pinol A/S20234—
+9K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+9K221673Bonafix TiBaseZentek Medical, LLC20231—
+9K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+9K221966Dynamic TiBaseTalladium Espana, SL20225—
+9K220482SherlockOpen Implants, LLC20221—
+10K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+10K250967SherlockOpen Implants, LLC20250—
+10K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+10K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+10K231559Multi-Unit DAS SystemTalladium España, SL20231—
+10K232151Dynamic TiBaseTalladium España, SL20232—
+10K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+11K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+11K243732Multi-Unit DAS SystemTalladium España, SL20260—
+11K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+11K243530Dynamic TiBaseTalladium España, SL20250—
+11K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+11K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+12K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+13K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—