510(k) Report

Devices descending from K091239

228 later devices reach Astra Tech Implant System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K220482SherlockOpen Implants, LLC20221—
+5K220252High Retention Attachment SystemZest Anchors, LLC20221—
+5K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+5K212108Dynamic TiBaseTalladium España, SL20219—
+5K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+6K261122Mist ICImagine Milling Technologies, LLC20260—
+6K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+6K250967SherlockOpen Implants, LLC20250—
+6K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+6K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+6K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+6K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+6K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+6K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+6K231132J & P Click AttachmentsJ & P Dental Technologies20240—
+6K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+6K221673Bonafix TiBaseZentek Medical, LLC20231—
+7K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+7K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+7K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+7K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+7K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+7K250721LOCATOR® Angled AbutmentZest Anchors, LLC20252—
+7K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+8K252944LOCATOR® Angled AbutmentZest Anchors, LLC20251—
+8K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+9K260555LOCATOR® Angled AbutmentZest Anchors, LLC20260—
+9K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—