510(k) Report

Devices descending from K955428

324 later devices reach 3I Hydroxylapatite Coated Standard Threaded & Self-Tapping Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K220482SherlockOpen Implants, LLC20221—
+7K220252High Retention Attachment SystemZest Anchors, LLC20221—
+7K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+7K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+7K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+8K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+8K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+8K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+8K250967SherlockOpen Implants, LLC20250—
+8K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+8K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+8K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+8K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+8K233231Dental Implants and AbutmentsDitron Dental, Ltd.20240—
+8K231132J & P Click AttachmentsJ & P Dental Technologies20240—
+8K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+9K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+9K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+9K250721LOCATOR® Angled AbutmentZest Anchors, LLC20252—
+9K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+9K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+10K252944LOCATOR® Angled AbutmentZest Anchors, LLC20251—
+10K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—
+11K260555LOCATOR® Angled AbutmentZest Anchors, LLC20260—