510(k) Report

Devices descending from K020646

630 later devices reach Replace HA Coated Implant, Models 35102, 35132, 35162, 43102, 43132, 43162… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+11K223663SIMDA AbutmentSimda Co., Ltd.20232—
+11K222976MU SystemDentis Co., Ltd.20230—
+11K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+11K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+11K220252High Retention Attachment SystemZest Anchors, LLC20221—
+11K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+11K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+12K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+12K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+12K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+12K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+12K231132J & P Click AttachmentsJ & P Dental Technologies20240—
+12K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+12K232271SIMDA abutmentSimda Co., Ltd.20230—
+12K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+12K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+12K201842TruBase STruabutment, Inc.20210—
+12K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+12K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+12K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+13K250721LOCATOR® Angled AbutmentZest Anchors, LLC20252—
+13K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+13K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+14K252944LOCATOR® Angled AbutmentZest Anchors, LLC20251—
+14K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+14K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+14K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+14K213961TruAbutment DS, TruBaseTruabutment, Inc.20221—
+15K260555LOCATOR® Angled AbutmentZest Anchors, LLC20260—
+15K242768Customized Abutment and ScrewChengdu Besmile Medical Technology Co., Ltd.20250—