510(k) Report

Devices descending from K050705

532 later devices reach Tiunite Implants through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+8K223663SIMDA AbutmentSimda Co., Ltd.20232—
+8K222976MU SystemDentis Co., Ltd.20230—
+8K222044Elos Accurate Customized AbutmentElos Medtech Pinol A/S20224—
+8K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+8K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+8K220252High Retention Attachment SystemZest Anchors, LLC20221—
+8K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+8K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+9K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+9K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+9K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+9K243272LOCATOR Angled AbutmentZest Anchors, LLC20253—
+9K231132J & P Click AttachmentsJ & P Dental Technologies20240—
+9K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+9K232271SIMDA abutmentSimda Co., Ltd.20230—
+9K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+9K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+9K201842TruBase STruabutment, Inc.20210—
+9K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+9K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+9K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+10K250721LOCATOR® Angled AbutmentZest Anchors, LLC20252—
+10K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+10K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+11K252944LOCATOR® Angled AbutmentZest Anchors, LLC20251—
+11K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+11K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+11K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+11K213961TruAbutment DS, TruBaseTruabutment, Inc.20221—
+12K260555LOCATOR® Angled AbutmentZest Anchors, LLC20260—
+12K242768Customized Abutment and ScrewChengdu Besmile Medical Technology Co., Ltd.20250—