510(k) Report

Devices descending from K081666

337 later devices reach Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra Osseospeed 3.0… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+6K221673Bonafix TiBaseZentek Medical, LLC20231—
+6K230523s-Clean Link Abutment NarrowDentis Co., Ltd.20230—
+6K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+6K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+6K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+6K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+6K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+6K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+6K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+6K182143ALFA GATE Dental Implants SystemAlfa Gate Mazen, Ltd.20190—
+6K173343Zygomatic Implant SystemSouthern Implants (Pty), Ltd.20182—
+7K252343Atlantis® Abutments in TitaniumDentsply Sirona20250—
+7K251205Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM ImplantsDentsply Sirona20250—
+7K251294Bonafix Implant AbutmentsZentek Medical, LLC20250—
+7K250721LOCATOR® Angled AbutmentZest Anchors, LLC20252—
+7K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+7K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+7K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+7K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+7K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+7K201842TruBase STruabutment, Inc.20210—
+7K192651ZAGA Zygomatic SystemSouthern Implants (Pty), Ltd.20201—
+8K261327Elos Accurate Hybrid BaseElos Medtech Pinol A/S20260—
+8K251497Elos Accurate Hybrid BaseElos Medtech Pinol A/S20250—
+8K252944LOCATOR® Angled AbutmentZest Anchors, LLC20251—
+8K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+8K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20242—
+8K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+8K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+8K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+9K260555LOCATOR® Angled AbutmentZest Anchors, LLC20260—
+9K242768Customized Abutment and ScrewChengdu Besmile Medical Technology Co., Ltd.20250—
+9K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+9K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+9K213961TruAbutment DS, TruBaseTruabutment, Inc.20221—
+10K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—