510(k) Report

Devices descending from K994376

665 later devices reach Frialit-2 3.4MM Steeped Cylinder Implant with Frios TPS Coating; Frialit-2… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K220440Dentis s-Clean Abutment MiniDentis Co., Ltd.20220—
+8K210039CORE1 Implant SystemCybermed, Inc.20220—
+8K203808Multi-unit Abutment, Multi-unit Angled AbutmentMegagen Implant Co., Ltd.20210—
+8K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+8K203554AnyOne External Implant SystemMegagen Implant Co., Ltd.20210—
+8K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+8K211225MIS Ti-base abutmentDentsply Sirona20210—
+8K210161AnyOne Onestage Implant SystemMegagen Implant Co., Ltd.20210—
+8K210080Dentis s-Clean s-Line MiniDentis Co., Ltd.20210—
+8K210134Dentis s-Clean s-LineDentis Co., Ltd.20212—
+8K203382Neodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A.202102
+8K192742Straumann Variobase CInstitut Straumann AG20211—
+8K202282Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+8K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—
+8K193404UF (II) Bar holder abutmentDio Corporation20200—
+8K200099s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20201—
+8K192688s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20203—
+8K191191Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+8K192347ST Internal Implant SystemMegagen Implant Co., Ltd.20190—
+8K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+8K190299Elos Accurate® Customized AbutmentElos Medtech Pinol A/S201913—
+8K171532TruBase STruabutment, Inc.20187—
+8K180536Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20182—
+8K173968Straumann Variobase for Bridge/Bar CylindricalInstitut Straumann AG20180—
+8K170421ET Hybrid AbutmentHiossen, Inc.20180—
+8K171694s-Clean TiN Coating AbutmentsDentis Co., Ltd.20172—
+8K170022Klockner Vega TiBase for CERECSoadco, S.L.20170—
+8K170220OneQ-SL s-Clean Implant SystemDentis Co., Ltd.20170—
+8K160519Link Abutment for CERECOsstem Implant Co., Ltd.20160—
+8K160964Neodent Implant System - Titanium Base for CERECJjgc Industria E Comercio DE Materiais Dentarios S.A.20160—
+8K123988Anyonetm Internal Implant SystemMegagen Implant Co., Ltd.201319—
+9K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+9K253493Dentis SQ-SL AXEL FixtureDentis Co., Ltd.20260—
+9K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+9K252320SIMDA AbutmentsSimda Co., Ltd.20250—
+9K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+9K250721LOCATOR® Angled AbutmentZest Anchors, LLC20252—
+9K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20241—
+9K240511Dentis s-Clean SQ-SL FixtureDentis Co., Ltd.20240—
+9K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+9K231307Elos Accurate Customized AbutmentElos Medtech Pinol A/S20231—
+9K232271SIMDA abutmentSimda Co., Ltd.20230—
+9K230307Dentis i-Clean SystemDentis Co., Ltd.20230—
+9K223677Titanium Abutment Blank Nobel Biocare N1 TCCNobel Biocare AB20231—
+9K220517IBS SystemInnobiosurg Co., Ltd.20220—
+9K220878Straumann TLX Variobase CInstitut Straumann AG20220—
+9K201197TruAbutment DS, TruBase STruabutment, Inc.20216—
+9K202773s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20210—
+9K210132s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20210—
+9K193425Pre-Milled BlankArum Dentistry Co., Ltd.20204—
+9K191890Elos Accurate Customized AbutmentElos Medtech Pinol A/S20205—
+9K192457Elos Accurate Customized AbutmentElos Medtech Pinol A/S20206—
+9K192229Neodent Implant System- GM Titanium Base for BridgeJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+10K252944LOCATOR® Angled AbutmentZest Anchors, LLC20251—
+10K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20250—
+10K223634Customized AbutmentArum Dentistry Co., Ltd.20233—
+10K202579TruAbutment DS, TruBaseTruabutment, Inc.20214—
+10K201842TruBase STruabutment, Inc.20210—
+11K260555LOCATOR® Angled AbutmentZest Anchors, LLC20260—
+11K242245Customized AbutmentArum Dentistry Co., Ltd.20240—
+11K234112Customized AbutmentArum Dentistry Co., Ltd.20241—
+11K203649TruAbutment DS, TruBaseTruabutment, Inc.20213—
+12K242768Customized Abutment and ScrewChengdu Besmile Medical Technology Co., Ltd.20250—
+12K241485TruAbutment DS; TruBaseTruabutment, Inc.20240—
+12K213961TruAbutment DS, TruBaseTruabutment, Inc.20221—