510(k) Report

Devices descending from K945847

570 later devices reach Frialit (R)-2 Stepped Screw with Deep Profile Surface through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K231434DESS Dental Smart SolutionsTerrats Medical SL20230—
+7K221107TRUSTRgorithm Korea20230—
+7K222026Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+7K223638Neodent Implant System - Helix Short Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20230—
+7K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)Dental Direkt GmbH20230—
+7K221402CEREC Tessera Abutment Block, CEREC Tessera Abutment SystemDentsply Sirona, Inc.20232—
+7K220562TiGEN Abutment, ZrGEN Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20225—
+7K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+7K222215IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20224—
+7K221966Dynamic TiBaseTalladium Espana, SL20225—
+7K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+7K220200Paltop Conical Implant SystemPaltop Advanced Dental Solutions, Ltd.20222—
+7K203660TRI-matrix Implant LineTri Dental Implants Int. AG20213—
+7K212664SherlockOpen Implants, LLC20212—
+7K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20215—
+7K212108Dynamic TiBaseTalladium España, SL20219—
+7K210336Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+7K211225MIS Ti-base abutmentDentsply Sirona20210—
+7K203309NUVO CF Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20215—
+7K203725S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20218—
+7K210855Straumann BLX Implant SystemInstitut Straumann AG20210—
+7K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda20210—
+7K203382Neodent Implant System-Easy PackJjgc Industria E Comercio DE Materiais Dentarios S.A.202102
+7K202282Neodent Implant System - Zirconia Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S.A.20212—
+7K202269PRE-MILLED AbutmentMit Global Co., Ltd.20200—
+7K193193Telio CAD Abutment Solutions- extra systemsIvoclar Vivadent, AG20200—
+7K193401Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE ImplantsAltatec GmbH20209—
+7K201225Neodent Implant System - GM Helix Implants 7.0Jjgc Industria E Comercio DE Materiais Dentarios S.A.20201—
+7K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+7K200355Duranext AbutmentsElegant Dental Corp.20200—
+7K200867Implantswiss Dental Implant System and Implantswiss Dental Abutment SystemNovodent SA20200—
+7K192401Straumann Screw-Retained AbutmentsStraumann USA, LLC20202—
+7K193529ATLANTIS Abutment for MIS Conical Connection ImplantsDentsply Sirona20203—
+7K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+7K191256Straumann BLX Ø3.5 mm ImplantsInstitut Straumann AG20190—
+7K191191Neodent Implant System - Temporary AbutmentsJjgc Industria E Comercio DE Materiais Dentarios S.A.20190—
+7K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+7K190718Zygomatic ImplantsJjgc Industria E Comercio DE Materiais Dentarios S.A.20192—
+7K182228MIS LOCKiT Abutments System, OT-Equators and Ball AttachmentsMis Implants Technologies, Ltd.20190—
+7K181037DIO CAD/CAM AbutmentDio Corporation20187—
+7K180536Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20182—
+7K180609Rodo SmilekeyRodo Medical, Inc.20180—
+7K172430ArgenIS Titanium AbutmentsArgen Corporation20180—
+7K173902Neodent Implant System – GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.20183—
+7K173379Straumann Variobase for Crown ASInstitut Straumann AG20180—
+7K171799Elos Accurate Customized Abutment, Elos Prosthetic ScrewElos Medtech Pinol A/S201815—
+7K171757Straumann Screw Retained AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)201714—
+7K170394Kisses MiniAchimhai Medical Corporation20170—
+7K170838Medentika CAD/CAM TiBasesMedentika GmbH20174—
+7K170354Straumann Variobase AbutmentsInstitut Straumann AG20170—
+7K170356Straumann Variobase AbutmentsInstitut Straumann AG20172—
+7K162390ET Hybrid AbutmentHiossen, Inc.20172—
+7K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+7K160784CAM Titanium BlanksAltatec GmbH20161—
+7K153064Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20161—
+7K153779Abutment for BridgesAltatec GmbH20161—
+7K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+7K152509CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR)Altatec GmbH20160—
+7K151324Straumann Variobase for CERECStraumann USA, LLC201513—
+7K151247NC Straumann Screw Retained AbutmentsStraumann USA, LLC20150—
+7K150814Straumann Screw-Retained AbutmentStraumann USA, LLC20150—
+7K151157NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for…Straumann USA, LLC20151—
+7K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—
+7K140737Straumann Cares Screw Retained Bars/BridgeStraumann USA, LLC20140—
+7K141871Straumann Bone Level NC Angled Screw Retained AbutmentsStraumann USA, LLC20142—
+7K133551Zimmer ZFX Titanium Base Abutment for Tapered Screwvent Implant SystemZimmer Dental, Inc.20140—
+7K123491Biodenta Dental Implant System - Multi-Use AbutmentBiodenta Swiss AG201311—
+7K122559Biodenta Dental Implant System - AbutmentsBiodenta Swiss AG20130—
+8K262207Cemented Plus AbutmentUnidental Co., Ltd.20260—
+8K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+8K261122Mist ICImagine Milling Technologies, LLC20260—
+8K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+8K252727Neodent InLab Validated WorkflowJJGC Indústria e Comércio de Materiais Dentários S.A.20260—
+8K252248CEREC Tessera Abutment SystemDentsply Sirona20250—
+8K243983Paltop Dental Implant SystemPaltop Advanced Dental Solutions, Ltd.20250—
+8K251647MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+…Dentsply Sirona, Inc.20250—
+8K251297MIS LYNX Conical Connection Implant SystemDentsply Sirona, Inc.20250—
+8K250081Atlantis® Abutments in TitaniumDentsply Sirona20252—
+8K242661TRI-matrix® X-Force ImplantsTri Dental Implants Int. AG20250—
+8K242025Elos Accurate® Hybrid Base™Elos Medtech Pinol A/S20242—
+8K241170Dynamic TiBase; TRI ScrewsTalladium España, SL20240—
+8K240725PreXolid CAD/CAM abutmentsEclectic Co., Ltd.20240—
+8K240262BTI Interna 3.0 Dental Implant System UnicCa®B.T.I. Biotechnology Institute, Sl.20240—
+8K234142TiGEN Abutment, PMMA Abutment and Scan Healing AbutmentMegagen Implant Co., Ltd.20240—
+8K241722Elos Accurate® Hybrid Base™; Elos Accurate® Customized AbutmentElos Medtech Pinol A/S20240—
+8K233389EK Digital AbutmentsHiossen, Inc.20240—
+8K234018CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment SystemDentsply Sirona20240—
+8K233857Neodent Implant System – Custom AbutmentsJJGC Indústria e Comércio de Materiais Dentários S.A.20242—
+8K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+8K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+8K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+8K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+8K231559Multi-Unit DAS SystemTalladium España, SL20231—
+8K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+8K232151Dynamic TiBaseTalladium España, SL20232—
+8K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L.20233—
+8K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+8K221673Bonafix TiBaseZentek Medical, LLC20231—
+8K223663SIMDA AbutmentSimda Co., Ltd.20232—
+8K222636ET Abutment SystemHiossen, Inc.20230—