510(k) Report

Devices descending from K952811

464 later devices reach 3I Oral/Maxillofacial Bone Fixation System: Stainless Steel Bone-Mesh/Plate &… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K240208DESS Dental Smart SolutionsTerrats Medical SL20247—
+7K231915Zfx AbutmentsZfx GmbH - A Company of Zimvie20240—
+7K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+7K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+7K231967ARi ExCon Implant SystemMegagen Implant Co., Ltd.20231—
+7K231127S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20232—
+7K231097Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss®…Prismatik Dentalcraft, Inc.20230—
+7K232099Neodent Implant System - GM Zygomatic Implant SystemJJGC Indústria e Comércio de Materiais Dentários S.A.20230—
+7K230242OsteoCentric Dental Implant SystemOsteoCentric Technologies20230—
+7K223496Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons®…Prismatik Dentalcraft, Inc.20230—
+7K230126Dentis s-Clean Regular AbutmentDentis Co., Ltd.20230—
+7K223339Bone Chamber ImplantMegagen Implant Co., Ltd.20230—
+7K230143DESS Dental Smart SolutionsTerrats Medical SL20231—
+7K221301DESS Dental Smart SolutionsTerrats Medical SL20233—
+7K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH20231—
+7K222368Mist ICImagine Milling Technologies, LLC20222—
+7K222497Zaga Zygomatic SystemSouthern Implants (Pty), Ltd.20220—
+7K220823Preat AbutmentsPreat Corporation202216
+7K213106BTI Interna Dental Implant System UnicCa - Prosthetic ComponentsB.T.I. Biotechnology Institute, Sl.20223—
+7K221966Dynamic TiBaseTalladium Espana, SL20225—
+7K213997Kontact Dental Implant SystemBiotech Dental, Sas20220—
+7K212785Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio…Blue Sky Bio, LLC20223—
+7K220440Dentis s-Clean Abutment MiniDentis Co., Ltd.20220—
+7K220751Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG20221—
+7K210039CORE1 Implant SystemCybermed, Inc.20220—
+7K203808Multi-unit Abutment, Multi-unit Angled AbutmentMegagen Implant Co., Ltd.20210—
+7K212517Magicore SystemInnobiosurg Co., Ltd.20211—
+7K203554AnyOne External Implant SystemMegagen Implant Co., Ltd.20210—
+7K203542Neodent Implant System - Mini Abutment 60°Jjgc Industria E Comercio DE Materiais Dentarios S.A.20210—
+7K210161AnyOne Onestage Implant SystemMegagen Implant Co., Ltd.20210—
+7K210080Dentis s-Clean s-Line MiniDentis Co., Ltd.20210—
+7K210134Dentis s-Clean s-LineDentis Co., Ltd.20212—
+7K201860Elos Accurate Hybrid BaseElos Medtech Pinol A/S202110—
+7K202026Blue Sky Bio CAD-CAM AbutmentsBlue Sky Bio, LLC202011—
+7K193084TIB Abutment SystemSouthern Implants (Pty), Ltd.20203—
+7K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+7K200827LOCATOR R-TxIvory Super Holdco, Incp.20201—
+7K192062Nucleoss T6 Dental Implant SystemSanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST20200—
+7K200586Straumann TLX Implant SystemInstitut Straumann AG20204—
+7K200597Straumann BLX Gold AbutmentsStraumann USA, LLC (On Behalf of Institut Straumann Ag)20200—
+7K200099s-Clean SQ-SL Implant System MiniDentis Co., Ltd.20201—
+7K193335SherlockOpen Implants, LLC20203—
+7K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+7K193274Rodo Abutment SystemRodo Medical, Inc.20200—
+7K192688s-Clean SQ-SL Implant System RegularDentis Co., Ltd.20203—
+7K192893Straumann Ceramic Healing AbutmentsInstitut Straumann AG20201—
+7K192522TSV BellaTek Express and BellaTek Flex AbutmentsBiomet 3i, LLC20190—
+7K192347ST Internal Implant SystemMegagen Implant Co., Ltd.20190—
+7K190491Blue Sky Bio Zygomatic Implant SystemBlue Sky Bio, LLC20190—
+7K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+7K181703Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG20185—
+7K181037DIO CAD/CAM AbutmentDio Corporation20187—
+7K181850Inversa ImplantsSouthern Implants (Pty), Ltd.20180—
+7K181266Implantswiss Dental Implant System, Implantswiss Dental Abutment SystemNovodent SA20181—
+7K173945Straumann SC Variobase AbutmentsInstitut Straumann AG20180—
+7K173706Piccolo Implants and AccessoriesSouthern Implants (Pty), Ltd.20180—
+7K180609Rodo SmilekeyRodo Medical, Inc.20180—
+7K171694s-Clean TiN Coating AbutmentsDentis Co., Ltd.20172—
+7K170394Kisses MiniAchimhai Medical Corporation20170—
+7K170044Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant SystemPrismatik Dentalcraft, Inc.20175—
+7K163640QZA and RS Dental Implant SystemsTrinon Titanium GmbH20170—
+7K170220OneQ-SL s-Clean Implant SystemDentis Co., Ltd.20170—
+7K163088TSIII BA FixtureOsstem Implant Co., Ltd.20170—
+7K160626ATLANTIS Abutment for HIOSSEN ET implantDentsply Sirona20169—
+7K151789LOCATOR F-Tx Attachment SystemZest Anchors, LLC20168—
+7K151039ATLANTIS Abutment for NobelActive 3.0Dentsply International, Inc.20161—
+7K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+7K151599iSy Implant SystemAltatec GmbH20150—
+7K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+7K123988Anyonetm Internal Implant SystemMegagen Implant Co., Ltd.201319—
+7K113539Revois Pro Implant StsyemRiemser Arzneimittel AG20130—
+7K113042Revois Implant SystemRiemser Arzneimittel AG20130—
+8K253774Elos Accurate® Denture Fixation SystemElos Medtech Pinol A/S20260—
+8K252168Straumann® BLC Implants - Indication WideningInstitut Straumann AG20260—
+8K253493Dentis SQ-SL AXEL FixtureDentis Co., Ltd.20260—
+8K251515Solidex® Ti-Links and ScrewsCreoDent Hudson Valley20260—
+8K253253IPDmilled BlanksImplant Protesis Dental 2004, S.L.20260—
+8K252090Pterygoid Indication for GM Helix ImplantsJJGC Indústria e Comércio de Materiais Dentários S.A.20250—
+8K251129S.I.N. Tapered Pro Conical Zygoma Implant SystemS.I.N. Implant System Ltda20250—
+8K250178Adin Customized AbutmentsAdin Dental Implant Systems, Ltd.20250—
+8K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd.20250—
+8K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+8K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+8K243009Mist ICImagine Milling Technologies, LLC20251—
+8K250639DESS Dental Smart SolutionsTerrats Medical SL20250—
+8K243824Preat AbutmentsPreat Corporation20250—
+8K243278Custom AbutmentsInstitut Straumann AG202501
+8K241972Bluediamond ImplantMegagen Implant Co., Ltd.20240—
+8K241616ALLONUS Tech ProstheticsAllonus Tech Co., Ltd.20240—
+8K240803Surgikor Fixation One, Abutment Blanks and AbutmentsSurgikor, LLC20240—
+8K240609S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A.20240—
+8K240511Dentis s-Clean SQ-SL FixtureDentis Co., Ltd.20240—
+8K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+8K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+8K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+8K232170Ti Link AbutmentIzenimplant Co., Ltd.20240—
+8K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+8K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+8K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+8K231559Multi-Unit DAS SystemTalladium España, SL20231—