510(k) Report

Devices descending from K031345

94 later devices reach Nobel Direct, Models 30937, 30938 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133706ZL Microdent Natural Lock Implant SystemZl Microdent-Attachment GmbH & Co. KG20140—
+1K083869BT-Tite CV3, Mini Implant, Mini Single, Slot Implant, Model (S) Dddiii BTICV3, 1, and…Btlock Srl20090—
+1K070857Nobeldirect 3.0-Immediate Load, 3.0 X 13 MM and 3.0 X 15 MMNobel Biocare AB200743—
+1K050970Milo Dental Implant SystemIntra-Lock International20057—
+1K050506Primasolo One-Piece Implants & Healing CapsLifecore Biomedical, Inc.200543—
+2K151970KJ Mini Implant SystemKj Meditech Co., Ltd.20160—
+2K133050One Plus Implant SystemOsseofuse, Inc.20141—
+2K131701Z5MLB, Z5MLCZ-Systems AG20131—
+2K130140Intra-Lock OP Dental ImplantIntra-Lock International20131—
+2K121707Lew Mdi O-Ball Collared Implant,Park Dental Research Corp.20121—
+2K083669OBIEuroteknika20090—
+2K080594MS System (Narrow Ridge)Osstem Implant Co., Ltd.200842—
+2K072768Restore, Stage-1, Renova Primasolo and Primaconnex Dental ImplantsLifecore Biomedical, Inc.200702
+2K051614Primaconnex Internal Connection Implant System, Primaconnex Internal Connection…Lifecore Biomedical, Inc.2005405
+3K221317S-MonoShinhung Mst Co., Ltd.20230—
+3K200386Z5-BLZ-Systems AG20200—
+3K182091Osstem Abutment SystemOsstem Implant Co., Ltd.201930—
+3K160207ATLANTIS ISUS Implant SuprastructuresDentsply International, Inc.20165—
+3K132178Mostdi Dental Implant SystemMostdi Innovations Sdn Bhd20140—
+3K120089Biogenesis Implant SystemBiogenesis Co., Ltd.20130—
+3K112540S-Mini Implant SystemNeobiotech Co., Ltd.20125—
+3K101913Anthofit OI, Anthofit HE, Ossfit and AxiomAnthogyr Sas201131
+3K103020Atlantis Abutment for Keystone Implant, Atlantis Gemini AbutmentAtlantis Components, Inc.20114—
+3K101545Genesis Implant SystemKeystone Dental2010153
+3K083067MS SystemOsstem Implant Co., Ltd.20097—
+3K081226Simpact Implant SystemSimpact, LLC20081—
+3K073032Primaconnex SD Esthetic Contour ZI AbutmentsLifecore Biomedical, Inc.20070—
+3K072241Primaconnex Cad/Cam Abutment SystemLifecore Biomedical, Inc.20077—
+3K062876Primaconnex Ceramic AbutmentsLifecore Biomedical, Inc.20066—
+3K053643Stage- 1 Temporary/Healing Cap, Model 42021-42026Lifecore Biomedical, Inc.20060—
+4K251427EK Multi Angled 30 AbutmentHiossen, Inc.20260—
+4K241127INNO SLA Mini Plus® Implant SystemCowellmedi Co., Ltd.20240—
+4K233194TS Abutment SystemOsstem Implant Co., Ltd.20242—
+4K221866S-Plant Dental Implant SystemNewton Implant Systems, Inc.20242—
+4K232560Angled AbutmentArum Dentistry Co., Ltd.20231—
+4K231429S-Plant Dental Implant SystemIdis Co., Ltd.20230—
+4K223814Genesis ACTIVE Implant SystemKeystone Dental, Inc.20231—
+4K222636ET Abutment SystemHiossen, Inc.20230—
+4K221684Osstem Abutment SystemOsstem Implant Co., Ltd.20220—
+4K211090ZENEX Implant SystemIzenimplant Co., Ltd.20228—
+4K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+4K203360EK Implants and Abutments SystemHiossen, Inc.20227—
+4K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc.20206—
+4K201334Keystone Dental XL Dental Implant SystemKeystone Dental, Inc.20200—
+4K192614Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet AbutmentMegagen Implant Co., Ltd.20200—
+4K181178S-mini active FixtureNeobiotech Co., Ltd.20180—
+4K170394Kisses MiniAchimhai Medical Corporation20170—
+4K161177Axiom PXAnthogyr Sas20170—
+4K163350Multibase Abutments EV and ATLANTIS SuprastructuresDentsply Sirona20174—
+4K161713Dentium CAD/CAM AbutmentsDentium Co., Ltd.20163—
+4K141450AXIOM 2.8Anthogyr Sas201401
+4K131066Axiom RegAnthogyr Sas20142—
+4K123512Biodenta Dental Implant System- Bone Level D 3.0 to 6.0 MMBiodenta Swiss AG20132—
+4K123415Biodenta Dental Implant System- Bone Level TaperedBiodenta Swiss AG20132—
+4K122171MS SA Implant SystemOsstem Implant Co., Ltd.20122—
+4K113003Atlantis (TM) Abutment and Atlantis (TM) Crown Abutment for Keystone Genesis Implant…Astra Tech, Inc.20120—
+4K110778Biodenta Customized AbutmentBiodenta Swiss AG20112—
+4K103339TDS Abutment for Friadent XivePou YU Biotechnology Co., Ltd.20113—
+4K083141Simpact Endosseous Dental Implant SystemSimpact, LLC20080—
+5K253372ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing AbutmentsHiossen, Inc.20260—
+5K251434Healing Abutment SystemOsstem Implant Co., Ltd.20260—
+5K252585ZENEX Implant System_R-SystemIzenimplant Co., Ltd.20261—
+5K251605DIMPLO Implant SystemDIMPLO, Ltd.20250—
+5K243731HEXIM Implant; Samwon General AbutmentsP&A USA20250—
+5K243255URIS Long Implant & AbutmentsTruabutment, Inc.20250—
+5K243002MBA Biotech Implant SystemMBA Biotech Co., Ltd.20250—
+5K240560ZENEX Implant System_LongIzenimplant Co., Ltd.20240—
+5K240232EK D3.3 and Ultra Wide ImplantsHiossen, Inc.20240—
+5K240966Prima Plus Conical Implant SystemKeystone Dental, Inc.20240—
+5K2314268plant Implant SystemHoowon Edi Co., Ltd.20241—
+5K240091NB Mini Implant SystemArum Dentistry Co., Ltd.20240—
+5K221847Ni2 Implant SystemNewton Implant Systems, Inc.20240—
+5K231753Oneday Implant AbutmentOneday Biotech Co., Ltd.20241—
+5K230438URIS Smart Path Implant System & ProstheticTruabutment, Inc.20230—
+5K231411INNO SLA Submerged Hybrid Ti-Base SystemCowellmedi Co., Ltd.20231—
+5K231874AOT & T-L AbutmentTruabutment, Inc.20230—
+5K231395INNO SLA Submerged Narrow Implant SystemCowellmedi Co., Ltd.20231—
+5K221972Warantec Custom AbutmentWarantec Co., Ltd.20230—
+5K222976MU SystemDentis Co., Ltd.20230—
+5K213449DS Implants abutments provided with the EV connectionDentsply Sirona20212—
+5K193064Atlantis suprastructuresDentsply Sirona, Inc.20200—
+5K191201EM SA Implant SystemHiossen, Inc.20191—
+5K171622Dentium Ti-BaseDentium Co., Ltd.20180—
+5K151295Biodenta Customized Abutment - TitaniumBiodenta Swiss AG20151—
+5K150296Biodenta Customized Abutment-HybridBiodenta Swiss AG20150—
+5K133884Biodenta Dental Implant System-Bone Level Tapered D3.0 and L6.5MMBiodenta Swiss AG20141—
+5K131468Denracle Dental AbutmentGreen Dentech Co, Ltd.20140—
+5K121117NDX AbutmentsNational Dentex Corp20120—
+6K253334ZENEX Implant System_Short (R-System)Izenimplant Co., Ltd.20260—
+6K242379LL Implant SystemOssvis Co., Ltd.20240—
+6K231210DGA AbutmentModern Dental Laboratory (Dg) Co., Ltd.20240—
+6K220841PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)Dentsply Sirona20220—
+6K221094OmniTaper EV Dental Implants, DS Implants abutments with EV connectionDentsply Sirona20220—
+6K141159Konus Dental Implant SystemArgon Med. Productions Vertriebs Gesellschaft Mbh20150—