510(k) Report

Devices descending from K010348

63 later devices reach Tantalum Beads - Radiographic Marker through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K090581Tantalum Bead Set, Model P003175Halifax Biomedical, Inc.20090—
+1K071810Inion Spinal Graft Containment SystemInion, Ltd.20081—
+1K063422BioaggregateInnovative Bioceramix, Inc.200638—
+1K061066Synergy Hip SystemSmith & Nephew, Inc.200616—
+1K014148Self-Drilling Radiographic MarkerWalter Lorenz Surgical, Inc.20021—
+1K011856Radiographic MarkersEncore Orthopedics, Inc.200117—
+1K012026Trident All Poly CupHowmedica Osteonics Corp.20010—
+2K151360Inion Spinal Graft Containment SystemInion OY20150—
+2K130312Iroot FMInnovative Bioceramix, Inc.20140—
+2K130353Pipeline Total Hip System (Line Extension)Pipeline Orthopedics20131—
+2K111546U2 Hip SystemUnited Orthopedic Corp.2011131
+2K092715Iroot BP PlusInnovative Bioceramix, Inc.20097—
+2K082943Iroot BP, Model Irbp 4609Innovative Bioceramix, Inc.200912—
+2K080917Iroot SPInnovative Bioceramix, Inc.200837—
+2K040990Modification to Self-Drilling Radiographic MarkersWalter Lorenz Surgical, Inc.20040—
+3K261415Injectable Root Canal Sealer (KP-Root SP)Guilin Kevin Peter Technology Co., Ltd.20260—
+3K252890ZenSeal ProKerr Corporation20260—
+3K251465Root canal repair materials (nRoot BP)Enpuno Biotechnology Co., Ltd.20250—
+3K240365Bioceramic Root Repair Material (C-Root BP)Beijing C-Root Dental Medical Devices Co., Ltd.20241—
+3K232299CeraPuttyMeta Biomed Co., Ltd.20230—
+3K231259iRoot SP PlusInnovative Bioceramix, Inc.20230—
+3K213757Endocem MTA Premixed RegularMaruchi20230—
+3K221149U-Motion II Acetabular System-Extension lineUnited Orthopedic Corporation20231—
+3K222992iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material…Innovative Bioceramix, Inc.20220—
+3K212983Injectable Root Canal Bioceramic SealerBeijing C-Root Dental Medical Devices Co., Ltd.20214—
+3K212283BioRoot Flow 0.5g, BioRoot Flow 2gSeptodont20210—
+3K190503CeraSealMeta Biomed Co., Ltd.20192—
+3K181922Sonendo Material ASonendo, Inc.20180—
+3K180185Bio-C RepairAngelus Industria DE Produtos Odontologicos S/A20183—
+3K172833E-XPE Acetabular Components and U-Motion II Acetabular CupUnited Orthopedic Corporation20182—
+3K170175Endoseal MtaMaruchi20188—
+3K172701Bio-C SealerAngelus Industria DE Produtos Odontologicos S/A20181—
+3K162957U2 Femoral HeadUnited Orthopedic Corporation20171—
+3K163585Responsive Orthopedics Total Hip Arthroplasty SystemResponsive Orthopedics, LLC20171—
+3K132626Pipeline Total Hip System (Line Extension)Pipeline Biotechnology20130—
+3K130149U2 Hip System, Expanded Indications for UseUnited Orthopedic Corporation20130—
+3K122185U-Motion II Acetabular SystemUnited Orthopedic Corp.20137—
+3K122504Femoral Heads, 2.5 and 7.5 MM Neck LengthUnited Orthopedic Corporation20123—
+3K102867Iroot FSInnovative Bioceramix, Inc.20102—
+4K262050Vioseal XSpident Co., Ltd.20260—
+4K253948Momentum Acetabular Cup SystemUnited Orthopedic Corporation20260—
+4K243353One-Fil PuttyMediclus Co., Ltd.20251—
+4K242934Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)Longly Biotechnology (Wuhan) Co., Ltd.20240—
+4K241977Injectable Root Canal Bioceramic Sealer (i-MTA SP)Longly Biotechnology (Wuhan) Co., Ltd.20240—
+4K240304Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)Enpuno Biotechnology Co., Ltd.20242—
+4K231480Bright MTA Sealer PlusGenoss Co., Ltd.20230—
+4K221811Vista BC SealerInter-Med, Inc.20220—
+4K221675United U2 femoral head, 22mm delta ceramic headUnited Orthopedic Corporation20220—
+4K212563CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra…Prevest Denpro Limited20220—
+4K202015White ENDOSEAL MTAMaruchi20211—
+4K201799CleaniCalMaruchi20212—
+4K201222Bio-C Repair Ion+Angelus Industria DE Produtos Odontologicos S/A20210—
+4K190537BIO-C Sealer Ion+Angelus Industria DE Produtos Odontologicos S/A20190—
+4K183129Medtronic Total Hip Arthroplasty SystemMedtronic Advanced Energy20190—
+4K170089U-Motion II Acetabular System— Additional sizesUnited Orthopedic Corporation20172—
+4K163441Locking Cage, Full XPE CupUnited Orthopedic Corporation20173—
+4K132455U-Motion II PS+ CupUnited Orthopedic Corp.20133—
+5K251884One-Fil Putty InjectableMediclus Co., Ltd.20250—
+5K250710Injectable Root Canal Bioceramic Sealer (nRoot SP)Enpuno Co., Ltd.20251—
+5K212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)Prevest Denpro Limited20220—
+5K211905UltraCal XSUltradent Products, Inc.20210—
+5K212229White Endoseal MTAMaruchi20210—
+6K253909NeoPEX™ Pre-Mixed Obturation PasteNuSmile, Ltd.20260—