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    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: KIF FDA class 2

    Resin, Root Canal Filling

    Dental

    View full classification →

    Root Canal Filling Resin is a dental material used to seal and fill the root canal system following endodontic treatment, providing an impermeable, biocompatible barrier that prevents reinfection of the canal and supports long-term retention of the treated tooth. It is classified as FDA Class 2, indicating moderate risk; devices in this category are subject to general controls and special controls, and typically require 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is KIF, regulated under 21 CFR 872.3820, within the Dental medical specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    MTA vpt
    Injectable Root Canal Bioceramic Sealer (nRoot SP)
    One-Fil Putty
    AH Plus Endodontic Sealer
    Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP)
    VioSeal
    Injectable Root Canal Bioceramic Sealer (i-MTA SP)
    Vista BC Putty
    Calx-O, Calcium Hydroxide Powder, Calahyd RC, CeraSeal B, MTA, Rootfyx, Sealmax R, Sealmax +
    Injectable Root Canal Bioceramic Sealer (NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5)
    Bioceramic Root Repair Material (C-Root BP)
    One-Fil
    CeraPutty
    Bright MTA Sealer Plus
    Endofill
    iRoot SP Plus
    ADSEAL Plus
    SmartMTA Capsule
    Endocem MTA Premixed Regular
    iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material
    Vista BC Sealer
    CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid
    Injectable Root Canal Bioceramic Sealer
    UltraCal XS
    BioRoot Flow 0.5g, BioRoot Flow 2g
    Sonendo Filling Material 5C
    White Endoseal MTA
    Biodentine XP 500, Biodentine XP 200
    Metapaste Plus
    Metapex Plus
    DiaPaste
    White ENDOSEAL MTA
    EDS Bioceramic Sealer (Bioseal)
    Bio-C Repair Ion+
    DIA-ROOT BIO MTA
    DIA-ROOT BIO Sealer
    Diapaste
    BIO-C Sealer Ion+
    Dia-Proseal
    CeraSeal
    Diapex Plus
    GuttaSil
    MTA2.3 MATERIALS
    BIO-C TEMP
    Sonendo Material A
    BIO-C REPAIR
    ENDOSEAL MTA
    ENDOSOLV
    BIO-C SEALER
    Well-Root ST

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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