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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: ELW FDA class 2

    Material, Impression

    Dental

    View full classification →

    Dental Impression Material is a substance used to create an accurate negative reproduction of the oral structures, including teeth and surrounding soft tissues, that is subsequently poured with stone or plaster to produce a positive working cast used for fabricating dental restorations and appliances. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket clearance. The product code is ELW, regulated under 21 CFR 872.3660 in the Dental (DE) specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    JET BITE; JET BLUE BITE FAST; JET BLUE BITE SUPERFAST
    Elastic Impression Material
    Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator
    Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu
    DentMix VPS Impression Material
    No Stress Impress
    Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty
    DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast)
    Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration)
    Dental Impression Material
    IMICRYL Impression Materials
    Permadyne
    PRESIDENT The Original
    Dental Impression Material
    VPS Impression Material
    HySil Plus Impression Materials
    Impression Material
    A-Silicone for Bite Registration
    Lascod Impression Materials
    HySil Super Fast Impression Materials
    StoneBite and StoneBite scan
    VPS Impression Material
    Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite
    HySil Impression Materials
    AIM2
    PEAK NS033CF, PEAK NS017CF
    Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono
    Rapid HB, Rapid LB, Rapid MB
    HygePLUS Alginate Impression Material
    HySil Impression Materials
    Vonflex S
    i-Sil
    Image Fast Set, Image Regular Set
    Identic and KromaFaze Alginate Dental Impression Materials
    NoCord
    CharmFlex
    Aquasil Ultra + Smart Wetting Impression Material
    Vonflex S Putty
    Star+ VPS Scannable Impression Material
    Cavex Cream Alginate
    PEAK
    Hyflex Heavy, Hyflex Mono, Hyflex Light
    Elements
    Accu-Dent XD Tray, Accu-Dent XD Syringe
    DentiAnn Smart Sil
    MARK3
    VONFLEX S BITE
    SILDENT
    FLASH PENTA MB QUICK, FLASH MB QUICK
    ELASTIC IMPRESSION MATERIAL

    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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