BEUDAMED
    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: EBD FDA class 2

    Coating, Filling Material, Resin

    Dental

    View full classification →

    The Resin Filling Material Coating is a dental material applied over a completed resin restoration to improve its surface finish, reduce microleakage, and seal surface imperfections, thereby improving durability and clinical performance of the restoration. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) clearance before marketing. The product code is EBD and the applicable regulation is 21 CFR 872.3310, under the Dental medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    ID LIGHT CURE SYSTEM
    visio.lign color, visio.lign shield
    RODIN Palette Naturalizing Kit
    VITA Akzent LC
    Nano Varnish, Plaquit, Lightpaint on Surface
    SHOFU RESIN GLAZE
    OPTIGLAZE COLOR
    VITA ENAMIC STAINS
    ENAMELITE ACRYSEAL SPRAY SEALANT
    EASY GLAZE
    DURAFINISH ALL-CURE, MODEL S296
    LED PRO SEAL
    PAINT- ON POLISH AGENT
    SURFACE COAT
    G-COAT
    BISCOVER LED
    BISCOVER LV
    PARKELL RESIN GLAZE
    BELLEGLASS POINT 4
    SCULPTING RESIN
    BISCOVER LIQUID POLISH KIT, BISCOVER LIQUID POLISH AND BISCOVER VISCOSITY MODIFIER
    TESCERA GLAZING RESIN, MODEL T-1804, BISCOVER XT, MODEL G-93220P
    UNINHIBITED
    GINDA GUARD
    LUXAGLAZE
    BELLEGLAZE
    CORE-IDE
    FLOWABLE HYBRID
    RENAMEL FLOWABLE COMPOSITE
    IONOSIT BASE LINER
    FOUNDATION HYBRID COMPOSITE
    NO-STICK COMPOSITE INSTRUMENT DIP
    3M ESTHETIC DESIGN SYSTEM (TINTS & MASKING AGENTS)
    AUSTENAL DENTAL COMPOSITE RESIN
    ESPE KETAC-BOND
    PEPSODENT DENTURE ADHESIVE CREAM
    CURAY JOIN DENT DENTIN PRIMER
    CAULK DYCAL LIGHT CURED
    J & J LIGHT CURING DENTIN/ENAMEL BONDING AGENT
    OPAQUE COATING & SURFACE STAIN
    CONCISE 2 SMALL PARTICLE LIGHT CURVED
    CBM, CORE BUILD-UP MATERIAL
    COMMAND BONDING RESIN/GLAZE/OPAQUER
    CONCLUDE COMPOSITE LUTING CEMENT
    MYERSON/KENSON GP POLYMER
    DMG-POLISHABLE COMPOSITE
    ANTERIOR/POSTERIOR RESTORATIVE, BOND
    SCI-PHARM PAINT-ON RESTORATIVE
    COLORANT
    ULTRAFILL- ULTRABOUND

    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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