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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: LBH FDA class 2

    Varnish, Cavity

    Dental

    View full classification →

    Cavity varnish is a dental material applied to the walls and floor of a prepared tooth cavity to seal dentinal tubules, reduce postoperative sensitivity, and protect pulp tissue before placement of a restoration. It is classified as FDA Class 2, indicating moderate risk and the need for 510(k) premarket notification. The product code is LBH, regulated under 21 CFR 872.3260, in the Dental specialty. Third-party review is available for this device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum)
    ReminGel
    CrystLCare™ PRO Biorestorative, Fluoride-Plus
    Jasmate® Toothpaste
    Papacarie Duo
    ProMin Dental Desensitizing Gel
    Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)
    Dental Desensitizer
    3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment
    Apapro Desensitizer
    BioMin Restore Plus
    FiteBac Antimicrobial Cavity Cleanser
    DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (Tutti-Fruity) Flavor, DFV Desensitizing Varnish-Spearmint Flavor, DFV Desensitizing Varnish-Chocolate Flavor, DFV Desensitizing Varnish-Marshmallow Flavor
    Cervitec F
    FiteBac Cavity Cleanser
    FluoroCal
    Restore Toothpaste
    V-varnish Premium
    Oral-B 5% Sodium Fluoride Varnish
    Clinpro Varnish
    LISTERINE Sensitivity Defense Mouthrinse
    VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL
    FLUOR PROTECTOR S
    PROFLUORO FLUORIDE VARNISH
    STARBRIGHT 5% SODIUM FLUORIDE VARNISH
    COLGATE DESENSITIZING MOUTHRINSE, COLGATE SENSITIVE PRO-RELIEF MOUTHWASH
    SYLPHAR REMESENSE SENSITIVITY RELIEF STRIPS
    ENAMELAST
    ALPHA-PRO WHITE VARNISH
    SMARTCOAT 2.5% NAF VARNISH
    SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED)
    PRG BARRIER COAT
    REMESENSE FOR SENSITIVE TEETH
    CAVITY VARNISH
    SENZZZZZ AWAY
    SUPER SEAL TOOTH DESENSITIZER
    PCXX VARNISH
    ACTIV VARNISH
    COLGATE DESENSITIZING DENTAL CREAM
    NUPRO MODEL 13016901
    MI VARNISH
    TOKUYAMA SHIELD FORCE
    ASCENT F-COAT MODEL: 006-00097
    PULPDENT COPAL VARNISH WITH FLUORIDE
    VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH
    PULPDENT FLUORIDE VARNISH
    GLUMA DESENSITIZER POWER GEL
    VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247
    REMESENSE
    FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH

    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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