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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: OLR FDA unclassified

    Oral Wound Dressing

    Unknown

    View full classification →

    The Oral Wound Dressing (product code OLR) is an unclassified device reviewed by the Dental (DE) panel that cleared 510(k) review but remains without formal classification, with unclassified status established via a substantial equivalence determination. It is intended to function as a physical barrier for temporary protection of oral mucosal tissue and to provide pain relief. The device is not an implant and is not life-sustaining.

    510(k) Clearances

    41 matches
    K Number
    Device Name
    Curajel™ Oral Gel
    MuCover (proposed name) Oral Wound Dressing
    Dental Cone; Dental Sponge
    Silatrix Oral Gel
    Elemental Granulate
    HealiAid Dental Collagen Wound Dressing
    PerioStom Dental Dressing
    Ora-Aid
    PuraStat-OM
    MucoLock Oral Gel
    Silatrix Oral Gel
    Synvaza Mouth Sore and Wound Rinse, Synvaza II Mouth Sore and Wound Rinse
    Orapeutic
    OraCure
    SUNTOUCH Dental Dressing
    AFTAMED MOUTHWASH; AFTAMED GEL; AFTAMED SPRAY; AFTAMED SHIELD; AFTAMED JUNIOR GEL
    AONGEN DENTAL COLLAGEN MATRIX
    EPISIL
    PERIOPATCH
    PERIOPATCH
    BENACEL
    GELX ORAL GEL
    REXASTOM ORAL EASE
    CARAPASTE ORAL WOUND DRESSING
    ULCELOOCIN ORAL ULCER PATCH
    GENGIGEL MOUTHRINSE
    SOCK IT! ORAL PAIN GEL
    MUGARD MUCOADHESIVE ORAL WOUND RINSE
    HEMCON DENTAL DRESSING, 1 DRESSING, 4 DRESSING, 1 DRESSING, BOX OF 12, 4 DRESSING, BOX OF 12
    ORAMAGIC PLUS ORAL WOUND RINSE
    ALOCLAIR ORAL SPRAY
    MUCOTROL CONCENTRATED ORAL GEL WAFER
    ALOCLAIR ORAL GEL
    ORAMAGICRX ORAL WOUND RINSE
    ALOCLAIR ORAL RINSE
    GELCLAIR CONCENTRATED ORAL GEL
    THE SALICEPT ORAL PATCH
    ALOE THERAPY ORAL RINSE
    RADIACARE ORAL WOUND RINSE
    CASRRASYN ORAL WOUND DRESSING
    CARRASYN ORAL WOUND DRESSING

    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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