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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: LFD FDA unclassified

    Saliva, Artificial

    Unknown

    View full classification →

    Artificial saliva is a product used to relieve dry mouth (xerostomia) by substituting for or supplementing natural saliva, typically in patients with reduced salivary gland function due to disease, radiation therapy, or medication. This device is currently unclassified by the FDA, meaning it has not been formally assigned a risk class through the standard regulatory classification process. It carries product code LFD and no regulation number or medical specialty has been assigned. No special flags apply to this device.

    510(k) Clearances

    49 matches
    K Number
    Device Name
    CloSYS® Dry Mouth Sensitive Mouth Rinse
    Salivea Dry Mouth Moisturizing Gel (Dry Mouth Moisturizing Gel)
    Caphosol® Artifical Saliva (32 doses sachet box)
    GuruNanda Dry Mouth Oral Rinse and GuruNanda Dry Mouth Oral Spray
    Dentilube Spray
    Oral-B Dry Mouth Oral Rinse
    Oral-B Dry Mouth Oral Rinse
    CVS Health Dry Mouth Spray, OraLabs Dry Mouth Spray
    MucoPEG
    SmartMouth DryMouth Oral Rinse
    Salivea Dry Mouth Mouthwash, Salivea Dry Mouth Mouthspray
    Voutia™
    G•U•M HYDRAL Dry Mouth Oral Gel, G•U•M HYDRAL Dry Mouth Oral Rinse, G•U•M HYDRAL Dry Mouth Oral Spray
    Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist
    TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges
    Hydris™ Oral Rinse
    Lubricity
    Caphosol Artifical Saliva Tablets
    MedActive Oral Gel and Spray
    SalivaMAX
    XEROSTOM SALIVA SUBSTITUTE GEL
    Elevate Moisturizing Spray
    Oral7 Moisturizing Gel, Oral7 Moisturizing Mouthwash, Oral7 Moisturizing Mouth Spray, Oral7 Toothpaste
    ORAMOIST
    BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY
    AIR LIFT/XEROSTOM ARTIFICIAL SALIVA
    DRY MOUTH MOUTHWASH
    BIOTENE MOISTURIZING MOUTH SPRAY FOR DRY MOUTH SYMPTOM RELIEF
    XEROS DRY MOUTH PUMP
    GC ORAL MOISTURIZING GEL
    BIOTENE DRY MOUTH MOUTHWASH, BIOTENE PBF DRY MOUTH MOUTHWASH
    NEUTRASAL
    NEUTRASAL
    VICKS POWERSHOT DRY THROAT & MOUTH RELIEF
    BIOXTRA MOISTURIZING GEL
    ORAL NEUTRALIZER
    MOUTHKOTE ORAL MOISTURIZER, MODEL 50930-098
    ORAL BALANCE LIQUID/ GEL
    TGO SPRAY
    OASIS DRY MOUTH RELIEF DISCS OR OASIS MOUTH MOISTURIZING DISCS
    CAPHOSOL
    SALINUM, ORCLAIR
    SALIVART ORAL MOISTURIZER MODEL NUMBER 03866-009-75 SALIVART ORAL MOISTURIZER MODEL NUMBER 0386-000-25
    CAPHOSOL ARTIFICIAL SALIVA
    GLANDOSANE (SALIVART) SYNTHETIC SALIVA
    MOI-STIR ORAL SWABSTICK(S)
    THROAT MOI-STIR
    SALIVA SUBSTITUTE
    MOI-STIR

    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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