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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: EFW FDA class 1

    Toothbrush, Manual

    Dental

    View full classification →

    The Manual Toothbrush is a dental hygiene device used by individuals to mechanically remove plaque and food debris from tooth surfaces and the gingival margin through brushing with dentifrice, helping to prevent caries and periodontal disease. It is classified as FDA Class 1, the lowest risk category, and is GMP exempt, meaning it is also exempt from most good manufacturing practice requirements. The product code is EFW and the applicable regulation is 21 CFR 872.6855, under the Dental medical specialty.

    510(k) Clearances

    49 matches
    K Number
    Device Name
    DENTEK EASY BRUSH WITH FLUORIDE
    BEAM BRUSH/BEAM APP
    SILVER CARE ANITBACTERIAL TOOTHBRUSH
    ORAL-B SUB-BRAND MANUAL TOOTHBRUSH
    ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL
    MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS
    LAZERSMILE, LAZERWHITE
    TOOTHBRUSH WASH
    BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER
    PLAQ-ATAQ-I
    BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH
    CREST TOOTHBRUSH WITH MICROSHIELD
    REACH ANTIBACTERIAL TOOTHBRUSH
    RANIR HI-TECHNOLOGY DENTAL FLOSS
    BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH
    ECO TOOTHBRUSH
    FEEL FRESH TOOTHBRUSH KIT
    ROSOFSKY & ROSS MOUTHSPA ORAL CARE SYSTEM
    ORALCHEK SUPER-SOFT BRUSH
    DOCTOR KOLYNOS TOOTHBRUSH
    HEADS TRUE BRUSH
    IONODENT II (6 VOLTS)
    IONODENT (TOOTHBRUSH)
    XENEX DENTAL ROULETTE
    EZ BRUSH & FLOSS
    SOFSWAB
    QUIK-BRUSH
    CHECK-MATE AND CHECK-MATE [+]
    CARERITE INTERDENTAL BRUSHES, MODELS 3500 & 4500
    THE EXPERIMENTAL
    ODONTO TOOTHBRUSH
    PLAK SMACKER
    REACH* TOOTHBRUSH
    ZACT DENTAL ARCH TOOTHBRUSCH
    DISP. TOOTHBRUSH W/3 G. TUBE OF TOOTHPST
    PORTABLE TOOTHBRUSH KIT (NO SAMPLE)
    DISP. TOOTHBRUSH W/TOOTHPASTE ATTACHED
    PORT. TOOTHBRUSH KIT W/4 G. TOOTHPASTE
    PY-CO-PROX TM DENTAL BRUSH
    TOTE-BRUSH
    DIJI-DENT
    DX TOOTHBRUSH
    PERIODONTIC TOOTHBRUSH, #0126-0190-00
    TOOTHBRUSH, PEDODONTIC, #0126-0188-00
    TOOTHBRUSH, ORTHODONTIC, #0126-0189-00
    TOOTHBRUSH, REACH
    TOOTHBRUSH, PLAK-A-DENT
    DENTAL STAIN REMOVER
    TOOTHBRUSH

    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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