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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: NXC FDA class 2

    Aligner, Sequential

    Dental

    View full classification →

    The Sequential Aligner (product code NXC) is a dental device used to move teeth by applying continuous gentle force, intended for the orthodontic treatment of minor tooth malocclusion. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 872.5470 within the Dental specialty. Third-party 510(k) review is available, and the device carries no implant or life-sustaining flags.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Smylio Aligners
    SureSmile Aligner (ASSY500020)
    ZSmile System
    Clear Aligner (SCF-3348)
    Primeprint Direct Aligner
    Invisalign® Palatal Expander System
    Invisalign Specifix Attachment System
    Serafin®
    Invisalign System
    Additively Manufactured Aligner Resin
    Clear Miracle
    MEM Clear Aligner System
    LuxCreo Clear Aligner System
    SparkTM Clear Aligner System
    Pearl Clear Aligner
    Fas Aligner System
    Cristaline Aligners Z FLX
    GENIOVA aligners
    Spark™ Clear Aligner System
    Illusion Aligner Pro: Illusion Aligner FLX
    Clear Moves Aligner
    Alien Aligners
    Invisalign System
    DigiLine Direct Print Aligner System
    Clear Moves Aligners
    Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX
    TERA HARZ CLEAR
    Serafin®
    MESHEET
    Invisalign Palatal Expander System
    Byte Aligner System
    3M™ Clarity™Aligners with Quick Attachments
    Invisalign System with Mandibular Advancement Featuring Occlusal Blocks
    TRIOCLEAR System
    Clear Aligner
    3M™ Clarity™ Aligners (3M™ Clarity™ Aligners-Force, 3M™ Clarity™ Aligners-Flex)
    STR8 Clear Aligner
    Custom-made Invisible Aligners
    Nightwear Aligners
    Ensmile
    Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G
    Toothsi, Smilealigners
    Invisalign System, Pre-Formed Attachment System
    Al Smile Aligner
    DentCare Aligners
    Tera Harz Clear
    CREOKORREKT Aligners
    Nuvola
    ClearCorrect System
    MyClearALIGN Dental Aligner System

    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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