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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: EJF FDA class 1

    Bracket, Metal, Orthodontic

    Dental

    View full classification →

    The Metal Orthodontic Bracket is a small metal attachment bonded to the tooth surface as part of a fixed orthodontic appliance, designed to receive and retain the archwire that applies forces to move teeth into the desired position. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EJF, regulated under 21 CFR 872.5410 in the Dental (DE) specialty.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    BITEM LOCK, MODELS SW006, SW012
    MICROARCH GOLD BRACKET
    ALASTIK
    MEMORY WIRE
    ORTHOTECH DURA-GOLD BARCKETS
    FASCINATION CERAMIC BRACKET
    REGENCY BRACKET
    REFLECTIONS
    DENTAURUM METAL BRACKETS
    FORESTADENT ORTHODONTIC BANDS
    LARIAT PALATE EXPANDER
    CHANNEL-EDGE BRACKET SYSTEM
    REGENCY PLUS BRACKET
    ORMCO SPORTSGUARD
    NITANIUM PALATAL EXPANDER
    ION-IMPLANTED NEO SENTALLOY
    PLASTIC CHAIN
    SOLO TIES
    NITANIUM PRO FORM ARCHWIRES,ROUND,SQUARE,RECTANGUL
    FORESTADENT BRACKETS
    THE HERBST APPLIANCE
    APEX DIRECT BONDED BRACKETS
    MEMORY WIRE
    ORTHODONTIC METAL BRACKET
    GERMAN MINI DYNALOCK
    ORTHODONTIC STAINLESS STEEL BRACKET
    GLENROE GOLDEN ORTHODONTIC BRACKET
    REFLECTIONS - CERAMIC DENTAL BRACKET
    ORTHODONTIC ELASTICS BANDS
    MIDAS BRACKET
    REFURBISHED ORTHODONTIC APPLIANCES
    KLEER(TM) ORTHODONTIC BRACKET
    ORTHODONTIC WIRE
    PREDISPENSED ORTHODONTIC CERAMIC BRACKET ADHESIVE
    NONSTAINING ALASTIKS
    RETAINER, SCREW EXPANSION ORTHODONTIC
    BRACKET, METAL, ORTHODOTNIC
    LANCER ORIGINAL, SIERRA, GENERAL PURPOSE
    BUCCAL TUBE, BUCCAL ATTACHMENT
    TITANAL,STERLING SPRING,DUAL FLEX,MEMOREX,BENDALLO
    PERMA MESH
    C.A.T.,SINTERLINE,NATURAL ARCH,MICROTWIN,BIOTORQUE
    NICKEL-TITANIUM ORTHODONTIC TOOTH SEPARATING SPRIN
    OXYGEN, AIR, VACUUM, AND NITROUS COUPLERS
    AURA CERAMIC DENTAL APPLIANCE
    ENDOMETRIAL SAMPLER
    THE MYOLOC SYSTEM
    MODIFIED UNI-STICK PLASTIC LIGATURE
    BIOLASTIC SUPER ELASTIC ARCHES
    FIBERBRAID(TM) BONDED RETAINER

    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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