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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: EIA FDA class 1

    Unit, Operative Dental

    Dental

    View full classification →

    The Operative Dental Unit is a comprehensive dental treatment station that integrates multiple functions including delivery of air, water, and suction; handpiece connections; instrument trays; and patient chair controls, providing the central workstation for dental procedures. It is classified as FDA Class 1 (lowest risk), subject only to general controls. The product code is EIA, regulated under 21 CFR 872.6640 in the Dental (DE) specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Integral Dental Unit
    Integral Dental Units
    Dental Delivery System Series 5 and Dental Delivery System Series 5 Plus
    BDC Dental Unit
    Firstar Dental Unit
    K5
    N2
    Dental unit Model: Mare
    ELEC Master, ELEC Master Dual
    N2
    G7, Dental Operative Unit and Accessories
    Perceptive electric dental motor and control unit
    Infinity Pro, Logic, Quality, Sprint
    A-dec 300, A-dec 500
    Infinity / Infinity Cross Flex Dental Systems
    K3
    Qraypen
    Forest Dental Unit
    P50 Series Dental Operative Unit and Accessories
    K3
    Vanguard Dental Unit
    ESTETICA Dental Treatment Unit and Accessories
    Evogue Dental Unit
    TAURUS C1
    Spirit
    TENEO Dental Treatment Unit and Accessories
    INTEGO Family and Accesories
    UnicLine Mobile
    Dental Unit
    T-8000 THEROZONE UNIT
    S200, S300
    AJAX DENTAL UNIT
    ERGONOMIC PRODUCTS WORKSTATION
    DIPLOMAT
    DENTAL UNIT WITH CHAIR
    ELEVANCE
    TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE
    DYNAMIC DU SERIES PORTABLE DENTAL UNIT
    CS 1200
    AMC-20 PORTABLE DENTAL CART MODEL AMC-20
    CHALLENGE-EVER
    YOBOSHI DENTAL UNIT
    A-DEC 200 DENTAL SYSTEM
    DENTACENTER/EXPEDITION, MODEL SAF-430
    STERN'S S250 NORDAM
    MODEL GDCH-2000
    KODAK 1500 INTRAORAL CAMERA
    VIVID, MODELS 40-A0001, 40-A0004, 40-A0006
    A-DEC 334/335 DELIVERY SYSTEM
    PLANMECA SOVEREIGN

    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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