BEUDAMED
    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: EBZ FDA class 2

    Activator, Ultraviolet, For Polymerization

    Dental

    View full classification →

    The Ultraviolet Activator for Polymerization is a dental device that emits ultraviolet light to initiate and accelerate the curing (hardening) of UV-sensitive dental resins, sealants, and adhesives used in restorative procedures. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) clearance before marketing. The product code is EBZ and the applicable regulation is 21 CFR 872.6070, under the Dental medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Bluemoon
    LED Curing Lights (DB686 HALO)
    LED Curing Light (C01-X, C02-X)
    LOOP™ LED Curing Light System (CLK01)
    Curing Light, Model: MaxCure 9
    BASE290 LED Curing Light
    CL-DP40 (Dr’s Light PRIME), CL-DP40 (Dr’s Light CHOICE)
    Coltolux Comfort LED Curing Light
    LED Curing Light
    CuringPen Dental Curing Light
    LEDEX
    VALO X, VALO X Accessory Lenses
    VALO Grand Corded and Accessory Lenses
    LOOP LED Curing Light System
    D-LUX+
    LED Curing Light
    Cybird LED Curing Light
    LED Curing Light
    SmartLite Pro Modular LED Curing Light
    Bluephase PowerCure
    VALO Grand Corded
    FUSION Plus Curing Light
    Le'Pen
    Dr's Light2
    Cybird LED Curing Light
    LED Curing Light
    Clear Blue Digi LED Curing Light
    Delight, Delight ortho, B&Lite S
    Demi Ultra
    Valiant Curing Light
    LED Curing Light
    Bluephase Style 20i
    LEDEX WL070+
    Premium Plus C01/C02 LED Curing Light
    VALO Grand
    LED Curing Light GT-2000
    CELALUX 3
    Ascent 3D
    Sirius Max Dental Diode Curing Light
    LED Curing Light
    HI-LIGHT, HI-LIGHT PLUS
    LED CURING LIGHT
    FLEXI-LUME LED SYSTEM
    SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE
    LEDEX
    D-LUX
    DEMI ULTRA
    D1 LED CURING LIGHT, SPEC 3, DENTRONIX LED 3000
    BLUEPHASE STYLE
    VALO CORDLESS

    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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