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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: DZI FDA class 2

    Drill, Bone, Powered

    Dental

    View full classification →

    The Powered Bone Drill is a dental and oral surgical device used to create holes or channels in bone during oral surgical and implant procedures, driven by a powered mechanism. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) clearance before marketing. The product code is DZI and the applicable regulation is 21 CFR 872.4120, under the Dental medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    49 matches
    K Number
    Device Name
    Implantmed Plus II & Piezomed Plus II Module
    VarioSurg 4
    MT-Bone
    Surgical Drive System (Model: ES70, ES90, E8)
    Guided Surgery Kit
    TRAUS SUS20
    Surgical Drills
    Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip
    PIEZOTOME CUBE
    Piezosurgery White
    PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE
    Oral Surgery System and Accessories
    PIEZOSURGERY WHITE
    TRAUS SUS10
    Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L
    PIEZOMED
    ULTRASONIC SURGERY
    PIEZOSURGERY TOUCH
    ULTRASONIC SURGERY MACHINE
    PIEZOTOME SOLO
    ULTRASONIC SURGICAL UNIT
    PIEZO BONE SURGERY
    PIEZOSURGERY 3; OSSTEM PIEZO
    PIEZOTOME 2
    IMPLANT CENTER 2
    SYNTHES 90 DEGREE SCREWDRIVER
    SURGYBONE
    STRAUMANN GUIDED INSTRUMENTS
    BONART'S ARTEOTOMY OMI AND OPI ULTRASONIC SURGERY SYSTEM & ACCESSORIES
    PIEZO ULTRASONIC DEVICE, MODEL ULTRASONIC BONE SURGERY; ULTRASONIC DEBRIDMENT DEVICE
    VARIOSURG
    EMS PIEZON MASTER SURGERY
    IMPLANT CENTER
    PIEZOTOME
    MICROPOWER HAND PIECE: ORAL MAX HIGH SPEED DRILL
    PIEZOSURGERY DEVICE
    MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55
    POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185
    STRYKER TOTAL PERFORMANCE (TPS) SYSTEM
    STRYKER HERMES-READY TOTAL PERFORMANCE SYSTEM
    AMORPHOUS DIAMOND COATED DRILL
    STRYKER ORAL MAX SYSTEM
    MICROTEK MINI-MAX DRILL SYSTEM
    TMJ CANNULA SET
    ARTUS DRILL #4000
    ARTUS DRILL #6000
    ARTUS DRILL #3000
    ARTUS DRILL #2000
    MONOJECT ENDOSSEOUS DENTAL IMPLANT TOOL

    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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