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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: EBG FDA class 2

    Crown And Bridge, Temporary, Resin

    Dental

    View full classification →

    The Temporary Crown and Bridge Resin is a dental material used to fabricate provisional restorations that protect prepared teeth and maintain esthetics and function while a permanent prosthesis is being fabricated in the laboratory. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) clearance before marketing. The product code is EBG and the applicable regulation is 21 CFR 872.3770, under the Dental medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    TempFIT Temporary Crown and Bridge Resin
    DentaTOOTH
    Evoblock, Perléon
    TEMP MASTER, PMMA-based dental resin
    PrimmaArt
    Digital Temp
    Premium Teeth Resin
    Fixtemp® C&B 4:1
    dima Print Teeth & Temp
    PMMA BLOCK
    PMMA Blocks for Dental Use
    CURA-Temp
    Hexa-Temp
    UltraPrint-Dental Temp C&B UV
    C&B 5.0 Hybrid
    E-Temp
    PuRE PMMA Disc
    Aidite PMMA
    GR-17 Resin System
    PMMA Block
    FREEPRINT temp
    Structur CAD
    Bright Temporary C&B
    P pro Crown & Bridge
    GC Temp Print
    ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA
    VarseoSmile Temp
    AA temp temporary restoration 3D printing photoreactive resin
    DiaTemp
    DiaTemp Flow
    DENTCA Crown and Bridge
    Portux CAD/CAM Disc
    Ceramill A-Temp
    TurboTemp EZ
    SmarTemp X1
    MD-Temp Plus
    LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2
    EVOLUX CAD/CAM PMMA BLOCKS
    Harvest Dental Polymer Blocks
    Resin for Temporary Crown & Bridge
    TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT
    Fixtemp C&B
    PuRE PMMA Disc
    DD medical polymers
    Vericore Gradient Temporary Disc
    TelioCAD Multi
    DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR
    YAMAHACHI PMMA DISKS
    SuPro 100
    IDODENTINE DISC, IDODENTINE BLOCK

    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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