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: KLE FDA class 2

    Agent, Tooth Bonding, Resin

    Dental

    View full classification →

    A Resin Tooth Bonding Agent is a dental adhesive material used to bond restorative resins, composite materials, and other dental materials to tooth structure, providing a durable interface between the natural tooth surface and the restoration. It is classified as FDA Class 2, indicating moderate risk requiring 510(k) premarket notification. The product code is KLE and it is regulated under 21 CFR 872.3200 in the Dental specialty. This device is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    HF-Etchant Hydrofluoric Acid Etching Gel
    TopCEM Ceramic Primer Ceramic Coupling Agent
    FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack)
    Ceramic Etchant (HF-5 and HF-9)
    K-Bond Universal
    Light Cure Adhesive
    Peak Universal Bond
    CLEARFIL Universal Bond Quick 2
    DX. Bond V Dental Bonding Adhesive
    Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal
    Hi-Bond Universal
    EZ Bond Universal
    Rainbow 360
    Phosphoric Acid Etching Gel
    DenMat Glutaraldehyde Desensitizer
    UniPrime A, UniPrime E, UniPrime E/C
    Dia-X Bond Universal
    Adhese Universal DC, Cention Primer
    BeautiBond Xtreme
    DIAPLUS Universal
    STEP-1 PumEtch
    PacBond One
    Ultra SEP
    Tokuyama Universal Bond II
    R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose
    Bright Bond Universal
    BZF-29
    Light Cure Dental Adhesive
    EtchPro Etching Gel
    DiaPlus
    DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit
    Ambar, Ambar APS, Ambar Universal APS
    Zipbond
    ADH19
    Visalys Restorative Primer
    Visalys Tooth Primer
    Novidia Universal Bond
    GC Acrylic Primer
    OptiBond eXTRa Universal
    BracePaste MTP Light Cure Primer
    Prime&Bond active Universal Adhesive
    BeautiBond Universal
    Meta P&Bond
    Acid Etchant
    Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel
    TOKUYAMA UNIVERSAL BOND
    Parkell Universal Adhesive
    SHOFU MZ Primer Plus
    RnD TE and RnD SE
    HC Primer

    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.

    Popular Product Codes

    Commonly searched
    DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump