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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: FZE FDA class 2

    Prosthesis, Nose, Internal

    General, Plastic Surgery

    View full classification →

    An internal nasal prosthesis is a surgically implanted device used to reconstruct or augment the nose following trauma, congenital defects, or surgical resection, providing structural support or cosmetic restoration. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is FZE, regulated under 21 CFR 878.3680, within the General, Plastic Surgery medical specialty. This device is designated as an implant.

    510(k) Clearances

    42 matches
    K Number
    Device Name
    Medicon Epiplating System
    Osseointegrated Fixtures
    HANSON MEDICAL FACIAL IMPLANTS
    NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION)
    MONARCH NASAL IMPLANT
    MONARCH NASAL IMPLANT
    AART NASAL IMPLANT
    PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTS
    NASAL DORSAL SERIES
    SEARE BIOMEDICAL NASAL IMPLANTS
    SILIMED NASAL L SHAPED IMPLANT
    DURALASTIC ANATOMICAL NASAL IMPLANTS
    DURALASTIC ANATOMICAL NASAL IMPLANTS
    IMPLANTECH JEJ PERI-PYRIFORM IMPLANT
    THE NAUTILUS
    SPIRIT RIDGE SILICONE CARVING BLOCK
    SILICONE ELASTOMER MALAR IMPLANT
    PROTHESIS, CHIN, INTERNAL
    PECTORALIS IMPLANT
    SPIRIT RIDGE NASAL IMPLANT
    BA-CPAS
    IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II
    IMPLANTECH DORSAL NASAL IMPLANT
    NASAL DORSUM
    RIZZO NASAL IMPLANT
    BRINK PRE-MAXILLARY IMPLANT
    FLOWERS DORSAL COLUMELLA IMPLANT
    FLOWERS NASAL IMPLANT
    CUI DORSAL COLUMELLA PROSTHESIS
    CUI PREMAXILLARY IMPLANT
    THE NAUTILUS NASAL IMPLANT
    SILASTIC NASAL IMPLANT S-TYPE
    OMEGA DORSAL COLUMELLA IMPLANTS
    POREX(TM) NOSE PROSTHESIS
    BYRON BIVALVE NASAL SPLINTS
    BYRON NASAL SEPTAL BUTTON
    BYRON DORSAL COLUMELLA IMPLANT
    CUI RHINOPLASTY IMPLANTS
    FRANCIS NASAL TUBE
    STRAITH NASAL IMPLANT
    PASTE, PRO CARE PROPHYLAXIS
    PLASTI-PORE SEPTAL BUTTON

    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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