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510(k) Data Aggregation

    K Number
    K030318
    Device Name
    P2 POLYETHER
    Manufacturer
    HERAEUS KULZER, INC.
    Date Cleared
    2003-04-03

    (63 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    P2 POLYETHER

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    P2 Polyether Impression material is used for inlay, onlay, crown & bridge preparations, functional impressions and implant impressions.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) premarket notification letter from the FDA to Heraeus Kulzer, Incorporated, regarding their P2 Polyether Impression Material. It states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices.

    The document does not contain information about acceptance criteria, device performance tables, sample sizes for test or training sets, data provenance, expert qualifications, ground truth establishment, adjudication methods, or MRMC studies. Therefore, I cannot fulfill your request for that specific information based on the provided text.

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