LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K033020
    Device Name
    IMPAK ACRYLIC REPAIR RESIN LIQUID
    Manufacturer
    CMP INDUSTRIES LLC.
    Date Cleared
    2003-12-19

    (84 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    IMPAK ACRYLIC REPAIR RESIN LIQUID

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

    CMP' IMPAK denture relining, repairing/rebasing liquid resin is indicated for relining a denture surface which contains tissue, for repairing a fractured denture, or forming a new denture base.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental device. It does not contain information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, or ground truth establishment. This type of information is typically found in the 510(k) summary or in the actual premarket notification submission, but not in the clearance letter itself.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1