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510(k) Data Aggregation

    K Number
    K081811
    Device Name
    CARE3 PLUS
    Manufacturer
    NAKANISHI, INC.
    Date Cleared
    2009-01-21

    (209 days)

    Product Code
    EFB
    Regulation Number
    872.4200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CARE3 PLUS

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

    Care3 Plus is intended for internal cleaning, i e , purging of old lubricant, for the maintenance of rotating dental and surgical instruments

    NOTE Care3 Plus should be used with only pre-cleaned dental handpieces and before they are sterilized

    Device Description

    Care3 Plus

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental handpiece and accessories called "Care3 Plus." It does not contain information about acceptance criteria or a study proving that the device meets such criteria. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines general regulatory requirements.

    Therefore, I cannot provide the requested information from this document.

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