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510(k) Data Aggregation

    K Number
    K980792
    Device Name
    CU-100A LIGHT CURE UNIT
    Manufacturer
    ROLENCE ENTERPRISE CO. LTD.
    Date Cleared
    1998-05-15

    (74 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CU-100A LIGHT CURE UNIT

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

    TO PRODUCE LIGHT FOR FORME MATERIAL SUCH AS LIGHT CURE COMPOSITES, CURE DENTAL RESTORATIVE MATERIAL SUCH AS LIGHT CURE COMPOSITES , CURE DENTAL RESTORATIVE MATERIAL SUCH AS LIGHT CURE COMESSITES , CURE DENTAL SESTORATIVE BONDING AGENTS, ADENTS, ADHESTON PRIMERS ETC. PIT AND FISSURE SEALANTS, BONDING AGENTS, FECTION AND APPEARANCE WHICH ARE APPLIED IN THE RESTORATION OF FUCTION AND APPEARANCE OF THE TEETH OF PATIENT.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental light cure unit. It does not contain information about acceptance criteria or a study that proves the device meets specific criteria. The letter primarily informs the manufacturer that their device, the CU-100A Light Cure Unit, has been determined substantially equivalent to legally marketed predicate devices.

    Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, study details, sample sizes, expert qualifications, or ground truth from the provided text.

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