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510(k) Data Aggregation

    K Number
    K991863
    Device Name
    CUTE-LITE I LIGHT CURE UNIT
    Manufacturer
    ROLENCE ENTERPRISE CO. LTD.
    Date Cleared
    1999-07-19

    (48 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CUTE-LITE I LIGHT CURE UNIT

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

    TO PRODUCE LIGHT RANGE BETWEEN 400 & 500 NM TO POLYMERIZE LIGHT CURED DENTAL RESTORATIVE MATERIAL SUCH AS LIGHT CURE COMPOSITES, PIT AND FISSURE SEALANTS, BONDING AGENTS, ADHESION PRIMERS ETC. 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 510(k) premarket notification approval letter for a dental light cure unit (Cute-Lite I Light Cure Unit). This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment related to an AI or algorithm-driven device.

    The letter is a regulatory approval for a physical medical device (a light cure unit) based on its substantial equivalence to previously marketed devices, following the provisions of the Federal Food, Drug, and Cosmetic Act. It primarily discusses regulatory classifications, general controls, and compliance requirements.

    Therefore, I cannot provide details for the requested questions as the input document does not contain this type of information.

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