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510(k) Data Aggregation

    K Number
    K043325
    Device Name
    ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES
    Manufacturer
    ROLENCE ENTEPRISE, INC.
    Date Cleared
    2005-02-11

    (71 days)

    Product Code
    EIA
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROLENCE ENTEPRISE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ZoomCam LD-10 Intraoral Camera and Accessories are indicated for use to provide a image of the mouth before and after the dental procedure, which assists the dentist in describing the dental procedure being performed as well as the results.
    Device Description
    ZoomCam LD-10 Intraoral Camera and Accessories
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    K Number
    K040396
    Device Name
    ULTRASONIC SCALER ELEGANCE MS-10 (25K)
    Manufacturer
    ROLENCE ENTEPRISE, INC.
    Date Cleared
    2004-04-22

    (65 days)

    Product Code
    ELC
    Regulation Number
    872.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    ROLENCE ENTEPRISE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    THE ELEGANCE MS-10 (25K) ULTRASONIC SCALER IS DESIGNED FOR USE IN PROPHYLAXIS TREATMENTS PERIODONTIA , AND OTHER AREAS OF OPERATIVE DENTISTRY.
    Device Description
    Not Found
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