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510(k) Data Aggregation

    K Number
    K123276
    Device Name
    MM-SEAL
    Manufacturer
    MICRO-MEGA SOCIETE ANONYME
    Date Cleared
    2014-03-10

    (507 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRO-MEGA SOCIETE ANONYME

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MM-SEAL is a root canal sealer packaged in a dual syringe used for filling of root canals with gutta percha points for endodontic treatments. MM-SEAL is intended for use by qualified healthcare personnel trained in its use.
    Device Description
    The MM-SEAL is a biocompatible root canal sealer packaged in a dual syringe used for filling of root canals with gutta percha points for endodontic treatments. The device consists of two component (dual syringe) which are mixed before the use in the dental canal, onto a mixing plate with a spatula for 15-20 seconds or until the mixture become creamy and homogeneous. Application: Thoroughly dry canals walls and apply MM-SEAL, avoiding the formation of air bubbles. Do not exceed the apical limit. Dip the tips of dry, disinfected Gutta-percha points in MM-SEAL. Insert one or more points in the root canal and condense the Gutta-percha. MM-SEAL can be used with thermoplasticized gutta-percha or gutta-percha coated obturator techniques. MM-SEAL should not be used expiry date. MM-SEAL is intended for use by qualified healthcare personnel trained in it use.
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    K Number
    K103123
    Device Name
    APEX POINTER+; MEASRUING CABLE, HOOK, LIP CLIP, TOUCH PROBE (ACCESSORIES)
    Manufacturer
    MICRO-MEGA SOCIETE ANONYME
    Date Cleared
    2011-03-10

    (140 days)

    Product Code
    LQY, LOY
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRO-MEGA SOCIETE ANONYME

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The APEX POINTER+ is indicated for root canal and other related dental procedures, to be used by a trained professional in general dentistry.
    Device Description
    The APEX POINTER+ is an electronic apparatus that employs the bio-impedance principal to estimate the position of an endodontic file in the root canal with respect to the apex point.
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    K Number
    K081268
    Device Name
    SONIC AIR MM1500 + (MID), MODEL 50400014
    Manufacturer
    MICRO-MEGA SOCIETE ANONYME
    Date Cleared
    2009-08-10

    (462 days)

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

    MICRO-MEGA SOCIETE ANONYME

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Endodontics canal preparation - canal cleaning
    Device Description
    Not Found
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    K Number
    K042171
    Device Name
    AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100218, 50100230, 50100232
    Manufacturer
    MICRO-MEGA SOCIETE ANONYME
    Date Cleared
    2004-11-10

    (91 days)

    Product Code
    EGS
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRO-MEGA SOCIETE ANONYME

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ax's Endo® handpieces are intended to hold burs or other tools and to transmit power to these via a motor.
    Device Description
    Ax's Endo® handpieces are intended to hold burs or other tools and to transmit power to these via a motor.
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    K Number
    K971350
    Device Name
    SERIES XE, SERIES SE, SERIES TE
    Manufacturer
    MICRO-MEGA SOCIETE ANONYME
    Date Cleared
    1997-06-04

    (55 days)

    Product Code
    EGS
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRO-MEGA SOCIETE ANONYME

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    These contra-angles are intended.for use. on dental motors equipped with a coupling according to ISO Standard 3964. The speed of the motors may not exceed 40 000 RPM. These contra-angles may receive all dental instruments for contra-angles (burs, prophylaxis instruments, endodontic instruments) whose shank is of type 1, such as : determined in ISO Standard 1797. They allow to carry out all low speed dental works Their usage is of course reserved to dentists or hygienists who are duly graduated and entitled to exercise.
    Device Description
    Not Found
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    K Number
    K961275
    Device Name
    SIRIUS 10, 10L, 40, 40L
    Manufacturer
    MICRO-MEGA SOCIETE ANONYME
    Date Cleared
    1997-01-17

    (289 days)

    Product Code
    EFB
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRO-MEGA SOCIETE ANONYME

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K961235
    Device Name
    SIRIUS 180, 180L, 230, 230L
    Manufacturer
    MICRO-MEGA SOCIETE ANONYME
    Date Cleared
    1997-01-08

    (285 days)

    Product Code
    EFB
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRO-MEGA SOCIETE ANONYME

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K961494
    Device Name
    SERIES XE 140XE,40XE,10XE/SERIES SE 140SE,40SE,10SE/SERIES 10TE
    Manufacturer
    MICRO-MEGA SOCIETE ANONYME
    Date Cleared
    1996-06-26

    (69 days)

    Product Code
    EGS
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRO-MEGA SOCIETE ANONYME

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K961076
    Device Name
    MM 324
    Manufacturer
    MICRO-MEGA SOCIETE ANONYME
    Date Cleared
    1996-04-26

    (39 days)

    Product Code
    EFB
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    MICRO-MEGA SOCIETE ANONYME

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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