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510(k) Data Aggregation

    K Number
    K123139
    Device Name
    ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES
    Manufacturer
    ASI MEDICAL, INC.
    Date Cleared
    2013-03-28

    (174 days)

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

    ASI MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ASI 'Advanced Endodontic System - Designer Series (Models 2133E, 2134E, 2115E, 2125E)' is a self-contained dental treatment unit that contains a built in air compressor, vacuum system and water supply. It is designed to provide air, water, vacuum and electricity to operate various dental handpieces, accessories and attachments and to serve as a base for other dental devices and accessories. The device is intended for use to provide general dental restorative care and hygiene procedures in both traditional dental office settings and/or mobile applications by or under the supervision of a licensed dentist or a hygienist if permitted by applicable law
    Device Description
    The ASI 'Advanced Endodontic System - Designer Series (Models 2133E, 2134E, 2115E, 2125E)' is a self-contained dental treatment unit that contains a built in air compressor, vacuum system and water supply. It is designed to provide air, water, vacuum and electricity to operate various dental handpieces, accessories and attachments and to serve as a base for other dental devices and accessories.
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    K Number
    K110481
    Device Name
    TRITON SELF CONTAINED DENTAL SYSTEM, TRITON SELF CONTAINED DENTAL SYSTEM, WITH CASE
    Manufacturer
    ASI MEDICAL, INC.
    Date Cleared
    2012-04-05

    (412 days)

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

    ASI MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The ASI Triton Mobile Dental System (Models 2025 and 2025M) is a self-contained dental treatment unit that contains a built in air compressor, vacuum system and water supply. It is designed to provide air, water, vacuum and electricity to operate various dental handpieces, accessories and attachments and to serve as a base for other dental devices and accessories. The device is intended for use to provide general dental restorative care and hygiene procedures in both traditional dental office settings and/or mobile applications by or under the supervision of a licensed dentist or a hygienist if permitted by applicable law.
    Device Description
    The ASI Triton Mobile Dental System (Models 2025 and 2025M) is a self-contained dental treatment unit that contains a built in air compressor, vacuum system and water supply. It is designed to provide air, water, vacuum and electricity to operate various dental handpieces, accessories and attachments and to serve as a base for other dental devices and accessories.
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    K Number
    K974488
    Device Name
    AIRPREP SYSTEM - MODEL 9001
    Manufacturer
    ASI MEDICAL, INC.
    Date Cleared
    1998-05-26

    (181 days)

    Product Code
    KOJ
    Regulation Number
    872.6080
    Why did this record match?
    Applicant Name (Manufacturer) :

    ASI MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Micadent is used to perform intra-oral air abrasion procedures including etching and preparing surfaces for composite restorations.
    Device Description
    The AirPrep System incorporates the Micadent air abrasion system mounted inside the unit housing along with a membrane air dryer. The Micadent handpiece is mounted in a holder along the outside of the housing.
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    K Number
    K974487
    Device Name
    SEAC ADVANCED DENTAL SYSTEM - MODEL 2001,2010 OR MODEL 2020
    Manufacturer
    ASI MEDICAL, INC.
    Date Cleared
    1998-02-18

    (84 days)

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

    ASI MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SEAC Advanced Dents System is a self-contained dental delivery system with a built-in air compressor, vacuum system and water supply. It is designed operate dental handpiece attachments and suction instruments. The SEAC Advanced Dental System can also be upgraded to include a Micadent air abrasion system mounted inside the unit with the handpiece mounted in a holder along side the other handvises connections. The Micadent is used to perform intra-oral air abrasion procedures including etching and preparing surfaces for composite restoration,
    Device Description
    The SEAC Advanced Dents System is a self-contained dental delivery system with a built-in air compressor, vacuum system and water supply. It is designed operate dental handpiece attachments and suction instruments. The SEAC Advanced Dental System can also be upgraded to include a Micadent air abrasion system mounted inside the unit with the handpiece mounted in a holder along side the other handvises connections. The Micadent is used to perform intra-oral air abrasion procedures including etching and preparing surfaces for composite restoration,
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