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510(k) Data Aggregation

    K Number
    K150129
    Device Name
    AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION)
    Manufacturer
    Aseptico, Inc.
    Date Cleared
    2015-05-28

    (127 days)

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

    Aseptico, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AEU-700L-70V is a drive system for instruments and tools used in dentistry for implants / surgical and endodontic procedures. The system includes an irrigation supply and a wide range of user controls designed to provide drilling during osteotomy preparation and implant placement, or endodontic therapy.
    Device Description
    Not Found
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    K Number
    K142124
    Device Name
    AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM
    Manufacturer
    ASEPTICO, INC.
    Date Cleared
    2014-12-31

    (149 days)

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

    ASEPTICO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AEU-6000-70V and AEU-6000 are drive systems for instruments and tools used in dentistry for implants/surgical procedures and endodontic procedures. The systems include an irrigation supply and a wide range of user controls designed to provide drilling during osteotomy preparation and implant placement or endodontic therapy.
    Device Description
    drive systems for instruments and tools used in dentistry for implants/surgical procedures and endodontic procedures. The systems include an irrigation supply and a wide range of user controls designed to provide drilling during osteotomy preparation and implant placement or endodontic therapy.
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    K Number
    K130693
    Device Name
    AEU-525 TRANSPORT III PORTABLE DENTAL SYSTEM
    Manufacturer
    ASEPTICO, INC.
    Date Cleared
    2013-08-14

    (153 days)

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

    ASEPTICO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    To be used for endodontic and general dentistry applications.
    Device Description
    Not Found
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    K Number
    K111078
    Device Name
    AEU-26L ELCTRONIC ENDODONTIC SYSTEM
    Manufacturer
    ASEPTICO, INC.
    Date Cleared
    2011-06-14

    (57 days)

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

    ASEPTICO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in a wide range of dental procedures including; endodontic surgeries, such as drilling in to the tooth canal, and general dentistry, such as removing carious material from the dentin.
    Device Description
    Model Number: AEU-26L Classification Name: 872.4200 Dental handpiece and accessories Product Code: EKX handpiece, direct drive, ac-powered Primary accessories exclusive to the AEU-26L system: - a) AEU-26L Consol (Controller) - b) AE-250L-30 Low Voltage Electric Motor - c) On/Off Foot Pedal - d) Motor holder attaching bracket The AEU-26L is software controlled and has the following features: - a) Allows adjustment of the motor speed from 300 to 30,000 RPM - b) Allows setting the torque applied to the motor in gram/cm - c) Allows selection of gear ratios for different geared E-Type handpieces - d) Allows selection of forward or reverse drive rotation - e) Allows reciprocating drive (forward/reverse cycling) - Allows use of a foot pedal control to operate the attached handpiece motor - Allows the user to define their own presets for speed (RPM) and torque (gram g) - h) Allows for attaching geared handpieces that include optics for a light.
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    K Number
    K101332
    Device Name
    AMC-20 PORTABLE DENTAL CART MODEL AMC-20
    Manufacturer
    ASEPTICO, INC.
    Date Cleared
    2011-04-11

    (334 days)

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

    ASEPTICO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AMC-20 is a self-contained mobile dental cart that is used for general dentistry and endodontic applications.
    Device Description
    AMC-20 Mobile Dental Cart
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    K Number
    K103399
    Device Name
    GENERAL DENISTRY MOTOR
    Manufacturer
    ASEPTICO, INC.
    Date Cleared
    2011-02-28

    (101 days)

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

    ASEPTICO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Can be used for a wide range of dental procedures including endodontic surgeries, such as drilling into the root canal, and general dentistry, such as removing carious material from the dentin.
    Device Description
    Not Found
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    K Number
    K070866
    Device Name
    ASC-12 PIEZOELECTRIC SCALER
    Manufacturer
    ASEPTICO, INC.
    Date Cleared
    2007-04-11

    (13 days)

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

    ASEPTICO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ASC-12 is an ultrasonic scaler that is intended for the following procedures: Scaling: Interdentium treatment Tooth neck and subgingival treatment Treatment of large dental calculi Treatment of coatings and tobacco stains Treatment of periodontal pockets Interproximal treatment Loosening of crowns and posts Endodontics: Pulp Chamber Cleaning Canal filling by ultrasonic gutta-percha condensation
    Device Description
    The ASC-12 is an AC mains-powered piezoelectric ultrasonic scaler intended for scaling and endodontic procedures. The device consists of a console, a footswitch and an autoclavable handpiece with interchangeable and autoclavable scaling tips.
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    K Number
    K051077
    Device Name
    E-TYPE STRAIGHT HANDPIECE, MODEL AHP-101
    Manufacturer
    ASEPTICO, INC.
    Date Cleared
    2005-05-03

    (6 days)

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

    ASEPTICO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AHP-101 fully autoclavable, straight, 1:1 ratio E-Type dental handpiece is intended for use in general dentistry procedures, such as removing carious material from the dentine.
    Device Description
    The AHP-101 is a straight, fully autoclavable, 1:1 ratio E-Type dental handpiece intended for use in general dentistry procedures. It accepts standard 2.35mm (3/32") burs and may be used with prophy angles.
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    K Number
    K050201
    Device Name
    AEU-14CF EXPENDITION
    Manufacturer
    ASEPTICO, INC.
    Date Cleared
    2005-03-18

    (49 days)

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

    ASEPTICO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EXPEDITION offers the dental professional the capability of carrying a complete dental operative system in one transportable case. The system is suitable for performing general dental procedures anywhere there is a suitable surface to contain and be operated on internal power source. Additionally, the internal power source can be recharged using a detachable solar panel.
    Device Description
    The AEU-14CF Expedition is a portable electric dental system intended to provide basic dentistry capabilities in emergency and field situations. The Expedition features an "E" type autoclavable 30,000 RPM brushless micro motor with interchangeable headpieces, a 3-way air/water syringe, a self-contained water system, and an oil-less air compressor. The Expedition is powered by internal 27.6V battery packs, and may be connected to a 120V/230V AC power source or to a 12/24V vehicle battery for extended operation or recharging. A detachable solar panel is also provided for recharging the internal batteries when other sources are not available.
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    K Number
    K030895
    Device Name
    ASEPTICO ENDOPEX V, MODEL AEU-40
    Manufacturer
    ASEPTICO, INC.
    Date Cleared
    2003-12-03

    (257 days)

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

    ASEPTICO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Endopex V is used to estimate the position an endodontic file in the root canal. The devices enhances endodontic surgery by enabling the dentist to reduce the number of required radiographs.
    Device Description
    Using two electrodes, electrical impedance is measured between a root canal file positioned inside the tooth and another making contact with the oral cavity along the lip. The software inside the Endopex V compares the impedance values being read between its two electrodes with impedance values stored in its software database. The comparison of impedance values are than converted to readings on the LED to indicate the estimated position of the endodontic file in relation to the inside root canal and the Apical Foramen.
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