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510(k) Data Aggregation

    K Number
    K031664
    Device Name
    ELEMENTS OBTURATION UNIT
    Manufacturer
    SYBRON ENDO/ANALYTIC
    Date Cleared
    2004-04-28

    (335 days)

    Product Code
    EKR
    Regulation Number
    872.4565
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYBRON ENDO/ANALYTIC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Elements Obturation Unit is intended to be used in Dentistry to: 1. Provide continuous heat at the tip of a dental instrument to test tooth response to thermal stimulus, 2. For tissue cauterization and coagulation, and 3. To backfill and downpack gutta percha during Endodontic root canal treatment. 4. When in Extruder mode, the Elements Obturation Unit is used only to backfill gutta percha during root canal obturation.
    Device Description
    The device is an AC powered endodontic unit designed to be used in either of two modes, a) the System B Mode to 1) downpack and backfill gutta percha during root canal obturation, 2) test tooth response to thermal stimulus (Hot Pulp Test) and 3) for tissue cautery, and b) the Extruder Mode to backfill gutta percha during root canal obturation. The unit has an LCD screen with membrane switch controls. When using the unit in the System B Mode, the user may select the appropriate switch to downpack, backfill, cauterize or hot pulp test. While the temperature has a preset value with each of the four selections, it can also be adjusted using the temperature adjust button. In the Extruder Mode, the user may select the gutta percha type (alpha or beta), speed of extrusion (high or low), alarm sound setting and volume/mode, The endodontic obturation unit is controlled by a microprocessor that is designed to support a network style communication allowing information to be shared between endodontic devices. The System B and Extrusion hand pieces are completely removable and autoclavable.
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    K Number
    K021253
    Device Name
    ULTRASONIC TIPS WITH DIAMOND COATING
    Manufacturer
    SYBRON ENDO/ANALYTIC
    Date Cleared
    2002-07-05

    (77 days)

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

    SYBRON ENDO/ANALYTIC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Ultrasonic Tips with Diamond Coating are utilized in endodontic root preparation procedures which includes retro-prep of root ends in order to make space for permanent filling material in the canal.
    Device Description
    The Ultrasonic Tips with Diamond Coating are utilized in endodontic root preparation procedures which includes retro-prep of root ends in order to make space for permanent filling material in the canal. The tips are composed of stainless steel with a layer of fine diamond particles.
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    K Number
    K021298
    Device Name
    ELEMENTS DIAGNOSTIC UNIT
    Manufacturer
    SYBRON ENDO/ANALYTIC
    Date Cleared
    2002-06-19

    (56 days)

    Product Code
    EAT
    Regulation Number
    872.1720
    Why did this record match?
    Applicant Name (Manufacturer) :

    SYBRON ENDO/ANALYTIC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Elements Diagnostic Unit is intended to be used in dentistry to test the vitality of a tooth and to locate the apical foramen of a root canal in conjunction with endodontic root canal treatment.
    Device Description
    The device is a battery-operated, endodontic diagnostic unit designed to be used in either of two modes, V as a pulp tester to test the vitality of a tooth (by passing a pulsed, low-current, varying-voltage signal through the tooth), or A as an apex locate the apical foramen of a root canal (by measuring the impedance within a root canal) during root canal treatment. The unit uses a rechargeable battery pack, and can be used while the pack is charging. A remote satellite display that mirrors the values on the unit's graphic display can be attached to a chair, patient's bib or microscope for a more ergonomic monitoring of diagnostic status. To improve visibility and decrease eyestrain, the main body of the unit can be rotated from a vertical orientation to a 30° angle. The automatic power-off feature saves battery life and assures that the device is not left on inadvertently. The endodontic diagnostic unit is controlled by a microprocessor that is designed to support a network style communication allowing information to be shared between endodontic devices. The remote satellite display and cord assembly are completely removable. The probes, lip clips and file clips used with the device are autoclavable.
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