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510(k) Data Aggregation

    K Number
    K022097
    Device Name
    THERMIQUE
    Manufacturer
    PARKELL, INC.
    Date Cleared
    2002-09-06

    (71 days)

    Product Code
    EAT
    Regulation Number
    872.1720
    Why did this record match?
    Product Code :

    EAT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use during condensation of gutta percha in tooth root canals. May also be used as a pulp r of use during ochaoned. Of Samal stimulus through molten gutta percha.
    Device Description
    Thermique Thermal Condenser
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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?
    Product Code :

    EAT

    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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    K Number
    K012427
    Device Name
    PHARMAETHYL LOCAL PULP AND VITALITY TESTING AGENT
    Manufacturer
    SPECIALITES SEPTODONT
    Date Cleared
    2001-10-09

    (70 days)

    Product Code
    EAT
    Regulation Number
    872.1720
    Why did this record match?
    Product Code :

    EAT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pharmaéthyl® Local pulp and vitality testing agent is indicated as topical pulp and tooth vitality testing agent.
    Device Description
    Not Found
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    K Number
    K011666
    Device Name
    CHILLIT
    Manufacturer
    HEATSHIELD, INC.
    Date Cleared
    2001-08-06

    (68 days)

    Product Code
    EAT, DYJ, EKZ, MLY
    Regulation Number
    872.1720
    Why did this record match?
    Product Code :

    EAT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. COOLING HEAT SENSITIVE ORTHODONTIC WIRES 2. TOPICAL ANESTHETIC 3. PULP TEST THE VITALITY OF TEETH
    Device Description
    Not Found
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    K Number
    K990225
    Device Name
    ENDO ANALYZER, MODEL 8005, MODIFIED
    Manufacturer
    SYBRON DENTAL SPECIALTIES, INC.
    Date Cleared
    1999-02-25

    (31 days)

    Product Code
    EAT
    Regulation Number
    872.1720
    Why did this record match?
    Product Code :

    EAT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the endodontic analyzer is to test the vitality of a tooth and to locate the apical foramen of a root canal in conjunction with endodontic root canal treatment. The Endo Analyzer, Model 8005, Modified 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 analyzer which is designed to test the vitality of a tooth (by passing a pulsed, low-current, varying-voltage signal through the tooth) and to locate the apical foramen of a root canal (by measuring the impedance within a root canal) during root canal treatment. The unit is battery operated using six (6) 1.5 volt size AA alkaline batteries. An automatic power-off feature saves battery life and assures that the device is not left on inadvertently. The unit may be used in either of two modes, V.S. as a pulp tester or A.F. as an apex locator. The endodontic analyzer is controlled by a microprocessor and the handpiece and cord assembly are completely removable. The probes, lip clips and file clips used with the device are autoclavable.
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    K Number
    K973439
    Device Name
    ENDO ANALYZER, MODEL 8005
    Manufacturer
    SYBRON DENTAL SPECIALTIES, INC.
    Date Cleared
    1997-12-08

    (89 days)

    Product Code
    EAT
    Regulation Number
    872.1720
    Why did this record match?
    Product Code :

    EAT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Endo Analyzer, Model 8005, 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 analyzer which is designed to test the vitality of a tooth and to locate the apical foramen of a root canal during root canal treatment. The unit is battery operated using three (3) 1.5 volt size AA alkaline batteries. An automatic power-off feature saves battery life and assures that the device is not left on inadvertently. The unit may be used in either of two modes, V.S. as a vitality scanner or A.F. as an apex locator. The endodontic analyzer is controlled by a microprocessor and the handpiece and cord assembly are completely removable. The handpiece and cord assembly, including the vitality scanner tips and lip clip used with the device, are autoclavable.
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    K Number
    K970715
    Device Name
    SYSTEM B HEAT SOURCE
    Manufacturer
    SYBRON DENTAL SPECIALTIES, INC.
    Date Cleared
    1997-04-07

    (39 days)

    Product Code
    EAT
    Regulation Number
    872.1720
    Why did this record match?
    Product Code :

    EAT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The System B HeatSource, Model 1005, is intended to be used in dentistry to provide continuous heat at the tip of a dental instrument to test tooth response to thermal stimulus and for tissue cauterization and coagulation.
    Device Description
    The device is a battery-operated dental instrument heater which is designed to provide continuous heat at the tip of a dental instrument, the Hot Pulp Test Tip and the Cauterizing Tip, to test tooth response to thermal stimulus and for tissue cauterization and coagulation, respectively. The battery is fully rechargeable through the use of the plug-in charge adapter. The temperature is regulated by a feedback control system which automatically maintains a preset temperature for consistent results. The handpiece and cord assembly are completely removable. Both the handpiece and cord assembly and the dental instruments used with the device are autoclavable.
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    K Number
    K963862
    Device Name
    TOUCH N' HEAT
    Manufacturer
    SYBRON DENTAL SPECIALTIES, INC.
    Date Cleared
    1996-12-02

    (69 days)

    Product Code
    EAT
    Regulation Number
    872.1720
    Why did this record match?
    Product Code :

    EAT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the device is to provide continuous heat at the tip of a dental instrument, the Hot Pulp Test Tip, to test tooth response to thermal stimulus.
    Device Description
    The device, which is battery-operated (Model 5001 and 5004) or powered by a wall adapter (Model 5002), is designed to provide continuous heat at the tip of a dental instrument, the Hot Pulp Test Tip, to test tooth response to thermal stimulus. The battery operated models are fully rechargeable through the use of the plug-in charge adapter. The Hot Pulp Test Tip is heated to the desired temperature. A medium, such as a ball of softened gutta percha, is used to transfer the heat from the Hot Pulp Test Tip to the tooth. The gutta percha ball is dipped into talcum powder or Vaseline to prevent it from sticking to the tooth. The Hot Pulp Test Tip is placed in firm contact with the tooth, ensuring that a good contact is established. The patient's response to the heat is evaluated by the clinician to determine whether the pulp is healthy or inflamed.
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    K Number
    K960799
    Device Name
    ORTHO-ICE
    Manufacturer
    ULTIMATE WIREFORMS, INC.
    Date Cleared
    1996-05-09

    (72 days)

    Product Code
    EAT
    Regulation Number
    872.1720
    Why did this record match?
    Product Code :

    EAT

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

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