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510(k) Data Aggregation

    K Number
    K022803
    Device Name
    WATERLASE FOR APICOECTOMY
    Manufacturer
    BIOLASE TECHNOLOGY, INC.
    Date Cleared
    2003-02-03

    (164 days)

    Product Code
    MXF
    Regulation Number
    872.4120
    Why did this record match?
    Product Code :

    MXF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K013908
    Device Name
    WATERLASE MILLENNIUM
    Manufacturer
    BIOLASE TECHNOLOGY, INC.
    Date Cleared
    2002-02-12

    (78 days)

    Product Code
    MXF
    Regulation Number
    872.4120
    Why did this record match?
    Product Code :

    MXF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Class I, II, III, IV and V cavity preparation. Caries removal. Hard tissue surface roughening or etching. Enameloplasty, excavation of pits and fissures for placement of sealants. Cutting, shaving, contouring and resection of oral osseous tissues (bone).
    Device Description
    The Waterlase™ Millennium® hydrokinetic tissue cutting system is a diverse instrument for performing several dental applications. Waterlase™ Millennium® utilizes advanced laser and water atomization technologies to incise, excise and ablate intraoral soft and hard tissues safely and effectively. An erbium, chromium, yttrium, scandium, gallium garnet (Er, Cr.YSGG) solid state laser provides optical energy to a user controlled distribution of atomized water droplets. As the water droplets absorb the optical energy hydrokinetic cutting effects result. The hydrokinetic process refers to the removal of tissues with laser energized water particles. Strong absorption of laser energy by atomized water droplets results in an intense yet controlled water particle micro-expansion and acceleration. The resulting hydrokinetic forces induce mechanical separation of surface material, yielding quick and clean mechanical tissue removal. A flexible fiberoptic handpiece delivers the Waterlase™ Millennium's® unique hydrokinetic tissue cutting technology. A visible light emitted from the handpiece distal end pinpoints the area of treatment. The optical power output and atomized water spray distribution may be adjusted to specific user requirements.
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    K Number
    K012511
    Device Name
    WATERLASE MILLENNIUM
    Manufacturer
    BIOLASE TECHNOLOGY, INC.
    Date Cleared
    2002-01-18

    (165 days)

    Product Code
    MXF
    Regulation Number
    872.4120
    Why did this record match?
    Product Code :

    MXF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tooth preparation to obtain access to the root canal Pulpotomy Pulp extirpation Pulpotomy as an adjunct to root canal therapy Root canal debridement and cleaning Root canal preparation including enlargement
    Device Description
    The Waterlase Millennium dental laser system may be used to perform several dental applications. For hard tissue procedures the Waterlase Millennium utilizes the Erbium, Chromium: Yttrium, Scandium, Gallium, Garnet (Er,Cr:YSGG) laser in combination with advanced water atomization technology to cut, remove, roughen and etch tissues. Soft tissue procedures are performed using a different mode of operation where direct Er,Cr.YSGG laser energy is applied to incise, excise or ablate the tissues. In soft tissue procedures the water spray is applied for hydration, cooling or to keep tissues clean. A flexible fiberoptic handpiece delivers the Waterlase Millennium laser energy. A visible light emitted from the handpiece distal end pinpoints the area of treatment. In both hard and soft tissue applications the power output, pulse energy, repetition rate and air and water flow rates are adjustable to specific user requirements.
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    K Number
    K990908
    Device Name
    MILLENNIUM
    Manufacturer
    ENDO TECHNIC CORP.
    Date Cleared
    1999-05-27

    (70 days)

    Product Code
    MXF
    Regulation Number
    872.4120
    Why did this record match?
    Product Code :

    MXF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use on adult and pediatric patients for the following: Class I, II, III, IV and V cavity preparation Caries removal Hard tissue surface roughening or etching Enameloplasty, excavation of pits and fissures for placement of sealants
    Device Description
    The Millennium™ hydrokinetic tissue cutting system is a diverse instrument for performing several dental applications. Millennium™ utilizes advanced laser and water atomization technologies to incise, excise and ablate intraoral soft and hard tissues safely and effectively. An erbium, chromium, yttrium, scandium, gallium garnet (Er, Cr:YSGG) solid state laser provides optical energy to a user controlled distribution of atomized water droplets. As the water droplets absorb the optical energy hydrokinetic cutting effects result. The hydrokinetic process refers to the removal of tissues with high speed, atomized water particles. Strong absorption of laser energy by atomized water droplets results in an intense yet controlled water particle micro-expansion and acceleration. The resulting hydrokinetic forces induce mechanical separation of surface material, vielding quick and clean mechanical tissue removal. A flexible fiberoptic handpiece delivers the Millennium™s unique hydrokinetic tissue cutting technology. A visible light emitted from the handpiece distal end pinpoints the area of treatment. The optical power output and atomized water spray distribution may be adjusted to specific user requirements.
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    K Number
    K990219
    Device Name
    MODIFICATION OF MILLENNIUM
    Manufacturer
    BIOLASE TECHNOLOGY, INC.
    Date Cleared
    1999-02-24

    (33 days)

    Product Code
    MXF
    Regulation Number
    872.4120
    Why did this record match?
    Product Code :

    MXF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Class I - V cavity preparation Caries removal Hard tissue surface roughening or etching
    Device Description
    The Millennium™ hydrokinetic tissuc cutting system is a diverse instrument for Pine Millennium - Hydrokins. Millennium™ utilizes advanced laser and performing coverer. comologies to incise, excise and ablate intraoral soft and hard water alonitation totatively. An erbium, chromium, yttrium, scandium, gallium gamet (Er, Cr.YSGG) solid state laser provides optical energy to a user controlled distribution of atomized water droplets. As the water droplets absorb the optical energy hydrokinetic cutting effects result. The hydrokinetic process refers to the removal of tissues with high speed, atomized water particles. Strong absorption of laser energy by atomized water droplets results in an intense yet controlled water particle micro-expansion and acceleration. The resulting hydrokinetic forces induce mechanical separation of surface material, yielding quick and clean mechanical tissue removal. A flexible fiberoptic handpiece delivers the Millennium™s unique hydrokinetic tissue cutting technology. A visible light emitted from the handpiece distal end pinpoints the area of treatment. The optical power output and atomized water spray distribution may be adjusted to specific user requirements.
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