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    K Number
    K023547
    Device Name
    DIOLASE 980 D LASER SYSTEM
    Manufacturer
    AMERICAN DENTAL TECHNOLOGIES, INC.
    Date Cleared
    2003-04-15

    (176 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN DENTAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diolase 980 D Diode Dental Laser System is intended for use in the following procedures: Frenectomy, Frenotomy, Biopsy, Operculectomy, Implant Recovery, Gingivectomy, Gingivoplasty, Gingival Troughing, Crown Lengthening, Hemostasis of Donor Site, Removal of Granulation Tissue, Laser-assisted Flap Surgery, Debridement of Deseased Epithelial Lining, Incisions and Draining of Abscesses, Tissue Retraction for Impressions, Papillectomy, Vestibuloplasty, Excision of Lesions, Leukoplakia, Exposure of Unerupted/Partially Erupted Teeth, Removal of Hyperplastic Tissues, Treatment of Aphthous Ulcers, Sulcular Debridement, Pulpotomy, Pulpotomy as an Adjunct to Root Canal Therapy, and Light Activation of Bleaching Materials.
    Device Description
    The Diolase 980 D Diode Dental Laser System is a portable instrument intended for ablating, incising, excising, and coagulating intraoral soft tissue (including the marginal and interdental gingival) using a contact fiber optic delivery system.
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    K Number
    K012127
    Device Name
    PULSEMASTER ERBIUM DENTAL LASER SYSTEM
    Manufacturer
    AMERICAN DENTAL TECHNOLOGIES, INC.
    Date Cleared
    2001-10-04

    (87 days)

    Product Code
    GEX, MXF
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN DENTAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PulseMaster Erbium Dental laser System is intended for the removal of caries and cavity preparation for primary and secondary teeth, the modification and etching of enamel and dentin prior to acid etching, and the incision, excision, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery including, but not limited to, gingival tissues.
    Device Description
    The PulseMaster Erbium Dental Laser System is a solid state Er.YAG laser consisting of three internally connected subassemblies: the power supply, the water cooling system, and the Er. YAG pump cavity and resonator assembly. Delivery is via a fiber optic with a sapphire contact tip. The laser delivers up to 400 mJ per pulse, with pulse repetition rates ranging from 10 to 60 Hz and an average power of up to 7.5 Watts.
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    K Number
    K012213
    Device Name
    GULLIVER AND CLASSE A
    Manufacturer
    AMERICAN DENTAL TECHNOLOGIES, INC.
    Date Cleared
    2001-08-13

    (28 days)

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

    AMERICAN DENTAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The American Dental Technologies Dental Operative Units are intended to supply power to and serve as a base for dental devices and accessories.
    Device Description
    The American Dental Technologies Dental Operative Units are standard electrical or pneumatically operated dental operative units that will be available in two product lines, the Gulliver and the Classe A, and several models. Both the Gulliver and Classe A Dental Operative Units consist of the following major components: - Patient Treatment Chair . - The Dentist's Instrument Board . - Assistants Board . - Cuspidor/Water system . - Overhead Dental Light .
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    K Number
    K984486
    Device Name
    PULSEMASTER DENTAL LASER SYSTEM
    Manufacturer
    AMERICAN DENTAL TECHNOLOGIES, INC.
    Date Cleared
    1999-05-13

    (147 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN DENTAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The American Dental Technologies, Inc. PulseMaster Dental Laser Systems are indicated for use for selective ablation of enamel (first degree) dental caries.
    Device Description
    The American Dental Technologies PulseMaster Dental Laser Systems are Nd:YAG lasers producing laser emission at 1064 nm. The lasers consist of two interconnected sections: The cabinet which houses the laser head, the power supply, the cooling system and the microprocessor with control panel; and the fiber optic delivery system.
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    K Number
    K972325
    Device Name
    PULSEMASTER 1000 ST DENTAL LASER SYSTEM
    Manufacturer
    AMERICAN DENTAL TECHNOLOGIES, INC.
    Date Cleared
    1997-09-19

    (88 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN DENTAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PulseMaster® 1000 ST Dental Laser System is a portable instrument intended for ablating, incising, excising, and coagulating intraoral soft tissue (including the marginal and interdental gingiva) using a contact fiber optic delivery system. The device is indicated for use in the following procedures: - lesion (tumor) removal - biopsies - fibroma removal - frenectomies and frenotomies - gingivoplasties - gingivectomies - leukoplakia - operculectomies - oral papillectomies - aphthous ulcers - sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss, and tooth mobility.
    Device Description
    The PulseMaster® 1000 ST Dental Laser System is a portable diode laser system intended for ablating, incising, excising, and coagulating intraoral soft tissue (including the marginal and interdental gingiva) using a contact fiber optic delivery system. The device is software-controlled and utilizes high brightness diode laser technology to provide similar performance characteristics to Nd:YAG lasers.
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    K Number
    K961269
    Device Name
    PULSEMASTER
    Manufacturer
    AMERICAN DENTAL TECHNOLOGIES, INC.
    Date Cleared
    1997-03-10

    (342 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN DENTAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Sulcular Debridement
    Device Description
    Dental Laser System
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    K Number
    K961136
    Device Name
    PULSEMASTER
    Manufacturer
    AMERICAN DENTAL TECHNOLOGIES, INC.
    Date Cleared
    1996-06-03

    (74 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    AMERICAN DENTAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    treatment of aphthous ulcers
    Device Description
    Dental Laser System
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