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510(k) Data Aggregation

    K Number
    K061966
    Device Name
    LITETOUCH DENTAL LASER SYSTEM
    Date Cleared
    2006-09-27

    (77 days)

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

    LIGHT INSTRUMENT LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LITETOUCH dental laser system is intended to aid during dental procedures performed in oral and maxillofacial surgery and dentistry. The Erbium: Y AG laser is indicated for a variety of hard tissue (tooth and bone) applications, and for the incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery and dentistry. This includes the following: Hard Tissue Indications of Erbium Laser Energy: - Caries removal - Cavity preparation - Enamel etching - Enameloplasty, excavation of pits and fissures for placement of sealant Bone Indications of Erbium Laser Energy: - Contact and non-contact cutting, shaving, contouring, and resection of oral osseous tissue (bone) - Apicoectomy - amputation of the root end - Cutting bone to prepare a window access to the apex (apices) of the root(s) - Osseoplasty - Osteotomy - Osseous crown lengthening Soft Tissue and Periodontal Indications of Erbium Laser Energy: - Excisional and incisional biopsies - Exposure of unerupted teeth - Incision and drainage of abscesses - Gingival incision and excision - Gingivoplasties - Gingivectomies, Gingivectomy in case of hyperplasias of the gingival or excision of hyperplasias - Gingival troughing for crown impressions - Hemostasis - Implant recovery - Frenectomies and frenotomies - Fibromatosis (fibroma removal) - Benign and malignant lesion removal - Operculectomy - Oral papillectomies - Reduction of gingival hypertrophy - Soft tissue crown lengthening - Preprosthetic surgery: flabby alveolar ridge, vestibuloplasty, exposure of implants, hyperplasia, epulides, papillomas, fibromatoses benign growths - Vestibuloplasty - 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) Endodontal Indications of Erbium Laser Energy: - Tooth preparation to obtain access to root canal - Pulpotomy, Pulpotomy as an adjunct to root canal therapy - Pulp extirpation - Root canal debridement and cleaning - Root canal preparation including enlargement
    Device Description
    The LITETOUCH is an advanced microprocessor-controlled laser system, composed of the following units: - Control panel - Laser accessory, including the Erbium laser assembly and water spray equipment - High-voltage power supply, capacitor bank and switching module - Cooling unit - Tip power detection module
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