LogoFDA 510(k) Search
Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K984508
    Device Name
    SURGICAL CONTRA-ANGLE HANDPIECES, MODELS 975 AE,979 E/KM, 985 AE, 986 AE, 988 E/KM AND SURGICAL STRAIGHT HANDPIECES MOD
    Manufacturer
    W & H DENTALWERK BUERMOOS GMBH
    Date Cleared
    1999-06-25

    (189 days)

    Product Code
    DZA
    Regulation Number
    872.4130
    Why did this record match?
    Product Code :

    DZA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indications are very widespread in the field of oral surgery ranging from - A. Implant placement, including - 1. preparation of the osteotomy site - 2. bone recontouring, osteoplasty - B. Bone grafting - 1. Preparation of the donor site (for e.g. symphysis and ascending rames etc.) - 2. harvesting autogen living bone - 3. sinus elevation & grafting of alveolar sockets - C. Removal and sectioning of teeth and teeth bone for e.g. impacted third molars and complicated extractions - D. Periodontal surgeries - 1. bone recontouring & alveoplasty around living teeth - 2. removal of exostosis - E. Endodontic treatment Intracanal preparations using rotating NiTi-files.
    Device Description
    Surgical Contra-Angle Handpieces Types 975 AE. 979 E/KM. 985 AE. 986 AE, 988 E/KM Surgical Straight Handpieces Types S 11, SL 11
    Ask a Question
    K Number
    K962979
    Device Name
    S-53 INTRORAL DENTAL SYSTEM
    Manufacturer
    DEL MEDICAL SYSTEMS CORP.
    Date Cleared
    1996-09-25

    (56 days)

    Product Code
    DZA
    Regulation Number
    872.4130
    Why did this record match?
    Product Code :

    DZA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    the intended use the same
    Device Description
    The design of the S-53 is virtually identical to the comparative devices which are listed and displayed in Exhibits 2 and 3.
    Ask a Question
    K Number
    K954790
    Device Name
    PROFILE NICKEL TITANIUM ROTARY INSTRUMENTS
    Manufacturer
    TULSA DENTAL PRODUCTS, LTD.
    Date Cleared
    1996-01-16

    (89 days)

    Product Code
    DZA
    Regulation Number
    872.4130
    Why did this record match?
    Product Code :

    DZA

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

    Page 1 of 1