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510(k) Data Aggregation

    K Number
    K974670
    Device Name
    ATHENA 1:1 CONTRA ANGLE, ATHENA 4:1 CONTRA ANGLE, ATHENA 16:1 CONTRA ANGLE, ATHENA 64:1 CONTRA ANGLE, ATHENA 16-: CONTRE
    Manufacturer
    ATHENA TECHNOLOGY, INC.
    Date Cleared
    1998-03-13

    (88 days)

    Product Code
    EFB
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATHENA TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Attachments are used in conjunction with a 20R "E" type slow speed handpiece motor to prepare carious teeth for restorations; to perform prophylaxis or other general procedures performed by the dentist in the oral cavity or in a laboratory environment.
    Device Description
    Athena nosecones include models to fit "E" type slow speed motors, Midwest and Star slow speed handpiece in two versions, the standard 1:1 non-reduction model and the 4:1 speed reduction model. These have four ball bearing construction; durable stainless steel chuck and operating mechanism. Uses standard handpiece burs, disposable and metal prophy angles. Athena contra angles include models to fit "E" type slow speed motors and Midwest slow speed handpieces. "E" type models include a standard 1:1 non-reduction model and three speed reduction models 4:1, 16:1 and 64:1. The Midwest version is a 16:1 speed reduction. They convert a straight handpiece to an angle for increased access in the oral cavity. The reduction angles use stainless steel gears and four ball bearings for durability and longevity. Uses latch type heads.
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    K Number
    K974671
    Device Name
    ATHENA 20R S TYPE SLOW SPEED HANDPIECE MOTOR
    Manufacturer
    ATHENA TECHNOLOGY, INC.
    Date Cleared
    1998-03-11

    (86 days)

    Product Code
    EFB
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    ATHENA TECHNOLOGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Use in combination with attachments, i.e., a nosecone or contra angle to prepare carious teeth for restorations; to perform prophylaxis; endodontic preparations or other procedures used by a dentist in the oral cavity.
    Device Description
    20R "E" type slow speed dental handpiece motor; fully autoclavable (up to 135°C); utilizes an E type coupling to accept standard E type attachments. ISO couplings B, C and D are available.
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