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510(k) Data Aggregation

    K Number
    K112305
    Device Name
    VIGOR A LOW SPEED AIR MOTOR, VIGOR C LOW SPEED CONTRA-ANGLE HANDPIECES, VIGOR S LOW SPEED STRAIGHT HANDPIECES
    Manufacturer
    THUNDER TIGER CORP.
    Date Cleared
    2012-04-17

    (250 days)

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

    THUNDER TIGER CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Vigor Series Low speed dental handpieces & Accessories are powered by either low speed air motor or electric micro-motor for teeth cutting, cavity and crown preparation, restorations and polishing teeth. The Vigor A Low Speed Air Motor is used in conjunction with accessories such as contra-angle, such as The Vigor C Low Speed Contra-Angle handpieces, and straight handpiece, such as The Vigor S Low Speed Straight handpieces. The motor contains chip air and water that help with removing debris from teeth cutting. The Low Speed Contra Angle Dental Handpiece that is intended for removing carious material, cavity and crown preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth. The Straight Handpiece contains chip air and water that help with removing debris from teeth cutting.
    Device Description
    The Vigor Series Low speed dental handpieces & Accessories are similar to other low-speed dental handpieces currently on the US dental market in design, function, and intended use. The devices are powered by either low speed air motor or electric micro-motor that are reusable and ergonomically shaped, and are provided without a fiber optic light system. The Vigor C Low Speed Contra-Angle handpieces are used in conjunction with low speed motors manufactured in accordance with ISO7785-2 and ISO13294 respectively. The bottom design of these contra angle handpieces allows easy "snap-on" connection and removal from the motor. The contra-angle handpieces contain both chip air and water that help with removing debris from teeth cutting. The Vigor S Low Speed Straight handpieces are used in conjunction with low speed motors manufactured in accordance with ISO7785-2 and ISO13294 respectively. The bottom design of the Low Speed Straight handpiece allows easy connection and removal from the motor. It can be used with a variety of different burrs that conform to the specifications stated in ISO 1797-1. These nose-cones contain both chip air and water that help with removing debris from teeth cutting. The Vigor A Low Speed Air Motor is used in conjunction with accessories such as contra-angle and straight handpiece that are manufactured in accordance with ISO 7785-2. The locking mechanism of the motor allows easy connection and removal of any add-ons. The motor contains chip air and water that help with removing debris from teeth cutting. The devices are reused and can be sterilized by the steam autoclave method.
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    K Number
    K102517
    Device Name
    TIGER 500 SERIES HIGH SPEED HANDPIECES AND ATTACHMENTS
    Manufacturer
    THUNDER TIGER CORP.
    Date Cleared
    2011-04-27

    (237 days)

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

    THUNDER TIGER CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tiger 500 Series High Speed Handpieces and Attachments are intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
    Device Description
    The Tiger 500 series High Speed Handpieces and Attachments are similar to other high-speed dental handpieces currently on the US dental market in design, function, and intended use. The devices are air-powered handpieces that are reusable and ergonomically shaped, and are provided both with and without a fiber optic light system. The devices are supplied non-sterile, but must be sterilized before use, as with the predicate device. It will be packaged as a single-use bag. Several models could be connected to couplings of manufacturers including TTBIO, KaVo, NSK Mach, Sirona, and Star. According to IS07785-1:1997, Dental Handpiece-- Part 1: High-speed air turbine handpieces; and IS013485:2003, Medical Device Quality Management System to complete the device design steps.
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    K Number
    K062812
    Device Name
    DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 300T, 300K, 300W, 300B AND 300N
    Manufacturer
    THUNDER TIGER CORP.
    Date Cleared
    2006-11-28

    (70 days)

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

    THUNDER TIGER CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The THUNDER TIGER Dental Air-Powered Handpiece is intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth.
    Device Description
    Dental Air-Powered Handpiece, models TIGER 300T, TIGER 300K, TIGER 300W, TIGER 300B, TIGER 300N
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    K Number
    K052822
    Device Name
    DENTAL AIR-POWERED HANDPIECE, MODELS TIGER 100, 101, 200, 201 AND 202
    Manufacturer
    THUNDER TIGER CORP.
    Date Cleared
    2006-01-20

    (108 days)

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

    THUNDER TIGER CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    THUNDER TIGER Dental Air-Powered Handpiece, models TIGER 100, TIGER 101, TIGER 200, TIGER 201, TIGER 202 are intended for removing carious material, reducing hard tooth structure, cavity preparation, finishing tooth preparations and restorations and polishing teeth. CAUTION: Federal (US) law restricts the use of this device to licensed professionals.
    Device Description
    Dental Air-Powered Handpiece, models TIGER 100, TIGER 101, TIGER 200, TIGER 201, TIGER 202
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