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510(k) Data Aggregation

    K Number
    K243911
    Device Name
    HPR Cordless Hygiene Handpiece
    Manufacturer
    Handpiece Headquarters
    Date Cleared
    2024-12-20

    (1 days)

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

    Handpiece Headquarters

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HPR Cordless Hygiene Handpiece is a cordless prophylaxis handpiece featuring control buttons and equipped with a battery pack and a wireless foot control. It is designed for use with disposable prophylaxis angles in hygiene operatory to perform cleaning and polishing procedures on teeth surface and fillings.
    Device Description
    The HPR Cordless Hygiene Handpiece is a cordless prophylaxis handpiece featuring control buttons and equipped with a battery pack and a wireless foot control.
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    K Number
    K233518
    Device Name
    BASE290 LED Curing Light
    Manufacturer
    Handpiece Headquarters
    Date Cleared
    2023-11-02

    (1 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Why did this record match?
    Applicant Name (Manufacturer) :

    Handpiece Headquarters

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This "BASE290 LED Curing Light" is a dental curing unit utilizing visible light programmed for the polymerization of light curing materials in the wavelength range of 380-500 nm by dental professionals.
    Device Description
    Not Found
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    K Number
    K180845
    Device Name
    Maxima Electric System
    Manufacturer
    Handpiece Headquarters - HPR Inc.
    Date Cleared
    2019-07-25

    (479 days)

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

    Handpiece Headquarters - HPR Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Maxima Electric System is intended to convert pneumatic output from a dental treatment center to electrical energy to drive an electric micro motor and to operate electrically- driven dental handpieces. This system is designed for use by a trained professional in the field of general dentistry.
    Device Description
    Maxima Electric System is a system attached to dental system to operate Electricallydriven low speed handpieces. The common gear ratio is 1:1 and 1:5, the speed range is from 100 to 40,000 rpm. Software used on control box is to control speed, forward and reverse direction of the handpieces; turn on an off the cooling water and LED light. There are 3 memories for speed of common low speed handpieces can be save into the program. The air hose is connect the air and water from 4-hole standard handpiece hose from dental system to the control unit, the existing air pedal from dental system is to turn on and off and control speed by converting pneumatic from dental system to electrical energy to operate electric handpieces. The control box is power by a power supply AC/DC voltage 36 VDC. Maxima Electric System consists of the following components: 1-Control Unit 2-Motor Cable 3-Micromotor (Model ELM-B40S) 4-Accessories including the following a-Foot switch (optional) b-AC/DC Adapter c-AC cord A control unit, Motor Cable and a Micro-motor.
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    K Number
    K143183
    Device Name
    Maxima XTEND Handpiece Maintenance System
    Manufacturer
    HANDPIECE HEADQUARTERS
    Date Cleared
    2015-02-17

    (104 days)

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

    HANDPIECE HEADQUARTERS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Maxima XTEND Handpiece Maintenance System is intended for cleaning and lubrication of dental Handpieces including air turbines, air motors and air driven scalers prior to sterilization.
    Device Description
    Maxima XTEND Handpiece Maintenance System is a complete automatic dispensing system for cleaning: lubrication and purging old oil for dental handpieces prior to sterilization cvcles. User can use push button kev pad to select time for purqing lubricant into handpiece including 15 seconds, 20 seconds, and 30 seconds. In addition, there are 11 adjustable settings for the amount of lubricant into the handpiece; user can choose the amount of lubricant to purge into handpieces accordingly. The system can maintenance up to 3 handpieces at the same time, and an unique chuck care nozzle to lubricate chucks in dental turbines. Service Maxima XTEND Handpiece maintenance system is capable to operate with aerosol lubricant can with or without compressed-air supply. Air pressure will deliver Lubricant directly through internal parts of handpieces and contra angles by the controlling of software to open and close magnetic valves. The system will purge all the excess lubricant. The provided linen pads and removable trays on front side and bottom of the system will absorb the excess liquid of lubricant. Lubricant uses for the Maxima Handpiece Maintenance System is aerosol spray can "Maxima Handpiece Cleaner & Lubricant" has been previous cleared with 510(k) # K113674 The Maxima XTEND Handpiece Maintenance System contains following main components: - Main case 1 - Rear case - Front door module - 4 PCBA board - 5 Power supply - 6 Adapters module - 7 LCM Module - 8 Oil supply module - Solenoid valve - 10 Rear components module - 11 Back plate cover - 12 Top cover - 13 Veneer (Bright Blue) - 14 Oil trav - 15 Rotation motor module
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    K Number
    K141125
    Device Name
    U-TYPE CONTRA ANGLE, U-TYPE SECTIONAL CONTRA ANGLE
    Manufacturer
    HANDPIECE HEADQUARTERS
    Date Cleared
    2014-10-23

    (175 days)

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

    HANDPIECE HEADQUARTERS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The U-Type Contra Angles and U-Type Sectional Contra Angles are used to mount on U-Type Nose Attachments and powered by either low speed air motors or electric micro motors. These U-Types are intended for removing carious material, cavity and crown preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth.
    Device Description
    U-Type contra angles and U-Type sectional contra angles are used to mount on U-Type Nose Attachments and powered by either low speed air motors or low speed electric motors. These U-Type Contra Angle Attachments are gear 1:1 to the low speed air motors or low speed electrical motors. As results, they transmit the same speed and torque from the connected air motors or electric motors.
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    K Number
    K113674
    Device Name
    SPRAY & CLEAN HANDPIECE CLEANER& LUBRICANT MAXIMA HANDPIECE CLEANER & LUBRICANT EZCARE HANDPIECE CLEANER & LUBRICANT
    Manufacturer
    HANDPIECE HEADQUARTERS INC. - HPR INC.
    Date Cleared
    2012-04-05

    (113 days)

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

    HANDPIECE HEADQUARTERS INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dental Handpiece Cleaner and Lubricant is intended to be used during routine maintenance in order to lubricate and clean air-powered Dental Handpieces (including low speed and high speed) and Dental air motors after each patient use and prior to sterilization. The Dental Handpiece Lubricant is intended to be used during routine maintenance in order to lubricate air-powered Dental Handpieces (including low speed and high speed) and Dental air motors after each patient use and prior to sterilization.
    Device Description
    Dental Handpiece Cleaner and Lubricant (Spray & Clean Handpiece Cleaner & Lubricant, Maxima Handpiece Cleaner & Lubricant, and EZcare Handpiece Cleaner & Lubricant), This is an aerosol product that is used during routine maintenance. It contains two major components, which are Mineral oil and Isopropyl Alcohol. The product lubricates and cleans dental handpieces and air motors when sprayed directly into the air drive tube. It lubricates and cleans out contamination from all internal parts, such as the bearings, gears and auto chucks. Dental Handpiece Lubricant: Maxima Handpiece Lubricant contains mineral oil that drops directly into the air drive tube of the dental handpiece. When the user operates the handpiece, the pressure of air in the air drive tube will deliver the oil into the handpiece to lubricate the bearings, gears, and auto chucks.
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    K Number
    K100389
    Device Name
    HHC PUSH-BUTTON REPLACEMENT TURBINE FOR MIDWEST TRADITION HANDPIECE MODEL MW TURBINE REPLACEMENT
    Manufacturer
    HANDPIECE HEADQUARTERS
    Date Cleared
    2010-08-12

    (177 days)

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

    HANDPIECE HEADQUARTERS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This HHC-Push button air turbine is intended for use with the Midwest Tradition Handpiece in replacement of Midwest Tradition's original turbine. The Dental Handpiece with the HHC- replacement turbine is used by authorized persons in the practice of dentistry. The HHC-replacement turbine is used in the Midwest Tradition High Speed Dental Handpiece, which is intended for removing carious material, cavity preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth.
    Device Description
    The HHC-Push button air turbine is a complete air turbine which will be offered as replacement turbine for Midwest Tradition original turbine. High pressured air directly impacts the blade pockets of the impeller through an air intake tube located inside the handpiece body, which causes the air turbine to rotate at a high speed. The dental cutting bur connects to the turbine's shank (spindle), which rotates at the same speed as the impeller. Cooling water flows through an inlet water tube at high pressure and blows out at an angle near the dental cutting bur to reduce temperature at cutting area.
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    K Number
    K092053
    Device Name
    MAXIMA-M STRAIGHT ATTACHMENT, MAXIMA-M CONTRA ANGLE SHEATH
    Manufacturer
    HANDPIECE HEADQUARTERS
    Date Cleared
    2009-08-20

    (44 days)

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

    HANDPIECE HEADQUARTERS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Straight Attachment and Contra Angle Sheath attachments are used with a Low Speed Dental Handpiece that is intended for removing carious material, cavity and crown preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth. These attachments are used by authorized persons in the practice of dentistry.
    Device Description
    The Straight Attachment or the Contra Angle sheath is used to connect between the low-speed air-driven motor and the handpiece head. (1 to 1)
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    K Number
    K080682
    Device Name
    HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE
    Manufacturer
    HANDPIECE HEADQUARTERS INC. - HPR INC.
    Date Cleared
    2008-09-11

    (185 days)

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

    HANDPIECE HEADQUARTERS INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dental Handpiece is used by authorized persons in the practice of dentistry. This Handpiece is intended for removing carious material, cavity preparations, finishing tooth preparations, reducing hard tooth structures, restorations and polishing teeth.
    Device Description
    The canister handpiece is a complete dental handpiece that includes the turbine (push button & a screw type). The handpiece is fully functional and is being offered in a 4 hole version. High pressured air directly impacts the blade pockets of the impeller through an air intake tube located inside the handpiece body, which causes the air turbine to rotate at a high speed. The dental cutting bur connects to the turbine's sharik (spindle), which rotates at the same speed as the impeller. Cooling water flows through an inlet water tube at high pressure and blows out at an angle near the dental cutting bur to reduce temperature at cutting area.
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