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510(k) Data Aggregation
K Number
K243911Device Name
HPR Cordless Hygiene Handpiece
Manufacturer
Handpiece Headquarters
Date Cleared
2024-12-20
(1 days)
Product Code
EKX
Regulation Number
872.4200Why 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
K233518Device Name
BASE290 LED Curing Light
Manufacturer
Handpiece Headquarters
Date Cleared
2023-11-02
(1 days)
Product Code
EBZ
Regulation Number
872.6070Why 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
K180845Device Name
Maxima Electric System
Manufacturer
Handpiece Headquarters - HPR Inc.
Date Cleared
2019-07-25
(479 days)
Product Code
EBW
Regulation Number
872.4200Why 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
K143183Device Name
Maxima XTEND Handpiece Maintenance System
Manufacturer
HANDPIECE HEADQUARTERS
Date Cleared
2015-02-17
(104 days)
Product Code
EFB
Regulation Number
872.4200Why 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
K141125Device 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
872.4200Why 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
K113674Device 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
872.4200Why 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
K100389Device 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
872.4200Why 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
K092053Device 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
872.4200Why 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
K080682Device 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
872.4200Why 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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