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510(k) Data Aggregation
K Number
K213897Device Name
Pro M Class
Manufacturer
Date Cleared
2022-09-19
(279 days)
Product Code
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
Saeyang Microtech Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PRO M CLASS is used by dental professionals for orthodontic procedures using a root canal instrument and tightening and loosening an abutment screw to fix and remove the abutment on a dental implant in prosthodontic treatment.
Device Description
The PRO M CLASS is an AC-powered device that includes a 'Motor Handpiece', 'Contra angle Handpiece', 'Charger unit' and 'AC/DC Adaptor' for grinding, cutting, polishing and screw driver work in dental oral use. The PRO M CLASS uses the battery inside the motor handpiece as a power source to rotate the micromotor to transmit the generated rotational power to the contra angle. Dental treatment is performed using the rotational power obtained by this. The motor turned by the power converted into DC 5.0V by controller delivers its turning power to the file through spin to perform punching, cutting and removing functions. The hand-piece can be operated, stopped and set/adjusted on/in its speed, torque and turning direction by handling of the controller.
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K Number
K193340Device Name
GoChek Blood Glucose Monitoring System, GoChek Connect Blood Glucose Monitoring System
Manufacturer
Date Cleared
2020-09-11
(284 days)
Product Code
Regulation Number
862.1345Why did this record match?
Applicant Name (Manufacturer) :
MicroTech Medical, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
GoChek Blood Glucose Monitoring System
The GoChek Blood Glucose Monitoring System comprises of the GoChek Blood Glucose Meter and GoChek Blood Glucose Test Strips. The GoChek Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips. The GoChek Blood Glucose Monitoring System is intended for self-testing by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. The GoChek Blood Glucose Monitoring System is intended for single-patient use and should not be shared.
The GoChek Blood Glucose Monitoring System is for in vitro diagnostic use. The GoChek Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes.
GoChek Connect Blood Glucose Monitoring System
The GoChek Connect Blood Glucose Monitoring System comprises of the GoChek Connect Blood Glucose Meter and GoChek Blood Glucose Test Strips. The GoChek Connect Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose in fresh capillary whole blood from the fingertips. The GoChek Connect Blood Glucose Monitoring System is intended for self-testing by people with diabetes at home as an aid in monitoring the effectiveness of diabetes control programs. The GoChek Connect Blood Glucose Monitoring System is intended for single-patient use and should not be shared.
The GoChek Connect Blood Glucose Monitoring System is for in vitro diagnostic use. The GoChek Connect Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes.
Device Description
GoChek Blood Glucose Monitoring System and GoChek Connect Blood Glucose Monitoring System (also called "GoCheck series") perform quantitative assays of glucose in fresh capillary whole blood obtained from the fingertip. The glucose measurement is achieved by using the amperometric detection method.
Both the systems share the same GoChek Blood Glucose test strips. It has a reagent system in test window that includes glucose dehydrogenase (FAD-GDH) and a mediator that reacts with the glucose in the whole blood sample. This reaction, in turn produces an electrical current that is measured by the meter's electronics through test strip contact area. The meter, then calculates and displays the blood glucose concentration reading, calibrated to a plasma reference.
GoChek Connect Blood Glucose Monitoring System has Bluetooth and serial interfaces that comply with US federal guidelines, Part 15 of the FCC Rules for devices with RF capability. This Bluetooth function will allow user to transfer their test results from BG meter to a specific app which developed by MicroTech. Users can choose to utilize these function by following the instruction to set it up, otherwise these functions will remain shut off.
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K Number
K141482Device Name
KI-20
Manufacturer
Date Cleared
2015-04-24
(324 days)
Product Code
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
SAEYANG MICROTECH CO LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For use in a wide range of dental procedures including; endodontic surgeries, such as drilling into the tooth canal, and general dentistry, such as removing carious material from the dentin.
Device Description
The Ki-20 is designed to use in dental surgery. It consists of an E-type motor (DC 28V Operation Motor), handpieces, a control box, a foot switch and other accessories. It is designed that the speed and direction of the handpiece can be controlled by the control box and the foot switch. The irrigation tube and the pump are used to supply the cooling water for the successful surgery.
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K Number
K123582Device Name
ENDO A CLASS
Manufacturer
Date Cleared
2013-08-16
(269 days)
Product Code
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
SAEYANG MICROTECH CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This application area extends to endodontic procedures using a root canal instrument which is intended by the manufacturer for use in the mechanical and rotary preparation of root canals.
Device Description
The motor turned by the power converted into DC2.4V by controller delivers its turning power to the file through spin to perform punching, cutting and removing functions. The hand-piece can be operated, stopped and set/adjusted on/in its speed, torque and turning direction by handling of the controller.
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K Number
K123608Device Name
ENDO E CLASS
Manufacturer
Date Cleared
2013-08-16
(268 days)
Product Code
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
SAEYANG MICROTECH CO
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
For use in a wide range of dental procedures including; endodontic surgeries, such as drilling in to the tooth canal, and general dentistry, such as removing carious material from the dentin.
Device Description
The motor turned by the power converted into DC24V by controller delivers its turning power to the bur through spin to perform punching, cutting and removing functions. The hand-piece can be operated, stopped and set/adjusted on/in its speed, torque and turning direction by handling of the controller.
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K Number
K032967Device Name
PASCAL DYNAMIC CONTOUR TONOMETER
Manufacturer
Date Cleared
2003-11-14
(52 days)
Product Code
Regulation Number
886.1930Why did this record match?
Applicant Name (Manufacturer) :
SMT SWISS MICROTECHNOLOGY AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The PASCAL™ Dynamic Contour Tonometer is a diagnostic device that serves for measuring intraocular pressure (IOP), according to the Contour Tonometry method. The device is also capable of measuring short term pressure fluctuations. PASCAL™ is specially indicated in Glaucoma.
Device Description
Not Found
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K Number
K022535Device Name
MICROTECH PUSH BUTTON HANDPIECE, MODEL MHS-A100
Manufacturer
Date Cleared
2002-10-22
(83 days)
Product Code
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
MICROTECH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
This handpiece is to be used for intra and extra orally to cut, shape, grind and polish teeth, or items related to teeth and dental devices that may be in the mouth or to be placed in the mouth.
Device Description
Microtech Push Button Handpiece
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