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510(k) Data Aggregation
K Number
K210475Device Name
EQ-M
Manufacturer
Date Cleared
2022-09-21
(581 days)
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
Meta Systems Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EQ-M motorized handpiece can be used to enlarge and prepare root canals, remove gutta-percha points. When connected to Apex locator (EQ-PEX), the EQ-M can be used to measure the length of root canals.
Device Description
EQ-M is micro motor needed to make canal enlargement for root canal treatment. The battery in the motor handpiece is used as a power source and the rotational power generated by rotating the micro motor is transmitted to the crown gear of the angle head through the bevel gear and shaft. The resulting rotational power is transmitted to the file to rotate the file. When connected to Apex Locator (EQ-PEX), the EQ-M indicates the position of the file tip inside the root canal.
The EQ-PEX is Electronic Apex Locator and accessories to be used to treat patients. It consists of the main body and lip hook, probe cord. The device is used to track the position of the file in the root canal based on the impedance of two different frequencies.
The screen displays measurement information of the root canal length at the current location of the file and displays a number and graph. Stainless steel hand files are intended to be used with the subject device. Lip hook is intended to be placed on the opposite lip of the tooth to be worked on. The file is slowly inserted into the root canal. When the file approaches the apex reference value and alarm will beep and the text apex will appear on the measurement screen.
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K Number
K210789Device Name
EQ-PEX
Manufacturer
Date Cleared
2021-10-20
(218 days)
Product Code
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Meta Systems Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
EQ-PEX is an Electronic Apex Locator designed for use in measuring the working length of root canals.
Device Description
EQ-PEX is Electronic Apex Locator and accessories to be used to treat of patients. It consists of the main body and lip hook, probe cord and 2 kinds of file holder. The device is used to track the position of the file in the root canal based on the impedance of two different frequencies. The device is intended for measuring the length of the root canal treatments. The components of the device include the main body, probe cord, lip book, file holder, AC adapter, and power cord.
The screen displays measurement information of the root canal length at the current location of the file and displays a number and graph. Stainless steel hand files are intended to be used with the subject device. Lip hook is intended to be placed on the opposite lip of the tooth to be worked on. The file is slowly inserted into the root canal. When the file approaches the apex reference value and alarm will beep and the text apex will appear on the measurement screen.
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K Number
K153285Device Name
EMS-200
Manufacturer
Date Cleared
2016-08-12
(274 days)
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
META SYSTEMS CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The EMS-200 is a dental device which combines in a single LCD unit an endo motor which ablates the tooth to expand the root canal, a dental obturator to fill and pressurize various shaped packing elements and an electronic apex locator which assists the operator the location of the front tip in the root canal, for use by trained dental professionals.
Device Description
The EMS -200 dental unit is device that combines the 1) Endo-motor Handpiece (K133298) which ablates the tooth to expand the root canal, a 2) Endodontic Obturation Unit which is used to fill and pressurize various shaped packing elements, and 3) Electronic apex locator (K112508) which is used to ensure the location of the front tip in root canal through changes of electric resistance value into one unit. The working of each of the components is displayed through a single touch screen.
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