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510(k) Data Aggregation
K Number
K242383Device Name
Apex Locator
Manufacturer
Shenzhen Rogin Medical Co., Ltd.
Date Cleared
2025-03-07
(207 days)
Product Code
LQY
Regulation Number
N/AWhy did this record match?
Product Code :
LQY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Apex Locator is used to detect the apex of root canal. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.
Device Description
Apex Locator is an oral equipment used for root canal measurements. It features an LCD color display with functional buttons, enabling users to conveniently view parameters such as battery status, test wire connection status, and apex position etc. Users can easily adjust sound level, brightness, and reference settings using intuitive buttons, and perform functional checks of both the device and cable. The device is intended to be sterilized prior to use.
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K Number
K242765Device Name
Electronic Apex Locator (Alpha Apex I)
Manufacturer
Shenzhen Superline Technology Co., Ltd.
Date Cleared
2025-01-17
(126 days)
Product Code
LQY, LOY
Regulation Number
N/AWhy did this record match?
Product Code :
LQY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Electronic Apex Locator is used to support the determination of the working length during the endodontic treatment. The use of this product is intended exclusively for duly qualified dental practitioners.
Device Description
The Electronic Apex Locator is a microprocessor-controlled device used for root canal length determination. The Electronic Apex Locator assesses the electrical resistance of the tooth and surrounding tissues while the file is inserted and moving along the root canal. By detecting the change of the impedance value of the tooth apex to the AC current response of two different frequencies, two signals are output that are proportional to the change of the AC current response of two different frequencies corresponding to the tooth apex, and the two response signals are compared, and the digital quantity of their ratio is output. The digital quantity represents the position of the electrode at the tooth apex.
Advanced user interface implemented in Electronic Apex Locator is based on high resolution TFT (Thin Film Transistor) color graphic display. It provides presentation of endodontic file movement inside the canal. In addition, the interface displays the mute or volume level and power status.
The product is functionally operated by three buttons: 1) On/off button of the main unit: Short press once to hear a beep is to start up the machine, short press once again to shut down, and long press no response. 2) Volume button: Under the startup state, press once to increase one volume. After reaching the maximum volume, press once to enter the mute mode. Press four times as a cycle, and there will be no responds when long press. 3) DEMO button: Under the startup state, long press to enter the DEMO process, and the screen will demonstrate the process of measuring the length.
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K Number
K231990Device Name
Apex Locator
Manufacturer
Cefla S.C.
Date Cleared
2024-02-13
(223 days)
Product Code
LQY
Regulation Number
N/AWhy did this record match?
Product Code :
LQY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
APEX LOCATOR is a device intended for locating the apex of the root canal during endodontic treatments.
Device Description
APEX LOCATOR is a device used in dentistry to estimate the position of the root apex of teeth during root canal preparation. It is used connected with the Cefla dental units. Its principle of operation relies on measuring the electrical impedance of dental tissue, which varies according to tissue density and composition. The APEX LOCATOR is an accessory device for the Cefla dental units used to estimate the position of the root apex of teeth during root canal preparation. The kit is composed of the following elements: file clip (2 pieces), lip hook (4 piece), external wiring (1 piece).
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K Number
K232717Device Name
Apex Locator (AL-Pex), Apex Locator (AL-Pex+)
Manufacturer
Changzhou Haili Medical Co., Ltd.
Date Cleared
2023-12-22
(108 days)
Product Code
LQY
Regulation Number
N/AWhy did this record match?
Product Code :
LQY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
support the dentist in the determination of the working the endodontic treatment. The use of this product is intended exclusively for duly qualified dental practitioners.
Device Description
Apex locators are equipment used for working length measurement during root canal treatment. The devices are powered by a built-in lithium battery, can be charged by a USB adaptor. The devices employ a LCD screen to display the status of file in the root canal and the relative distance between file tip and reference point.
The devices are reusable medical devices initially supplied as non-sterile to the user and requiring the user to clean and disinfect the surface of device. And their accessory, Dental root canal file clip, Dental lip hook and probe are reusable, initially supplied as non-sterile to the user, and requiring the user to sterile for initial use, as well as to reprocess after each use.
The devices include a main unit, a measurement wire A, a measurement wire B, a dental root canal file clip, a dental lip hook, a probe and an adaptor.
Main unit: measure and display working length.
Measurement wire A: connect file clip and lip hook with main unit.
Measurement wire B: connect lip hook and main unit with EM-Motor root canal preparation device.(The EM-Motor root canal preparation device is not included with the subject device and is sold separately.)
File clip: Connect to file.
Lip hook: hook patient's lip.
Touch Probe: promote to measure molar.
Power Adapter: use for charging.
Tester: use for checking whether the device is normal.
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K Number
K212178Device Name
Root Apex Locator
Manufacturer
Foshan COXO Medical Instrument Co., Ltd.
Date Cleared
2022-07-20
(373 days)
Product Code
LQY
Regulation Number
N/AWhy did this record match?
Product Code :
LQY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Root Apex Locator is used to detect the apex of root canal. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.
Device Description
The Root Apex Locator C-ROOT I is a oral equipment used for root canal measurement. The device includes a TFT colour display with touch panel displays parameters such as battery status, connection status of test wire and apex position, etc. Users can also set and modify the sound level, brightness level, DR'S CHOICE via a touch panel, and provide a functional check of the device and cable.
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K Number
K210789Device Name
EQ-PEX
Manufacturer
Meta Systems Co., Ltd.
Date Cleared
2021-10-20
(218 days)
Product Code
LQY
Regulation Number
N/AWhy did this record match?
Product Code :
LQY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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
K203836Device Name
BOMEDENT Apex locator, WISMY Apex locator
Manufacturer
ChangZhou BoMedent Medical Technology Co., Ltd
Date Cleared
2021-03-30
(90 days)
Product Code
LQY, LOY
Regulation Number
N/AWhy did this record match?
Product Code :
LQY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BOMEDENT Apex locator and WISMY Apex locator support the determination of the working length during the endodontic treatment. The use of this product is intended exclusively for duly qualified dental practitioners.
Device Description
The proposed BOMEDENT Apex locator and WISMY Apex locator are microprocessor-controlled devices can support the dentist during endodontic treatments for the proximity of the file to the reference point for endodontic working length determination. To do so, the proposed BOMEDENT Apex locator and WISMY Apex locator assess the electrical resistance of the tooth and surrounding tissues while the file is inserted and moving along the root canal. The proposed BOMEDENT Apex locator and WISMY Apex locator products configuration consist of the following components: (1) Power Adapter (2) USB cable (3) Measuring cable A (4) File clip (5) Lip hook (6) Measuring cable C (Optional)
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K Number
K191806Device Name
Propex IQ Apex Locator
Manufacturer
Dentsply Sirona
Date Cleared
2019-10-03
(90 days)
Product Code
LQY, LOY
Regulation Number
N/AWhy did this record match?
Product Code :
LQY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Propex IQ® Apex Locator supports the dentist in the determination of the working length during the endodontic treatment. The use of this product is intended exclusively for duly qualified dental practitioners.
Device Description
The proposed Propex IQ® Apex Locator is a microprocessor-controlled device that supports the dentist during endodontic treatments for the determination of the file to the reference point for endodontic working length determination. To do so, the proposed Propex IQ® Apex Locator assesses the electrical resistance of the tooth and surrounding tissues while the file is inserted and moving along the root canal. The proposed Propex IQ® Apex Locator product configuration consists of the following components:
- The proposed Propex IO® Apex Locator
- The proposed Propex IQ® Apex Locator Measurement cable
- The Proposed X-Smart IO® Measurement Cable
- The proposed Propex IQ® Apex Locator External Tester
- The Propex IQ® Disposable Barrier Sleeve
- The proposed Propex IQ® Lip clip
- The proposed Propex IQ® File clip
- The proposed Propex IQ® Clamp
- Propex IQ® Charger and AC Adapter Plugs
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K Number
K181087Device Name
Apex Locator, DPEX III
Manufacturer
Guilin Woodpecker Medical Instrument Co., Ltd.
Date Cleared
2018-12-18
(237 days)
Product Code
LQY
Regulation Number
N/AWhy did this record match?
Product Code :
LQY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Apex Locator, DPEX III is a microprocessor controlled device intended for locating the apex of root canal.
Device Description
Apex Locator, DPEX III is an apex locator intended for precise localization of root canal apex. Operation of Apex Locator, DPEX III is fully automatic, no manual calibrations or adjustments are required. The measuring signal is analyzed, and automatic adjustments are made if needed. The device may operate within different conditions in the root canal. Apex Locator, DPEX III may only be used with stainless steel or nickel titanium endodontic files. The scale indication on the apex locator screen does not represent a distinct length or distance in mm or other linear units. It merely indicates the file progression towards the apex.
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K Number
K171867Device Name
Drs Finder NEO
Manufacturer
Good Doctors Co.,Ltd.
Date Cleared
2018-03-30
(281 days)
Product Code
LQY, LOY
Regulation Number
N/AWhy did this record match?
Product Code :
LQY
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dr's Finder NEO is intended for detecting the apex of root canal.
Device Description
The device allows the relative position of a dental file and the apex to be determined electrically. Using a standard dental file inserted into the root canal as an electrode, the device emits very small electrical currents having frequencies of 400 Hz, and 10400 Hz. The current between the file and mouth is measured at each of these frequencies, and the readout of the relative proximity to the apex will appear on the meter.
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