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510(k) Data Aggregation
K Number
K242514Device Name
Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)
Manufacturer
Shenzhen Rogin Medical Co., Ltd.
Date Cleared
2025-04-24
(244 days)
Product Code
EKX
Regulation Number
872.4200Why did this record match?
Product Code :
EKX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Endo Motor with E-LITE MAX, E-LITE PRO and ELITE-INO is cordless endodontic treatment motorized handpiece with root canal measurement capability. It can be used for preparation and enlargement of root canals, or measuring the canal length. And it can be used to enlarge the canals while monitoring the position of the file tip inside the canal.
Device Description
### E-LITE MAX & ELITE-INO:
The Endo Motor with E-LITE MAX and ELITE-INO is a low-speed rotating oral equipment mainly used for root canal preparation and root canal measurement. It is designed to enlarge the root canal, facilitate dentin filling, or measuring the root canal length. The product is a portable device consist of a cordless hand-piece and a charge base, it is powered by built-in lithium batteries and charged by the adapter. LCD displays parameters such as speed, torque, file system, Apex etc. Users can also set and modify by keys, and provide design of factory initialization, and calibration of the apex location. It can be used as a low-speed motorized handpiece and device for measuring canal length. The rotary speed and torque range are adjustable.
There are three function features for E-LIT MAX and ELITE-INO:
- Root Canal enlargement: Prepare the root canal with apex locator function.
- Apex Location: Measure the length of the root canal.
- Multi-function: Measuring the length while root canal preparation.
The device can save 9 programs, each program can set different parameters according to the user.
### E-LITE PRO:
The Endo Motor with E-LITE PRO is a low-speed rotating oral equipment mainly used for root canal preparation. It is designed to enlarge the root canal or facilitate dentin filling. The product is a portable device having a cordless hand-piece with a charging adapter, it is powered by built-in lithium batteries and charged by the adapter. LCD displays parameters such as speed, torque, file system, Apex etc. Users can also set and modify by keys, and provide design of factory initialization, and calibration of the apex location. It can be used as a low-speed motorized handpiece and device for measuring canal length. The rotary speed and torque range are adjustable.
There is only one function features for E-LITE PRO:
- Root Canal enlargement: Prepare the root canal, without apex locator function.
The device can save 9 programs, each program can set different parameters according to the user.
The Endo Motor must only be used in hospital environments, clinics or dental offices by qualified dental personnel.
The Endo Motor is intended to be sterilized prior to use.
The compatible device can be used with Endo Motor is rotary instruments such as rotary root canal files, the working part of rotary instruments normally made of Nickel titanium (NiTi). These files are not included in the submission.
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K Number
K241065Device Name
ChecQ (AC100)
Manufacturer
DENTIS Co., Ltd.
Date Cleared
2025-03-21
(337 days)
Product Code
EKX
Regulation Number
872.4200Why did this record match?
Product Code :
EKX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ChecQ is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region.
Device Description
The ChecQ is a dental implant stability analyzer comprising a main unit and a charging cradle that uses Resonance Frequency Analysis (RFA) to measure implant stability non-invasively. It works with the ChecQPEG, which attaches to the dental implant, and measures stability by analyzing resonant frequencies generated by magnetic field stimulation from the probe tip. The stability result is displayed on the main unit's screen as an Implant Stability Quotient (ISQ), ranging from 1 to 99. The RFA method evaluates by applying transverse force to the implant using magnetism, measuring movement, and analyzing the resulting resonance frequency. The resonance frequency depends on the bone-implant gap and is calculated using a formula, with values expressed as ISQ scores (1-99) for clinical interpretation. The ChecQ mechanism converts voltage pulses generated by the DAC of the MCU into magnetic pulses, which induce vibrations in the ChecQPEG magnets. The device captures the free vibrations as magnetic pulses, processes them through an FFT to extract the natural frequency, and calculates the ISQ value based on this frequency.
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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?
Product Code :
EKX
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
K222688Device Name
The Trust
Manufacturer
Genoss Co., Ltd
Date Cleared
2024-08-09
(703 days)
Product Code
EKX
Regulation Number
872.4200Why did this record match?
Product Code :
EKX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Trust is indicated for use in measuring the stability of implants in the oral cavity and maxillofacial region. The Trust is restricted to usage with Dentium implant system, and the angle of the abutment must be maintained at 90° when in use.
Device Description
This equipment measures the time between the healing abutment and the striking rod by mechanically striking the implanted abutment and quantifies the fluctuation between the implant abutment and the alveolar bone. It is a principle to measure the contact time according to the acceleration change at the moment of being hit by using the acceleration sensor mounted on the Attack Pole. The higher the number, the better the fixation between the implant fixture and the bone.
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K Number
K233865Device Name
X-Smart Pro; X-Smart Pro+
Manufacturer
Dentsply Sirona Inc.
Date Cleared
2024-07-24
(231 days)
Product Code
EKX, LQY
Regulation Number
872.4200Why did this record match?
Product Code :
EKX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Endo Tabletop consists of a motorized endodontic handpiece for root canal cleaning and preparation. In addition, some models may also incorporate an electronic apex locator that assists the operator to locate the file tip in the root canal. The Endo Tabletop is intended solely for use by trained dental professionals on patients that need root canal treatment.
Device Description
The Endo Tabletop is designed to drive dental endodontic instruments for a rotating treatment of root canals. Therefore, the Endo Tabletop provides different kinds of movement:
1. Continuous rotary motions (adjustable speed, torque and direction depending on the file used)
2. Reciprocating motions (speed, torque, direction, and angles depending on the file used)
This functionality is provided by a Brushless Direct Current (BLDC) motor having speed and torque controls. The motor speed control is driven by a dedicated controller using pulse width modulation (PWM) of the excitation voltage and the motor torque control is performed by controlling and limiting the maximum current flow. The contra-angle transmits the motor movement in speed and direction to the endodontic file.
The user can set the device by a graphical user interface on a 7" touch Thin-Film Transistor (TFT) display. The handpiece can be started/ stopped with a finger switch and foot control.
All models can also be used for root canal length determination using the integrated apex locator functionality. This apex locator functionality is provided by evaluating the electical impedance between to the file clamp, placed into the dental root canal and the lip clip placed on the patient. The results of this estimation must be confirmed by standardized diagnostic imaging like an X-ray.
The proposed apex locator function has two modes standalone mode. In standalone mode, the apex determination works with the lip and the endodontic file, which is connected to a file clamp. In combined mode, the apex determination works with the lip clip and the endodontic file which is connected to the contra-angle.
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K Number
K232551Device Name
EM-07 Cordless Endo Motor
Manufacturer
Forum Engineering Technologies (96) Ltd.
Date Cleared
2024-07-09
(321 days)
Product Code
EKX, LQY
Regulation Number
872.4200Why did this record match?
Product Code :
EKX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EM-07 is a cordless handpiece with apex localization capability, used for driving files in both continuous rotation and reciprocating mode during an endodontic procedure for enlargement of root canals, while monitoring the position of the endodontic file tip within the canal.
Device Description
The EM-07 is a cordless handpiece with apex localization capability.
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K Number
K232810Device Name
Dental Handpiece, Wireless Endodontic Handpiece, endoit
Manufacturer
Micro-NX Co., Ltd.
Date Cleared
2023-11-09
(58 days)
Product Code
EKX
Regulation Number
872.4200Why did this record match?
Product Code :
EKX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dental Handpiece, Wireless Endodontic Handpiece, endoit, model no. (EH-C500) is intended for the removal of carious material, reducing of hard tooth structure, cavity and crown preparations, root canal preparations, removal of fillings, processing and finishing tooth preparations, and restorations for polishing teeth.
Device Description
Dental Handpiece, Wireless Endodontic Handpiece, endoit (model number: EH-C500) consists of a Main Body, connectable Contra Angle, Charging Cradle, and AC/DC Adapter. The Main Body of the handpiece is used for transmitting rotational force required in general dental treatment. The torque transmitted from a wireless electric micro-motor gets further transmitted to the joint part of the device. The rotational force is then decelerated according to the speed reducer of the gear which is transmitted to the head of the dental handpiece. The rotational force is transmitted under the permitted rotation mechanism.
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K Number
K232657Device Name
InnerView LC
Manufacturer
Perimetrics, Inc
Date Cleared
2023-09-01
(1 days)
Product Code
EKX
Regulation Number
872.4200Why did this record match?
Product Code :
EKX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The InnerView LC is intended to precisely measure the damping characteristic of the periodontium and its associated fixed structures (teeth and/or implants). It can provide data to quantify tooth and/or dental implant mobility.
Device Description
The InnerView LC is an electromagnetically driven percussion system used to collect the percussion data of teeth and/or implants by the dental professional. The system is indicated to precisely measure the damping characteristics of the periodontium and its associated fixed structures (teeth and/or implants). It can provide data to quantify tooth and/or dental implant mobility.
The InnerView LC consists of a wireless hand-held handpiece, base station, disposable film tip, and software. A USB cable provides a connection from the base station to a PC.
The device utilizes non-invasive quantitative percussion diagnostics (QPD), a mechanics-based methodology that tests the damping capability, and consequently mobility of teeth and dental implants by lightly percussing their buccal surface. The percussion data generated by the handpiece is wirelessly transferred to the base station and forwarded to the USB connection. In addition, the base station acts as a handpiece battery charger when the handpiece is docked. The device requires a fresh single use disposable film tip to be attached to the handpiece prior to each new procedure.
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K Number
K220829Device Name
Endo Motor
Manufacturer
Foshan COXO Medical Instrument Co., Ltd.
Date Cleared
2023-05-18
(422 days)
Product Code
EKX, LQY
Regulation Number
872.4200Why did this record match?
Product Code :
EKX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
C-SMART-I PRO, C-SMART-I PILOT, C-SMART-MINI AP:
The Endo Motor device is an endodontic treatment motorized handpiece with root canal measurement capability. It can be used to enlarge the canals while monitoring the position of the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.
C-Smart-mini:
The Endo Motor device is an endodontic treatment motorized handpiece. It can be used to enlarge canals. It can be used as a low-speed motorized handpiece. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.
Device Description
C-SMART-I PRO: The Endo Motor device C-SMART-I PRO is a low-speed rotating oral equipment mainly used for root canal preparation and root canal measurement. The product is a portable device powered by built-in lithium batteries and charged by the adapter. LCD displays parameters such as speed, torque, working mode, apex position, etc. Users can also set and modify by keys, and provide design of factory initialization, calibration and functional check of the apex locator. The Endo Motor device is an endodontic treatment motorized handpiece with root canal measurement capability. It can be used to enlarge the canals while monitoring the position of the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel. The Endo Motor device C-SMART-I PRO is intended to be sterilized prior to use. The material composition of root canal files that can be used with the Endo Motor device C-SMART-I PRO is Nickel titanium (NiTi). These files are not included in the submission. There are three working modes as: M1: Apex locator only. M2: Motor only. M3: (Dual mode) Motor with apex location function.
C-SMART-I PILOT: The Endo Motor device C-SMART-I PILOT is a low-speed rotating oral equipment mainly used for root canal preparation and root canal measurement. The product is a portable device powered by built-in lithium batteries and charged by the adapter. LCD displays parameters such as speed, torque, working mode, apex position, etc. Users can also set and modify by keys, and provide design of function check, calibration, factory reset and can connect handpiece to control unit via Bluetooth. The Endo Motor device is an endodontic treatment motorized handpiece with root canal measurement capability. It can be used to enlarge the canals while monitoring the position of the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel. The Endo Motor device C-SMART-I PILOT is intended to be sterilized prior to use. The material composition of root canal files that can be used with the Endo Motor device C-SMART-I PILOT is Nickel titanium (NiTi). These files are not included in the submission. There are three working modes as: Endo motor mode: root canal preparation. Apex locator mode: root canal length measurement. Multi-function mode: undertake root canal measurement and preparation.
C-SMART-MINI AP: The Endo Moto device C-SMART-MINI AP is a low-speed rotating oral equipment mainly used for root canal preparation and root canal measurement. The product is a portable device powered by built-in lithium batteries and charged by the adapter. LCD displays parameters such as speed, torque, apex position, etc. Users can also set and modify by keys, and provide design of functional check, calibration, set dominant hand and factory reset. The Endo Motor device is an endodontic treatment motorized handpiece with root canal measurement capability. It can be used to enlarge the canals while monitoring the position of the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel. The Endo Motor device C-SMART-MINI AP is intended to be sterilized prior to use. The material composition of root canal files that can be used with the Endo Motor device C-SMART-MINI AP is Nickel titanium (NiTi). These files are not included in the submission. There are three working modes as: Endo motor: Prepare the root canal, without apex locator function. Apex Locator: Measure the length of the root canal, without motor function. Multi-function: Measuring the length while root canal preparation.
C-Smart-mini: The Endo Motors device C-Smart-mini is a low-speed rotating oral equipment mainly used for root canal preparation. The product is a portable device powered by built-in lithium batteries and charged by the adapter. LCD displays parameters such as speed, torque, rotary files program, etc. Users can also set and modify by keys, and provide design of calibration and screen display for right- or left-handed user. The Endo Motor device is an endodontic treatment motorized handpiece. It can be used to enlarge the canals. It can be used as a low-speed motorized handpiece. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel. The Endo Motor device C-Smart-mini is intended to be sterilized prior to use. The material composition of root canal files that can be used with the Endo Motor device C-Smart-mini is Nickel titanium (NiTi). These files are not included in the submission.
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K Number
K222548Device Name
Endo Motor
Manufacturer
Shenzhen Perfect Medical Instruments Co., Ltd.
Date Cleared
2023-04-26
(246 days)
Product Code
EKX, LOY, LQY
Regulation Number
872.4200Why did this record match?
Product Code :
EKX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Endo Motor, model: ZR-Rap, is a cordless endodontic treatment motorized handpiece with root canal measuring capability. It can be used to enlarge canals while monitoring the file tip inside the canal. It can be used as a low-speed motorized handpiece and device for measuring canal length.
This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel.
Device Description
The Endo Motor, model: ZR-Rap, is a battery-driven handpiece with a motor, equipped with a chuck for holding rotary instruments such as a dental file. The Endo Motor can be used for enlargement and preparation of root canals and can also be used as an apex locator.
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