← Product Code LQY · K212178
# Root Apex Locator (K212178)
_Foshan Coxo Medical Instrument Co., Ltd. · LQY · Jul 20, 2022 · DE · SESE_
**Canonical URL:** https://fda.innolitics.com/device/K212178
## Device Facts
- **Applicant:** Foshan Coxo Medical Instrument Co., Ltd.
- **Product Code:** LQY
- **Decision Date:** Jul 20, 2022
- **Decision:** SESE
- **Submission Type:** Traditional
- **Device Class:** Class U
- **Review Panel:** DE
## 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 Story
Root Apex Locator C-ROOT I is an oral device for measuring root canal length. It uses a test wire and file clip to interface with the patient's root canal (compatible with NiTi files). The device processes electrical signals to determine the apex position, displaying results on a 3.5" TFT color touch screen. It is operated by dental personnel in clinical settings. The device provides real-time feedback on apex position, battery status, and connection status. Users can adjust sound, brightness, and reference positions (DR'S CHOICE) via the touch panel. The output assists clinicians in accurately determining the working length during endodontic procedures, potentially improving treatment precision and patient outcomes. The device is powered by a 3.7V Li-ion battery and requires sterilization of patient-contacting components (lip clip, file clip) between uses.
## Clinical Evidence
No clinical data. Bench testing only. Accuracy testing demonstrated measurement precision of ±0.5mm. Biocompatibility testing (ISO 10993-5, -10, -11) and electrical/mechanical safety testing (IEC 60601-1, IEC 60601-1-2, IEC 80601-2-60, IEC 62133-2) confirmed compliance with design specifications.
## Technological Characteristics
Handheld dental device with 3.5" TFT color touch display. Materials: 304 stainless steel (lip hook/file clip), PI (file clip). Power: 3.7V 1800mAh Li-ion battery. Connectivity: Wired test wire/charger. Sterilization: Steam sterilization for patient-contacting components. Standards: ISO 10993, IEC 60601-1, IEC 60601-1-2, IEC 80601-2-60, IEC 62133-2.
## Predicate Devices
- BOMEDENT Apex locator ([K203836](/device/K203836.md))
## Reference Devices
- E-connect S Endo Motor with built-in Apex Locator ([K201993](/device/K201993.md))
## Submission Summary (Full Text)
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July 20, 2022
Foshan COXO Medical Instrument Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5 YiHe North Rd., FangShan District Beijing, Beijing 102401 China
Re: K212178
Trade/Device Name: Root Apex Locator Regulatory Class: Unclassified Product Code: LQY Dated: June 14, 2022 Received: June 21, 2022
# Dear Ray Wang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
510(k) Number (if known)
K212178
Device Name
Root Apex Locator
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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The assigned 510(k) Number:
# 510(k) Summary
This 510(k) Summary was prepared in accordance with the requirements of Title 21, CFR Section 807.92.
- 1. Date of Preparation: 2022/07/14
- 2. Sponsor Identification
## Foshan COXO Medical Instrument Co., Ltd.
BLDG 4, District A, Guangdong New Light Source Industrial Base, South of Luocun Avenue, Nanhai District, Foshan, 528226 Guangdong, China.
Contact Person: Yongjian Zheng Position: Legal Representative Tel: +86-13702544788 Fax: +86-757-81800058 Email: 13702544788@163.com
- 3. Designated Submission Correspondent
Mr. Ray Wang
### Beijing Believe-Med Technology Service Co., Ltd.
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, 102401, China
Tel: +86-18910677558 Fax: +86-10-56335780 Email: Ray.Wang@believe-med.com
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### 4. Identification of Proposed Device
Trade Name: Root Apex Locator Common Name: Locator, Root Apex
Regulatory Information Classification Name: Locator, Root Apex Classification: Unclassified Product Code: LQY Regulation Number: N/A Review Panel: Dental
Indication for use Statement:
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.
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.
The Root Apex Locator C-ROOT I is intended to be sterilized prior to use.
The material composition of root canal files that can be used with the Root Apex Locator C-ROOT I is Nickel titanium (NiTi).
### Identification of Predicate Device(s) 5.
Predicate Device K203836 BOMEDENT Apex locator ChangZhou BoMedent Medical Technology Co.,Ltd
Reference Device: 510(k) Number: K201993 Product Name: E-connect S Endo Motor with built-in Apex Locator
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Manufacturer: Changzhou Sifary Medical Technology Co., Ltd.
- Non-Clinical Test Conclusion 6.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- A ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity
- ISO 10993-10: 2010 Biological Evaluation Of Medical Devices Part 10: Tests For Irritation A And Skin Sensitization.
- > ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
- > IEC 60601-1:2012, Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
- > IEC 60601-1-2:2014, Medical Electrical Equipment-Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility-Requirements And Tests
- > IEC 80601-2-60 Edition 2.0 2019-06 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment;
- > IEC 62133-2 Edition1.0 2017-02 Secondary cells and batteries containing alkaline or other nonacid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
- > IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
### Software Verification and Validation:
FDA software validation guidance "General Principles of Software Validation; Final Guidance for Industry and FDA Staff, Document issued on: January 11, 2002".
Software documentation for moderate level of concern per the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
## Performance Testing:
Accuracy Testing:
Internal test method demonstrated that the apex position measurement accuracy of the proposed Root Apex Locator C-ROOT I meets the requirement of ±0.5mm, the accuracy ±0.5mm is the same as that of reference device E-connect S Endo Motor with built-in Apex Locator (K201993) .
The tests demonstrate substantial equivalence between the proposed device and the reference device.
Cleaning Disinfection Validation and Sterilization of the components of the proposed device according to the FDA Guidance Document-Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, AAMI TIR 12, AAMI ST 81,ISO 17665-1.
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Battery Performance:
Both the proposed devices and the predicate device are powered by rechargeable 3.7V Li-ion battery, and both the Li-ion battery of the proposed device and the predicate device comply with the battery safety standard IEC 62133-2.
The IEC 62133-2 test demonstrates substantial equivalence between the proposed device and the predicate device.
- 7. Clinical Test Conclusion
No clinical study is included in this submission.
- 8. Substantially Equivalent (SE) Comparison
| Item | Proposed Device
K212178 | Predicate Device
K203836 | Reference Device
K201993 | Remark |
|------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device name | Root Apex Locator | BOMEDENT Apex
locator | E-connect S Endo
Motor with built-in
Apex Locator | / |
| Classification
Regulation | Unclassified | Unclassified | 21CRF 872.4200 | Same with the
Predicate Device |
| Classification | Unclassified | Unclassified | Class I | Same with the
Predicate Device |
| Product Code | LQY | LQY | EKX/LQY | SAME |
| Common
Name | Locator, Root Apex | Locator, Root Apex | endodontic treatment
motorized handpiece/
root canal apex
locator | SAME |
| Indications
for 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. | support 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. | E-connect S is a
cordless endodontic
treatment motorized
handpiece with root
canal measuring
capability. It can be
used to enlarge canals
while monitoring the
position of the file tip
inside the canal. It can
be used as a
low-speed motorized
handpiece and device | SAME
Both the proposed
devices, the
predicate device
and the reference
device have the
Indications for use
of detecting the
apex of root canal. |
| | | | for measuring canal
length. This device
must only be used in
hospital environments,
clinics or dental
offices by qualified
dental personnel. | |
| Dimensions | Length: 110mm
Width: 103 mm
Thickness: 21.5mm | Length: 110 mm
Width: 65 mm
Height: 20 mm | 21.5cm × 17.5cm ×
9cm | Difference(1) |
| Cable length | Charger cable: 1.5m
Tester cable: 1.4m | • Charger cable: 1.1m
• Measurement
cables: 1.6 m
• File clip cable: 0.2 m | / | Difference(2) |
| Weight | 270g | 185g | / | Difference(3) |
| Power supply | Li-ion Battery
DC 3.7V 1800mAh | Rechargeable Li-ion
battery
Capacity
950mAh,3.7V | Li-ion battery (DC
3.7V) | Difference(4) |
| Charger | Input: AC 100-240 V,
50/60 Hz
Output: DC 5V 1A
Classification of Protection
against Electric Shock:
Class II ( adaptor ) | • Power supply:100 -
240 VAC
• Frequency:50 - 60 Hz
• Nominal power
output:0.15A
• Electrical safety
class:Class II | / | Same with the
Predicate Device
Same safety level. |
| Means of
input | • Touch screen
• Foldable main unit | • Touch screen
• Foldable main unit | / | Same with the
Predicate Device |
| Display | 3.5" TFT colour display | 3.5" TFT Wide angle
of view LCD | / | Same with the
Predicate Device |
| Adjustment
before
measurement | The DR'S CHOICE Apical
Arrow function enables to
mark an individual
predetermined reference
position at the required
distance from the apex.
This variable apical arrow
can be set between the first
green bar and the last
yellow bar. | In the menu of Ref
Point, the reference
position can be
adjusted from 0.0 –
1.2. | / | Difference(5) |
| Measurement
Accuracy | ±0.5mm | / | -0.5mm to+0.5mm for
Apex position | Same with the
Reference Device |
| Patient | Lip hook: 304 Stainless | Lip Clip: Stainless | Used materials | Difference(6) |
| | | | | |
| contacting
components
materials | steel;
File clip: PI and 304
Stainless steel | Steel
File Clip: Silicone and
stainless steel | conform to ISO10993. | |
| Sterilization | Lip clip and file clip are user sterilized by steam sterilization. | Lip clip and file clip are user sterilized by steam sterilization. | Contra Angle, Lip Hook, File clip, Insulating Sleeve autoclavable. | SAME |
| Applied Standards: | | | | |
| Biocompatibility | ISO10993-5
&ISO10993-10
&ISO10993-11 | ISO10993-5
&ISO10993-10 | ISO10993-5
&ISO10993-10 | Difference(7) |
| Electrical
Safety | IEC 60601-1 | Conform to
IEC60601-1 | Conform to
IEC60601-1 | SAME |
| Mechanical
safety | IEC 60601-1 | Conform to
IEC60601-1 | Conform to
IEC60601-1 | SAME |
| Thermal
safety | IEC 60601-1 | Conform to
IEC60601-1 | Conform to
IEC60601-1 | SAME |
| EMC | IEC 60601-1-2 | Conform to EN
60601-1-2 | Conform to IEC
60601-1-2 | SAME |
| Performance | IEC 80601-2-60 | IEC 80601-2-60 | IEC 80601-2-60
ISO 14457 | Same with the
Predicate Device |
| Material
of
the applicable
root
canal
files | Nickel titanium (NiTi) | Unknown | Unknown | Difference(8) |
## Table 1 General Comparison
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### Analysis:
Difference(1)
The proposed device includes the same main specifications as compared to the predicate device but differs in dimension, which is caused by different appearance design and could not effects the performance and safety.
## Difference(2)
There is a difference in the cable length, but these cables include the same function , the cable length difference would not affect its safety and effectiveness.
### Difference(3)
The proposed device and the predicate device have a different weight, however, this could not effect the performance and safety.
### Difference(4)
Both the proposed device, the predicate device and the reference device are powered by rechargeable 3.7V Li-ion battery, there is a difference in the battery capacity. The proposed device compli es with
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electrical safety standard IEC 60601-1, and its Li-ion battery complies with the battery standard IEC 62133-2, so the difference in battery capacity would not affect its safety and effectiveness.
### Difference(5)
There is a difference on the description of adjustment before measurement, however both the proposed device and the predicate device have the same function, the proposed device does not specify the specific value of the adjustment range, but uses colors to identify the adjustment range, so such description difference would not affect its safety and effectiveness .
### Difference(6)&(7)
Both the Patient contacting components materials of proposed device and predicate device meet the ISO10993-5 &ISO10993-10 standards, and the proposed device also meets the ISO10993-11 standard, the difference would not affect its safety and effectiveness.
### Difference(8)
The material of root canal files that can be used with the predicate device and the reference device are unknown, however, a clinical accuracy study was conducted on the proposed device and root canal file of Nickel titanium (NiTi) material, the result meet the requirement of ±0.5mm measurement accuracy, so the difference would not affect its safety and effectiveness.
### 9. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.
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**Source:** [https://fda.innolitics.com/device/K212178](https://fda.innolitics.com/device/K212178)
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