(581 days)
No
The description focuses on mechanical and electrical principles (motor rotation, impedance measurement) for root canal procedures and length measurement. There is no mention of AI/ML terms, image processing, or data-driven learning processes.
Yes
The device is used to enlarge and prepare root canals, which are therapeutic actions for endodontic treatment.
Yes
The EQ-PEX, when connected to the EQ-M, functions as an electronic apex locator that measures the length of root canals and indicates the position of the file tip. This involves tracking the file's position based on impedance and displaying measurement information, which are diagnostic functions.
No
The device description clearly details hardware components such as a micro motor, battery, gears, shaft, angle head, main body, lip hook, and probe cord, indicating it is a physical device with software functionality, not a software-only device.
Based on the provided information, the EQ-M motorized handpiece itself is not an IVD.
Here's why:
- IVD Definition: In Vitro Diagnostics (IVDs) are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- EQ-M's Function: The EQ-M is a mechanical device used within the body (in the root canal) to physically enlarge and prepare the canal and remove material. It does not analyze specimens taken from the body.
However, the EQ-PEX Electronic Apex Locator, when connected to the EQ-M, could be considered an IVD component or a device with an IVD function.
Here's why:
- EQ-PEX's Function: The EQ-PEX measures the impedance within the root canal to determine the position of the file. While it's not analyzing a traditional "specimen" like blood, it is using a physiological characteristic (impedance) within the body to provide diagnostic information (root canal length).
- Intended Use: The intended use explicitly states that when connected to the EQ-PEX, the EQ-M can be used to "measure the length of root canals." This measurement is a diagnostic step in the root canal treatment process.
In summary:
- EQ-M (motorized handpiece alone): Not an IVD.
- EQ-PEX (Electronic Apex Locator): Has an IVD function as it provides diagnostic information (root canal length) by measuring physiological characteristics within the body.
- EQ-M and EQ-PEX used together: The system as a whole performs a diagnostic function (measuring root canal length) and a therapeutic function (preparing the canal). The diagnostic component (EQ-PEX) would likely be regulated as an IVD or a device with an IVD function.
The fact that the predicate device (K112665 Tri Auto mini) and reference device (K170275 Tri Auto ZX2) are also combined motorized handpieces and apex locators further supports the idea that the apex locator component is considered a diagnostic function.
N/A
Intended Use / Indications for 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.
Product codes
EKX, LQY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
root canals
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-Clinical Study performance: To be in compliance with electromagnetic safety and compatibility, appropriate study has been applied to the subject device in accordance with the following standard
- ISO 14971:2007 Medical devices Application of risk management to medical devices
- IEC 60601-1:2005 + A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014 Medical electrical equipment - Part1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests
- IEC 60601-1-6: 2010/AMD1:2013 Medical electrical equipment - Part 1-6: General requirements for safety and essential performance - Collateral standard: Usability
- IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
- IEC 62304:2006+A1:2015 Medical device software - Software life cycle processes
- IEC 62133-2:2017 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications
- ISO 15223-1:2021 Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
- ISO 7010:2019 Graphical symbols - Safety colors and safety signs - Registered safety signs
- ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Test for in vitro cytotoxicity
- ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- ISO 11737-1:2018 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products
- IEC 80601-2-60:2019 Medical electrical equipment - Part 2-60: Particular requirements for basic safety and essential performance of dental equipment
- ISO 14457:2017 Dentistry - handpieces and motors
- ISO 1797:2017 Dentistry - Shanks for rotary and oscillating instruments
- ISO 7405:2018 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
- FDA Reprocessing Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling
- FDA Software Guidance Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Key Metrics
Accuracy of the root apex locator function: -0.5mm to +0.5mm from Apex position
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.4200 Dental handpiece and accessories.
(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 21, 2022
Meta Systems Co., Ltd % Yang Ho Dong Manager Onbix Corporation #821 Samil Plaza, 14 Dogok-ro 1-gil, Gangnam-gu Seoul, 06253 SOUTH KOREA
Re: K210475
Trade/Device Name: EQ-M Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EKX, LQY Dated: August 16, 2022 Received: August 23, 2022
Dear Yang Ho Dong:
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.
1
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 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.
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 Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210475
Device Name EQ-M
Indications for Use (Describe)
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.
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY K210475
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR ઠુક્ષ્ઠ07.92.
| Submitter Information: | Meta Systems Co., Ltd
#1214-18, Sicox tower 12F, 484, Dunchon-daero,
Jungwon-gu, Seongnam-si, Gyeonggi-do, 13229, Korea
Tel. +82-31-731-7377 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ho Dong, Yang
Onbix Corporation
#821 Samil Plaza, 14 Dogokro 1-gil
Gangnam-gu, Seoul, Korea (06253)
Tel: *82-2-566-3360 / Fax: *82-2-6280-3360
Email: onbix@naver.com |
| Date Summary Prepared: | Sep 16, 2022 |
| Device Information: | |
| Trade Name(s): | EQ-M |
| Common/Usual Name: | Dental Endo Motor |
| Classification Name: | handpiece, direct drive, ac-powered |
| Regulation Class: | Class 1 |
| Panel: | Dental |
| Regulation Number: | 872.4200 |
| Primary Product Code: | FKX |
Predicate Device Information:
Additional Product Code:
| K number | Device name | Manufacturer | |
|---|---|---|---|
| Primary Predicate | |||
| Device | K112665 | Tri Auto mini | J. MORITA MFG. |
| CORP | |||
| Reference Device | K170275 | Tri Auto ZX2 | J. MORITA MFG. |
| CORP |
LQY
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.
4
Indications for Use:
The EQ-M motorized handpiece can be used to enlarge and prepare root canals, remove guttapercha points. When connected to Apex locator (EQ-PEX), the EQ-M can be used to measure the length of root canals.
Comparison to Predicate Device(s):
This device is equivalent to the predicate devices in its intended use and technological characteristics, including:
-
- indications for use
-
- technological characteristics
-
- performance properties
Summary of the technological characteristics compared to the predicate device
Subject device is substantially equivalent to the predicate device in its technological characteristics stated in the comparison table as attached.
Comparison of Technical characteristics
| Features | Subject Device | Primary
Predicate Device | Reference Device | Comparison | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|--|
| Product name | EQ-M | Tri Auto mini | Tri Auto ZX2 | - | |
| 510(k) number | - | K112665 | K170275 | - | |
| Applicant | Meta Systems Co.,
Ltd. | J. MORITA MFG.
CORP. | J. MORITA MFG.
CORP. | - | |
| Primary
Product Code | EKX | EKX | EKX | Same. | |
| Additional
Product Code | LQY | - | LQY | Same | |
| Components | Handpiece, Contra
angle, Battery,
Battery charger,
Power Cord,
AC/DC Adapter | Handpiece, Contra
angle, Battery,
Battery charger,
Power Supply Cord | Handpiece, Contra
angle, Battery
Charger, AC
Adapter, Contrary
Electrode, File
Holder, Probe Cord | Same | |
| Operation with
Apex Locator | 1. Connect Contra
angle
2. File installation
3. Connect the
handpiece to the
Apex Locator with a
Transmission cable
(probe cord).
4. The
measurement bar
shows the location
of the file tip.
5. Hook the
Contrary Electrode
(Lip hook) in the
corner of the
patient's mouth.
6. Operate the
handpiece.
7. If the file tip goes
past the Flash bar, | 1. Connect Contra
angle
2. File installation
3. Connect the
handpiece to the
Apex Locator with a
Transmission
cable.
4. The
measurement bar
shows the location
of the file tip.
5. Hook the
Contrary Electrode
in the corner of the
patient's mouth.
6. Operate the
handpiece.
7. If the file tip goes
past the Flash bar,
an alarm will sound | 1. Connect Contra
angle
2. File installation
3. Connect the
probe cord to the
motor handpiece.
4. Connect the file
holder and the lip
hook to the probe
cord respectively.
5. The
measurement bar
shows the location
of the file tip.
6. Hook the
Contrary Electrode
in the corner of the
patient's mouth.
7. Operate the
handpiece.
8. If the file tip goes | Same | |
| | an alarm will sound
and the backlight
will blink on an off. | and the backlight
will blink on an off. | past the Flash bar,
an alarm will sound
and the backlight
will blink on an off. | | |
| Comparison
Statement | The EQ-M
motorized
handpiece can be
used to enlarge
and prepare root
canals, remove
gutta-percha
points.
When connected to
Apex locator, the
EQ-M can be used
to measure the
length of root
canals. | The Tri Auto mini
motorized
handpiece can be
used to enlarge
and prepare root
canals, remove
gutta-percha
points, and for
professional tooth
cleaning. When
connected to Apex
locator, the Tri Auto
mini can be used to
measure the length
of root canals. | The Tri Auto ZX2
device is a cordless
endodontic
treatment
motorized
handpiece with root
canal measurement
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 for
measuring canal
length. | Same | |
| Principle of
operation | 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 (tip) to rotate
the file (tip). When
connected to Apex
Locator (EQ-PEX),
the EQ-M indicates
the position of the
file tip inside the
root canal. | The Tri Auto mini is
a Battery- driven
handpiece with a
motor, equipped
with the chuck for
holding rotary
instrument such as
a dental file and a
reamer. Tri Auto
mini can be used
for enlargement
and preparation of
root canals. When
connected to Apex
Locator, the Tri
Auto mini indicates
the position of the
file tip inside the
root canal. | Electrical motor
drives the rotating
of file equipped on
the rotating to
accomplish its
indication for use.
And the software
control the
parameter and
method of rotating. | Same | |
| Intended use | - Canal
enlargement
- Root canal length
measurement
(When connected
to Apex Locator) | - Canal
enlargement - Root canal length
measurement
(When connected
to Apex Locator) | - Canal
enlargement - Root canal length
measurement | Same | |
| Indication for
use | The EQ-M
motorized | The Tri Auto mini
motorized | The Tri Auto ZX2
device is a cordless | Same | |
| 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. | handpiece can be
used to enlarge
and prepare root
canals, remove
gutta-percha
points, and for
professional tooth
cleaning. When
connected to Apex
locator, the Tri Auto
mini can be used to
measure the length
of root canals. | endodontic
treatment
motorized
handpiece with root
canal measurement
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 for
measuring canal
length. | | | |
| 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 | The Tri Auto mini is
a battery- driven
handpiece with a
motor, equipped
with the chuck for
holding rotary
instrument such as
a dental file and a
reamer. Tri Auto
mini can be used
for enlargement
and preparation of
root canals. When
connected to Apex
Locator (Which is
not included in this
application), the Tri
Auto mini indicates
the position of the
file tip inside the
root canal. | The Tri Auto ZX2 is
a battery-driven
handpiece with a
motor, equipped
with a
chuck for holding
rotary instruments
such as a dental
file and reamer.
The
Tri Auto ZX2 can
be used for cutting
and grinding teeth
by transferring
rotary
movement to a
rotary instrument
attached to the
head. Cutting and
grinding of
teeth can be done
depending on the
situation by
switching
(reversing) the
rotation
direction. Rotation
speed is
accelerated or
decelerated
according to the
user's
preference, rotation
control based on
torque detection, or
set timing. These
controls enable the | Same | |
| | 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 an alarm will
beep and the text
apex will appear on
the measurement
screen. | | cutting, grinding,
enlargement, and
preparation of root
canals.
Moreover, the Tri
Auto ZX2 can be
used for the
removal of
extraneous
materials
such as gutta-
percha points, and
for professional
mechanical tooth
cleaning.
In addition, the Tri
Auto ZX2 can be
used as an apex
locator, and the
measured
value can be used
for rotation control. | | |
| Usage | Prescription Use | Prescription Use | Prescription Use | Same | |
| | | Technical Specification | | | |
| Energy used
and/or
delivered | Li-ion battery
(DC 3.7V) | Li-ion battery
(DC 3.7V) | Li-ion battery
(DC 3.7V) | Same | |
| Exterior
Design | 28 mm x 27.2 mm x
154.4mm
Charger: 80 mm x
83 mm x 89.5 mm | 18 mm x 18 mm x
165 mm
Charger: 85 mm x
108 mm x 68 mm | 30 mm x 30mm x
200 mm
Charger: 85 mm x
85mm x 75 mm | Different (1) | |
| Performance 1 - canal
enlargement | 100-1,000rpm,
4Ncm | 50-1,000rpm,
4Ncm | 100-1,000rpm,
4Ncm | Same | |
| Performance 2 - apex locator | Accuracy of the
root apex locator
function: -0.5mm to
+0.5mm from Apex
position | - | Accuracy of the
root apex
locator function : -
1.5mm to
+0.5mm for Apex
position. | Different (2) | |
| Setting Mode | EAL: When the
Apex Locator and
EQ-M are
connected properly.
CW: The motor
rotates clockwise.
CCW: The motor
rotates
counterclockwise.
RCP: The motor
alternates between
clockwise and
counterclockwise
rotation.
ART: The motor
rotates clockwise
while changing its
speed. | Linked function:
These functions are
available only when
connected to the
Electronic Apex
Locator.
Fwd: The motor
rotates clockwise.
Rev: The motor
rotates
counterclockwise.
Torque Reverse:
nine torque reverse
settings
Auto controls: Auto
torque Reverse/
Auto torque
slowdown | EMR Mode: This
mode is for canal
measurement.
CW Mode: The
motor rotates
clockwise.
OGP Mode:
Optimum Glide
Path function is
used for canal
negotiation and
making the glide
path. | Different (3) | |
| Display setting | 1.
Memory number
- EQ-M and Apex
Locator connection - Battery Power
- Motor operation
information
- CW: Rotation
Direction - RPM: Motor
Speed - Ncm: Torque
- STP: The motor
stops when it
reaches the set
torque limit. | 1.
Memory number
- Rotation
Direction - Battery Power
- Speed Setting
- Torque Reverse
Setting | 1. Memory Number - Battery Power
- Operation Mode
- Speed Setting
- Torque Limit
Setting | Same. | |
| Spray nozzle | Spray nozzle | - | Spray nozzle | Same | |
| Sterility | Contra angle
(Lip hook are not
attached) | Contra angle
(File holder and
Contrary electrode
are not attached) | File holder,
contrary electrode,
and contra angle
are autoclavable. | Same | |
| Applied Standards | | | | | |
| Standards met | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-6
IEC 62304
ISO 14971
ISO 10993-1
ISO 10993-5
ISO 10993-10
ISO 17665-1
ISO 17665-2 | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-4
IEC 60601-1-6
ISO 14971
ISO 10993-1
ISO 10993-5
ISO 10993-12
ISO 17664 | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-6
IEC 62304
IEC 62366
ISO 14971
ISO 10993-1
ISO 10993-5
ISO 10993-12
ISO 15223-1 | Different (4) | |
| | ISO 11737-1
IEC 62366-1
IEC 62133-2
IEC 80601-2-60
ISO 14457
ISO 1797-1
ISO 7405
ISO 15223-1 | | ISO 17664 | | |
| Materials | Materials
conform to ISO -
| Materials
conform to ISO
10993. | Materials
conform to ISO
10993. | Same | |
| Compatibility
with
environment
and other
devices. | Conform to IEC
60601-1-2 | Conform to IEC
60601-1-2 | Conform to IEC
60601-1-2 | Same | |
| Electrical
Safety | Conform to IEC
60601-1 | Conform to IEC
60601-1 | Conform to IEC
60601-1 | Same | |
| Mechanical
Safety | Conform to IEC
60601-1 | Conform to IEC
60601-1 | Conform to IEC
60601-1 | Same | |
| Thermal Safety | Conform to IEC
60601-1 | Conform to IEC
60601-1 | Conform to IEC
60601-1 | Same | |
| Radiation
safety | Conform to IEC
60601-1-2 | Conform to IEC
60601-1-2 | Conform to IEC
60601-1-2 | Same | |
5
6
7
8
9
Justifications for differences between proposed device and the predicate device are shown as below: Different (1): The exterior design of the EQ-M compared to the Tri Auto mini has slightly changed for design. However, the structures of both devices which include the contra angle that connects and rotates the files are substantially equivalent. Moreover, the principle of controlling the rotation by measurement result, load value, setting etc. is also substantially equivalent. The structure to which the probe code of the Apex locator is connected is also substantially equivalent.
Different (2): The accuracy of the root apex locator is within the accuracy of the Tri Auto ZX II reference predicate device, thus substantially the equivalent.
Different (3): The names of the modes are different, but the functions are substantially identical. Different (4): The standards applied to the EQ-M include those of predicate devices, so there is no effect on safety and effectiveness.
Non-Clinical Study performance
To be in compliance with electromagnetic safety and compatibility, appropriate study has been applied to the subject device in accordance with the following standard
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
|---|---|
| IEC 60601-1:2005 + A1:2012 | Medical electrical equipment - Part 1: General requirements |
| for basic safety and essential performance | |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part1-2: General |
| requirements for basic safety and essential performance – | |
| Collateral standard: Electromagnetic compatibility – | |
| Requirements and tests | |
| IEC 60601-1-6: 2010/AMD1:2013 | Medical electrical equipment - Part 1-6: General |
| requirements for safety and essential performance - | |
| Collateral standard: Usability | |
| IEC 62366-1:2015 | Medical devices - Part 1: Application of usability |
| engineering to medical devices | |
| IEC 62304:2006+A1:2015 | Medical device software - Software life cycle processes |
| IEC 62133-2:2017 | Secondary cells and batteries containing alkaline or other |
| non-acid electrolytes - Safety requirements for portable | |
| sealed secondary cells, and for batteries made from them, | |
| for use in portable applications | |
| ISO 15223-1:2021 | Medical devices - Symbols to be used with medical device |
| labels, labelling and information to be supplied - Part 1: | |
| General requirements | |
| ISO 7010:2019 | Graphical symbols - Safety colors and safety signs - |
| Registered safety signs | |
| ISO 10993-1:2018 | Biological evaluation of medical devices - Part 1: Evaluation |
| and testing within a risk management process | |
| ISO 10993-5:2009 | Biological evaluation of medical devices - Part 5: Test for in |
| vitro cytotoxicity | |
| ISO 10993-10:2010 | Biological evaluation of medical devices - Part 10: Tests for |
| irritation and skin sensitization | |
| ISO 11737-1:2018 | Sterilization of health care products - Microbiological |
| methods - Part 1: Determination of a population of | |
| microorganisms on products | |
| IEC 80601-2-60:2019 | Medical electrical equipment - Part 2-60: Particular |
| requirements for basic safety and essential performance of | |
| dental equipment | |
| ISO 14457:2017 | Dentistry - handpieces and motors |
| ISO 1797:2017 | Dentistry - Shanks for rotary and oscillating instruments |
| ISO 7405:2018 | Dentistry - Evaluation of biocompatibility of medical devices |
| used in dentistry | |
| FDA Reprocessing Guidance | Reprocessing Medical Devices in Health Care Settings: |
| Validation Methods and Labeling | |
| FDA Software Guidance | Guidance for the Content of Premarket Submissions for |
| Software Contained in Medical Devices |
10
Conclusion
Subject device has the same device characteristics as the predicate device, based on the information provided in this summary we conclude that subject device is substantially equivalent to the predicate device.