Predicate Devices

K#970339

Reference Devices

K#112665, K#031204, K#090925, K#921979, K#953867

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical and electrical controls based on torque detection and measured values from the apex locator, without mentioning any AI/ML algorithms or training/test data.

Therapeutic

Yes
The device is used for enlarging canals, cutting/grinding teeth, and professional mechanical tooth cleaning, which are therapeutic interventions aimed at treating dental conditions.

Diagnostic

Yes

The device measures canal length and provides a measured value that can be used for rotation control, functioning as an apex locator. Measuring canal length is a diagnostic function.

SaMD (Software as a Medical Device)

No

The device description explicitly details a battery-driven handpiece with a motor, chuck, and capabilities for physical actions like cutting, grinding, and transferring rotary movement. This indicates a significant hardware component beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, the Tri Auto ZX2 device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs are used to examine specimens derived from the human body. The Tri Auto ZX2 is a device used directly on the patient's teeth and root canals for mechanical procedures (enlarging canals, cutting, grinding, removing materials) and for measuring canal length in vivo.
The intended use and device description clearly outline its function as a dental handpiece and apex locator used during endodontic treatment. These are procedures performed directly on the patient.
There is no mention of analyzing biological samples or specimens.

Therefore, the Tri Auto ZX2 falls under the category of a dental device used for treatment and measurement within the patient's mouth, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

EKX, LQY

Device Description

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 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.

The Tri Auto ZX2 is intended to be sterilized prior to use.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Root canal, softened dentin

Indicated Patient Age Range

Patient population is age 12 and older

Intended User / Care Setting

Dental clinic, University hospital and the other clinical settings

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance testing was conducted to confirm that the device is capable of measuring and enlarging root canals in a manner that is substantially equivalent to the primary predicate and reference predicate devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Accuracy of the root apex locator function : -1.5mm to +0.5mm for Apex position.

Predicate Device(s)

K#970339

Reference Device(s)

K#112665, K#031204, K#090925, K#921979, K#953867

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, with a triple-line design representing the bodies.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 11, 2017

J. Morita USA, Inc. % Keith A. Barritt Attornev Fish & Richardson P.C. 901 15th Street, N.W., Suite 700 Washington, District of Columbia 20005

Re: K170275

Trade/Device Name: Tri Auto ZX2 Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Class I Product Code: EKX, LQY Dated: July 27, 2017 Received: July 28, 2017

Dear Keith A. Barritt:

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. 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.

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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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Andrew I. Steen -S

for Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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Indications for Use Statement

510(K) Number : K170275

Tri Auto ZX2. Device Name:

Indications for Use:

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.

Prescription Use) AND/OR (Part21CFR801 Subpart D)

Over-The-Counter Use (Part21CFR807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED Concurrence of CDRH, Office of Device Evaluation(ODE)

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(K) Number :

Prescription Use _ X (Part21CFR801.109)

or

Over-The-Counter Use (Optional Format 1-2-96)

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510(k) Summary J. Morita USA Inc. Tri Auto ZX2 Endodontic Treatment Motorized Handpiece

The following information is provided pursuant to 21 CFR 807.92.

807.92(a)(1): Submitter's Name/Address, Contact, and Preparation Date

(i) 510(k) Submitter

J. Morita USA, Inc. 9 Mason Irvine, CA 92618 Phone: (949) 581-9600 FDA Reg. No .: 2081055

(ii) 510(k) Submitter Contact

Keith A. Barritt Fish & Richardson P.C. 901 15th Street, N.W., Suite 700 Washington, DC 20005 Phone: (202) 783-5070 Facsimile: (202) 783-2331 Email: barritt@fr.com

(iii) Preparation Date

September 11, 2017

807.92(a)(2): Name of Device

Trade or Proprietary Name: Model Name: Common Name:

Classification Name: Primary Product Code: Secondary Product Code: Regulation:

Tri Auto ZX2 TR-ZX2 endodontic treatment motorized handpiece/ root canal apex locator dental handpiece and accessories EKX LOY 21 CFR 872.4200

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807.92(a)(3): Predicate Devices

The Tri Auto ZX2 (also referred to by its model number TR-ZX2) is substantially equivalent for purposes of FDA medical device regulations to various predicates. The primary predicate device is J. Morita's own Tri Auto ZX (K#970339). J. Morita's own Tri Auto Mini (K#112665) is a reference predicate for the function of enlarging root canals in particular. J. Morita's own DENTAPORT ZX (K#031204) and J. Morita's own Root ZX (K#953867 and K#921979) are reference predicates for the function of root canal measurement in particular. J. Morita's own Tri Auto Mini (K#112665), Root ZX Mini (K#090925), and DENTAPORT ZX (K#031204) are reference predicates for biocompatibility.

The Indications for Use statements for the subject device, primary predicate, and reference predicate devices (where applicable) appear below:

| Subject Device | 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. |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K#970339 primary
predicate | The Tri Auto-ZX 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 to measure the length of
the canal, and it can be used as a low-speed motorized handpiece. |
| K#112665 | 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. |
| K#031204 | The DENTAPORT ZX is a dental root canal measurement and
treatment device that can measure the length of the root canal and
enlarge the canal while monitoring the position of the file tip
inside the canal. |
| K#090925 | RCM-7 is a dental device, Apex Locator. It can be used to detect
the apex of root canal. |
| K#921979 | Cleared prior to requirement for formal Indications for Use
statements |
| K#953867 | Cleared prior to requirement for formal Indications for Use
statements |

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807.92(a)(4): Device Description

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 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.

The Tri Auto ZX2 is intended to be sterilized prior to use.

807.92(a)(5): Indication for Use

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 lowspeed motorized handpiece and device for measuring canal length.

807.92(a)(6): Technological Characteristics

The Tri Auto ZX2 device utilizes the same materials as predicate devices and the same energy source as the Tri Auto mini reference predicate device. The design is slightly different than the primary predicate device, as the Tri Auto ZX2 device is a larger sized device, but the basic design principles are the same.

The Tri Auto ZX3 device is substantially equivalent to the declared predicate devices. As noted above, the Indications for Use of TR-ZX2 device is nearly verbatim identical to the Indications for Use for the primary predicate.

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A comparison table of the technological characteristics of the Tri Auto ZX2 and the predicate devices appears below:

	Product name	Primary predicate	Reference predicate	Similarities/Differences
Model	Tri Auto ZX2
TR-ZX2	Tri Auto ZX
TR-ZX	Tri Auto mini
TR-CM
Manufacturer	J. MORITA MFG. CORP.	J. MORITA MFG. CORP.	J.MORITA MFG.CORP	Identical
510(k) Number		K970339	K112665
Intended use	Canal enlargement
Root canal
length
measurement	Canal enlargement
Root canal length
measurement	Canal enlargement
Root canal length
measurement(When connected
to Apex locator)	Intended use of Tri Auto ZX2 is
the same as that of the primary
predicate, Tri Auto ZX
Indications for use	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.	The TRI AUTO ZX 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 to measure the
length of the canal, and it can
be used as a low speed
motorized handpiece.	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 and Tri
Auto ZX Indications for Use
are nearly identical and the
small difference in wording is
not significant.
The Tri Auto mini is a root
canal enlargement device
without the root canal
measurement function.
However, the Tri Auto mini can
be connected to the apex
locator, and it can have the
same function as Tri Auto ZX2
by connecting with the Apex
locator.
Target population	Patient population is age 12
and older	All patients in dentistry	All patients in dentistry	Target population in the Tri Auto
ZX2 is included in that of the
predicate devices, thus, this
difference has no influence on
safety and effectiveness.
Anatomical sites	Root canal, softened dentin	Root canal, softened dentin	Root canal, softened dentin	Identical to predicate devices.
Where used	Dental clinic, University
hospital and the other
clinical settings	Dental clinic, University
hospital and the other
clinical settings	Dental clinic, University
hospital and the other
clinical settings	Identical to predicate devices.
Energy used and/or
delivered	Li-ion battery (DC 3.7V)	Ni-MH battery (DC 3.6V)	Li-ion battery (DC 3.7V)	Energy used is the same as that of
the Tri Auto mini.
	Product name	Primary predicate	Reference predicate	Similarities/Differences
Model	Tri Auto ZX2
TR-ZX2	Tri Auto ZX
TR-ZX	Tri Auto mini
TR-CM	-
Design	30 mm x 30mm x 200 mm
Charger: 85 mm x 85mm x
75 mm	30 mm x 37 mm x 55 mm
Charger: 80 mm x 123 mm
x 55 mm	18 mm x 18 mm x 165 mm
Charger: 85 mm x 108 mm
x 68 mm	The exterior design of the Tri
Auto ZX2 compared to the
Tri Auto ZX has slightly
changed for design
improvement. However, the
structures of both devices
which include the contra
angle that connects and
rotates the files, the probe for
measuring the root canal
length, and the built-in root
canal length measurement
function are substantially
equivalent. Moreover, the
principle of controlling the
rotation by measurement
result, load value, setting etc.
is also substantially
equivalent.
Performance 1 -
canal enlargement	100-1,000rpm, 4Ncm (min.)	280rpm, 4.5Ncm (min.)	50-1,000rpm, 4Ncm (min.)	The rotation speed of Tri Auto ZX2
is within the speed of the Tri Auto
mini reference predicate device,
thus substantially equivalent.
Performance 2 -
apex locator	Accuracy of the root apex
locator function : -1.5mm to
+0.5mm for Apex position.	Accuracy of the root apex
locator function : -1.5mm to
+0.5mm for Apex position.		The principle of the root canal
length measurement function of
the Tri Auto ZX2 is the same as
the reference predicates
manufactured by J. Morita (the Tri
Auto ZX, DENTAPORT ZX, Root
ZX and Root ZX mini). The
accuracy is substantially the same.
Product name	Model	Primary predicate	Reference predicate	Similarities/Differences
	Tri Auto ZX2	Tri Auto ZX	Tri Auto mini
	TR-ZX2	TR-ZX	TR-CM
	IEC 60601-1	IEC 60601-1	IEC 60601-1	The standards applied to the
	IEC 60601-1-2	IEC 60601-1-2	IEC 60601-1-2	Tri Auto ZX2 include those of
	IEC 60601-1-6	IEC 60601-1-4	IEC 60601-1-4	predicate devices, so there is no
	IEC 62304	IEC 60601-1-6	IEC 60601-1-6	effect on safety and
	IEC 62366	ISO 14971	ISO 14971	effectiveness.
Standards met	ISO 14971	ISO 10993-1	ISO 10993-1
	ISO 10993-1	ISO 10993-5	ISO 10993-5	* IEC62304 and IEC62366
	ISO 10993-5	ISO 10993-12	ISO 10993-12	are standards set after the
	ISO 10993-12	ISO 17664	ISO 17664	clearance of Tri Auto ZX.
	ISO 15223-1
	ISO 17664
	Used materials conform to	Used materials conform to	Used materials conform to	Identical to predicate devices.
Materials	ISO10993.	ISO10993.	ISO10993.
	Spray nozzle	Tri Auto ZX AR Spray
Nozzle		The spray nozzle of Tri Auto ZX2
has a different shape (connection
diameter is different), but its use
and material are the same as for
the Tri Auto ZX.
Spray nozzle
	Conform to IEC60601-1-2	Conform to IEC60601-1-2	Conform to IEC60601-1-2	Identical to predicate devices.
Compatibility with
environment and
other devices
	File holder, contrary
electrode, and contra Angle
are autoclavable.	File holder, contrary electrode,
and contra Angle are
autoclavable.	Contra Angle are
autoclavable.
(File holder and Contrary
electrode are not attached)	Sterility is the same as that of Tri
Auto ZX and there is no difference
in the safety and effectiveness.
Sterility
Electrical safety	Conform to IEC60601-1	Conform to IEC60601-1	Conform to IEC60601-1	Identical to predicate devices.

Mechanical
safety	Conform to IEC60601-1	Conform to IEC60601-1	Conform to IEC60601-1	Identical to predicate devices.
Thermal safety	Conform to IEC60601-1	Conform to IEC60601-1	Conform to IEC60601-1	Identical to predicate devices.

Radiation safety	Conform to IEC60601-1-2	Conform to IEC60601-1-2	Conform to IEC60601-1-2	Identical to predicate devices.

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807.92(b)(1): Non-clinical Testing

The Tri Auto ZX2 was tested for compliance and/or developed in accordance with the following international standards, including validation of the reprocessing instructions pursuant to FDA's guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling: Guidance for Industry and Food and Drug Administration Staff":

IEC 60601-1 Ed.3.1:2012 Medical Electronic Equipment

This testing is designed to ensure the electrical safety of the device.

IEC 60601-1-2:2007 Electromagnetic Compatibility

This testing is designed to ensure the electromagnetic compatibility of the device when operated in its expected use environment.

IEC 60601-1-6:2010+A1:2013 Usability

This testing is designed to ensure reasonable device usability to minimize use errors and use-associated risks.

IEC 62304:2006 Medical Device Software

This testing is designed to ensure the software fulfils its intended purpose without causing any unacceptable risks.

IEC 62366 Ed.1.1 2014 Medical Devices - Application of Usability Engineering

This testing is designed to analyze, specify, design, verify and validate usability as it relates to safety of a medical device. This usability engineering process assesses and mitigates risks caused by usability problems associated with correct use and use errors, i.e. normal use.

ISO 14971: 2007 Application of Risk Management to Medical Devices

This standard provides a framework for systematically managing the risks associated with the use of medical devices. It addresses processes for managing risks, primarily to the patient, but also to the operator, other persons, other equipment, and the environment.

ISO 10993-1:2009/AC2010 Biological Evaluation of Medical Devices

This testing is designed to address the biological evaluation of medical devices within a risk management process.

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ISO 10993-5: 2009 Biological Evaluation: Test for In Vitro Cytotoxicity

This testing is designed to assess the in vitro cytotoxicity of medical devices and to determine the biological response of mammalian cells in vitro using appropriate biological parameters.

ISO 10993-12:2012 Biological Evaluation: Sample Preparation and Reference Materials

This standard specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems.

ISO 15223-1:2012 Medical Devices – Symbols Used with Medical Device Labels

This standard identifies requirements for symbols used in medical device labelling that convey information on the safe and effective use of medical devices.

ISO 17664:2004 Sterilization of Medical Devices
ISO 17665-1: 2006 Sterilization of Health Care Products
ISO 17665-2: 2009 Sterilization of Health Care Products

This standard specifies the information to be provided by a medical device manufacturer on the processing of medical devices claimed to be resterilizable, and medical devices intended to be sterilized by the processor, so that the medical device can be processed safely and will continue to meet its performance specification. The sterility assurance level for each sterilization method was 10°.

ISO 14457:2012 Dentistry - Handpieces and motors

This standard is applicable to handpieces and motors used in dentistry for patient contact, regardless of their construction. It specifies requirements, test methods, manufacturer's information, marking and packaging.

Performance testing was conducted to confirm that the device is capable of measuring and enlarging root canals in a manner that is substantially equivalent to the primary predicate and reference predicate devices.

Biocompatibility testing was conducted for certain materials, namely, the polyphenylsulfone (PPSU) used in the contra angle and the polypropylene used for the disposable cover.

In summary, the non-clinical testing establishes that the device is substantially equivalent.

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807.92(b)(2): Clinical Testing

There were no clinical tests performed for the Tri Auto ZX2 device.

807.92(b)(3): Conclusions from Testing

Based on the comparison of the Tri Auto ZX2 device to the primary predicate device and reference predicates identified above, and based on the data gathered in the non-clinical testing described above, it is concluded that the data provided in this 510(k) submission demonstrates that the Tri Auto ZX2 device is substantially equivalent to the predicate devices.