Tri Auto ZX2

K170275 · J. Morita USA, Inc. · EKX · Sep 11, 2017 · Dental

Device Facts

• Record ID: K170275
• Device Name: Tri Auto ZX2
• Applicant: J. Morita USA, Inc.
• Product Code: EKX · Dental
• Decision Date: Sep 11, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

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.

Device Story

Cordless, battery-operated endodontic handpiece; used by dentists in clinical settings. Input: rotary motion via dental file/reamer; electrical impedance signals for apex location. Operation: motor rotates file for canal enlargement/preparation; integrated apex locator monitors file tip position within canal. Output: mechanical rotation; visual/audible feedback of file position. Clinical utility: enables simultaneous canal enlargement and length monitoring; assists in removal of gutta-percha and mechanical tooth cleaning. Benefits: improved procedural efficiency and accuracy in root canal therapy.

Clinical Evidence

No clinical data. Substantial equivalence established via bench testing, including electrical safety, electromagnetic compatibility, usability, software validation, and performance testing for canal enlargement and apex location accuracy.

Technological Characteristics

Battery-powered (Li-ion 3.7V) handpiece; contra-angle attachment. Materials: Polyphenylsulfone (PPSU) and polypropylene (ISO 10993 compliant). Features: integrated apex locator, torque-controlled rotation, reversible rotation. Sterilization: autoclavable components (file holder, electrode, contra-angle). Standards: IEC 60601-1, IEC 60601-1-2, IEC 62304, ISO 14971, ISO 14457.

Indications for Use

Indicated for patients age 12 and older requiring endodontic treatment, specifically for root canal enlargement and canal length measurement.

Regulatory Classification

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.

Predicate Devices

• Tri Auto ZX (K970339)

Reference Devices

• Tri Auto Mini (K112665)
• DENTAPORT ZX (K031204)
• Root ZX (K953867)
• Root ZX (K921979)
• Root ZX Mini (K090925)

Submission Summary (Full Text)

{0}------------------------------------------------

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.

{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 (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 [phone] or [phone] 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 [phone] or [phone] 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

{2}------------------------------------------------

# 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)

{3}------------------------------------------------

# 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: [phone] 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: [phone] Facsimile: [phone] Email: [e-mail]

#### (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

{4}------------------------------------------------

## 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<br>motorized handpiece with root canal measurement capability. It<br>can be used to enlarge canals while monitoring the position of the<br>file tip inside the canal. It can be used as a low-speed motorized<br>handpiece and device for measuring canal length. |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K#970339 primary<br>predicate | The Tri Auto-ZX device is a cordless endodontic treatment<br>motorized handpiece with root canal measurement capability. It<br>can be used to enlarge canals while monitoring the position of the<br>file tip inside the canal. It can be used to measure the length of<br>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<br>and prepare root canals, remove gutta-percha points, and for<br>professional tooth cleaning. When connected to Apex locator,<br>the Tri Auto mini can be used to measure the length of root<br>canals. |
| K#031204 | The DENTAPORT ZX is a dental root canal measurement and<br>treatment device that can measure the length of the root canal and<br>enlarge the canal while monitoring the position of the file tip<br>inside the canal. |
| K#090925 | RCM-7 is a dental device, Apex Locator. It can be used to detect<br>the apex of root canal. |
| K#921979 | Cleared prior to requirement for formal Indications for Use<br>statements |
| K#953867 | Cleared prior to requirement for formal Indications for Use<br>statements |

{5}------------------------------------------------

#### 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.

{6}------------------------------------------------

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<br>TR-ZX2 | Tri Auto ZX<br>TR-ZX | Tri Auto mini<br>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<br>Root canal<br>length<br>measurement | Canal enlargement<br>Root canal length<br>measurement | Canal enlargement<br>Root canal length<br>measurement(When connected<br>to Apex locator) | Intended use of Tri Auto ZX2 is<br>the same as that of the primary<br>predicate, Tri Auto ZX |
| Indications for use | The Tri Auto ZX2 device is a<br>cordless endodontic<br>treatment motorized<br>handpiece with root canal<br>measurement capability. It<br>can be used to enlarge canals<br>while monitoring the position<br>of the file tip inside the<br>canal. It can be used as a<br>low-speed motorized<br>handpiece and device for<br>measuring canal length. | The TRI AUTO ZX device is a<br>cordless endodontic treatment<br>motorized handpiece with root<br>canal measurement capability.<br>It can be used to enlarge canals<br>while monitoring the position of the file tip inside the canal.<br>It can be used to measure the<br>length of the canal, and it can<br>be used as a low speed<br>motorized handpiece. | The Tri Auto mini motorized<br>handpiece can be used to<br>enlarge and prepare root canals,<br>remove gutta- percha points,<br>and for professional tooth<br>cleaning. When connected to<br>Apex locator, the Tri Auto mini<br>can be used to measure the<br>length of root canals. | The Tri Auto ZX2 and Tri<br>Auto ZX Indications for Use<br>are nearly identical and the<br>small difference in wording is<br>not significant.<br>The Tri Auto mini is a root<br>canal enlargement device<br>without the root canal<br>measurement function.<br>However, the Tri Auto mini can<br>be connected to the apex<br>locator, and it can have the<br>same function as Tri Auto ZX2<br>by connecting with the Apex<br>locator. |
| Target population | Patient population is age 12<br>and older | All patients in dentistry | All patients in dentistry | Target population in the Tri Auto<br>ZX2 is included in that of the<br>predicate devices, thus, this<br>difference has no influence on<br>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<br>hospital and the other<br>clinical settings | Dental clinic, University<br>hospital and the other<br>clinical settings | Dental clinic, University<br>hospital and the other<br>clinical settings | Identical to predicate devices. |
| Energy used and/or<br>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<br>the Tri Auto mini. |
| | Product name | Primary predicate | Reference predicate | Similarities/Differences |
| Model | Tri Auto ZX2<br>TR-ZX2 | Tri Auto ZX<br>TR-ZX | Tri Auto mini<br>TR-CM | - |
| Design | 30 mm x 30mm x 200 mm<br>Charger: 85 mm x 85mm x<br>75 mm | 30 mm x 37 mm x 55 mm<br>Charger: 80 mm x 123 mm<br>x 55 mm | 18 mm x 18 mm x 165 mm<br>Charger: 85 mm x 108 mm<br>x 68 mm | The exterior design of the Tri<br>Auto ZX2 compared to the<br>Tri Auto ZX has slightly<br>changed for design<br>improvement. However, the<br>structures of both devices<br>which include the contra<br>angle that connects and<br>rotates the files, the probe for<br>measuring the root canal<br>length, and the built-in root<br>canal length measurement<br>function are substantially<br>equivalent. Moreover, the<br>principle of controlling the<br>rotation by measurement<br>result, load value, setting etc.<br>is also substantially<br>equivalent. |
| Performance 1 -<br>canal enlargement | 100-1,000rpm, 4Ncm (min.) | 280rpm, 4.5Ncm (min.) | 50-1,000rpm, 4Ncm (min.) | The rotation speed of Tri Auto ZX2<br>is within the speed of the Tri Auto<br>mini reference predicate device,<br>thus substantially equivalent. |
| Performance 2 -<br>apex locator | Accuracy of the root apex<br>locator function : -1.5mm to<br>+0.5mm for Apex position. | Accuracy of the root apex<br>locator function : -1.5mm to<br>+0.5mm for Apex position. | | The principle of the root canal<br>length measurement function of<br>the Tri Auto ZX2 is the same as<br>the reference predicates<br>manufactured by J. Morita (the Tri<br>Auto ZX, DENTAPORT ZX, Root<br>ZX and Root ZX mini). The<br>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<br>Nozzle | | The spray nozzle of Tri Auto ZX2<br>has a different shape (connection<br>diameter is different), but its use<br>and material are the same as for<br>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<br>environment and<br>other devices | | | | |
| | File holder, contrary<br>electrode, and contra Angle<br>are autoclavable. | File holder, contrary electrode,<br>and contra Angle are<br>autoclavable. | Contra Angle are<br>autoclavable.<br>(File holder and Contrary<br>electrode are not attached) | Sterility is the same as that of Tri<br>Auto ZX and there is no difference<br>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<br>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…