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 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.

AI/ML Overview

The provided text is a 510(k) Summary for the Tri Auto ZX2, a dental device. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a standalone study with defined ground truth. Therefore, much of the requested information regarding acceptance criteria, sample size for test sets, expert involvement, and ground truth establishment is not directly applicable or available in this type of document.

However, I can extract the information that is present and indicate where the requested details are not provided.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for the Tri Auto ZX2 as performance metrics to be proven against in a standalone study. Instead, it compares the device's technological characteristics to predicate devices to demonstrate substantial equivalence. The "performance" section within the comparison table implicitly serves as a form of performance criteria.

Feature	Acceptance Criteria (Implied from Predicate Comparison)	Reported Device Performance (Tri Auto ZX2)
Canal Enlargement Performance	Rotation speed and torque comparable to predicate devices (Tri Auto ZX: 280rpm, 4.5Ncm (min.); Tri Auto mini: 50-1,000rpm, 4Ncm (min.)).	Engine Performance: 100-1,000rpm, 4Ncm (min.).
Apex Locator Accuracy	Accuracy of the root apex locator function: -1.5mm to +0.5mm for Apex position (same as Tri Auto ZX).	Accuracy of the root apex locator function: -1.5mm to +0.5mm for Apex position.
Materials	Used materials conform to ISO10993.	Used materials conform to ISO10993.
Sterility	Autoclavability of file holder, contrary electrode, and contra angle (same as Tri Auto ZX).	File holder, contrary electrode, and contra Angle are autoclavable.
Electrical Safety	Conform to IEC60601-1.	Conform to IEC60601-1.
Electromagnetic Compatibility	Conform to IEC60601-1-2.	Conform to IEC60601-1-2.
Usability	Conform to IEC 60601-1-6 and IEC 62366.	Conform to IEC 60601-1-6 and IEC 62366.
Software	Conform to IEC 62304.	Conform to IEC 62304.
Risk Management	Conform to ISO 14971.	Conform to ISO 14971.
Biological Evaluation	Conform to ISO 10993-1, ISO 10993-5 (cytotoxicity), ISO 10993-12 (sample preparation). Materials used in contra angle (polyphenylsulfone (PPSU)) and disposable cover (polypropylene) pass biocompatibility testing.	Conform to ISO 10993-1, ISO 10993-5, ISO 10993-12. Biocompatibility testing conducted for PPSU and polypropylene.
Sterilization	Conform to ISO 17664, ISO 17665-1, ISO 17665-2.	Conform to ISO 17664, ISO 17665-1, ISO 17665-2.
Handpiece Standards	Conform to ISO 14457.	Conform to ISO 14457.

2. Sample size used for the test set and the data provenance

The document states, "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." However, it does not specify the sample size for this performance testing, nor does it provide details on the data provenance (e.g., country of origin of the data, retrospective or prospective). This would typically be found in a detailed study report, not a 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the 510(k) summary. Given that testing was for technical functions like rotation speed, torque, and apex locator accuracy, it is likely that engineering measurements and established reference methods were used rather than expert human assessment for ground truth.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided and is generally not applicable to the type of in-vitro, engineering-focused performance testing described for this device. Adjudication methods are more common in clinical studies where human interpretation of results is involved.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

The Tri Auto ZX2 is a physical dental handpiece with an integrated apex locator, not an AI-powered diagnostic imaging device. Therefore, an MRMC comparative effectiveness study is not applicable to this device, and no such study was performed or reported.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document mentions "Performance testing was conducted to confirm that the device is capable of measuring and enlarging root canals..." This implies standalone performance testing of the device's functions. However, it's not an "algorithm only" device in the context of AI, but rather a physical instrument. The "algorithm" for apex location is embedded. The results of this testing led to the claims of achieving the "Accuracy of the root apex locator function: -1.5mm to +0.5mm for Apex position" and the specified engine performance. Details of the methodology and results would be in the full test reports, not the summary.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The formal "ground truth" as typically defined for diagnostic AI is not explicitly stated for the performance testing. For the apex locator function, ground truth would likely be established through physical measurements against known lengths in standardized root canal models or extracted teeth, using precise tools, and for the motor, it would be direct engineering measurements of RPM and torque. This is based on the nature of the device's functions, which are quantifiable physical properties rather than subjective interpretations.

8. The sample size for the training set

The device is a physical instrument with embedded control logic (not a machine learning AI), therefore, the concept of a "training set" in the context of AI development does not apply. The device's control system and apex locator function are based on established engineering principles and algorithms, likely developed through R&D and traditional software engineering, not machine learning training.

9. How the ground truth for the training set was established

As the concept of a "training set" for AI does not apply to this device artifact, the establishment of ground truth for a training set is not applicable.

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:

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)

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 treatmentmotorized handpiece with root canal measurement capability. Itcan be used to enlarge canals while monitoring the position of thefile tip inside the canal. It can be used as a low-speed motorizedhandpiece and device for measuring canal length.
K#970339 primarypredicate	The Tri Auto-ZX device is a cordless endodontic treatmentmotorized handpiece with root canal measurement capability. Itcan be used to enlarge canals while monitoring the position of thefile tip inside the canal. It can be used to measure the length ofthe canal, and it can be used as a low-speed motorized handpiece.
K#112665	The Tri Auto mini motorized handpiece can be used to enlargeand prepare root canals, remove gutta-percha points, and forprofessional tooth cleaning. When connected to Apex locator,the Tri Auto mini can be used to measure the length of rootcanals.
K#031204	The DENTAPORT ZX is a dental root canal measurement andtreatment device that can measure the length of the root canal andenlarge the canal while monitoring the position of the file tipinside the canal.
K#090925	RCM-7 is a dental device, Apex Locator. It can be used to detectthe apex of root canal.
K#921979	Cleared prior to requirement for formal Indications for Usestatements
K#953867	Cleared prior to requirement for formal Indications for Usestatements

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807.92(a)(4): Device Description

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 ZX2TR-ZX2	Tri Auto ZXTR-ZX	Tri Auto miniTR-CM
Manufacturer	J. MORITA MFG. CORP.	J. MORITA MFG. CORP.	J.MORITA MFG.CORP	Identical
510(k) Number		K970339	K112665
Intended use	Canal enlargementRoot canallengthmeasurement	Canal enlargementRoot canal lengthmeasurement	Canal enlargementRoot canal lengthmeasurement(When connectedto Apex locator)	Intended use of Tri Auto ZX2 isthe same as that of the primarypredicate, Tri Auto ZX
Indications for use	The Tri Auto ZX2 device is acordless endodontictreatment motorizedhandpiece with root canalmeasurement capability. Itcan be used to enlarge canalswhile monitoring the positionof the file tip inside thecanal. It can be used as alow-speed motorizedhandpiece and device formeasuring canal length.	The TRI AUTO ZX device is acordless endodontic treatmentmotorized handpiece with rootcanal measurement capability.It can be used to enlarge canalswhile monitoring the position of the file tip inside the canal.It can be used to measure thelength of the canal, and it canbe used as a low speedmotorized handpiece.	The Tri Auto mini motorizedhandpiece can be used toenlarge and prepare root canals,remove gutta- percha points,and for professional toothcleaning. When connected toApex locator, the Tri Auto minican be used to measure thelength of root canals.	The Tri Auto ZX2 and TriAuto ZX Indications for Useare nearly identical and thesmall difference in wording isnot significant.The Tri Auto mini is a rootcanal enlargement devicewithout the root canalmeasurement function.However, the Tri Auto mini canbe connected to the apexlocator, and it can have thesame function as Tri Auto ZX2by connecting with the Apexlocator.
Target population	Patient population is age 12and older	All patients in dentistry	All patients in dentistry	Target population in the Tri AutoZX2 is included in that of thepredicate devices, thus, thisdifference has no influence onsafety and effectiveness.
Anatomical sites	Root canal, softened dentin	Root canal, softened dentin	Root canal, softened dentin	Identical to predicate devices.
Where used	Dental clinic, Universityhospital and the otherclinical settings	Dental clinic, Universityhospital and the otherclinical settings	Dental clinic, Universityhospital and the otherclinical settings	Identical to predicate devices.
Energy used and/ordelivered	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 ofthe Tri Auto mini.
	Product name	Primary predicate	Reference predicate	Similarities/Differences
Model	Tri Auto ZX2TR-ZX2	Tri Auto ZXTR-ZX	Tri Auto miniTR-CM	-
Design	30 mm x 30mm x 200 mmCharger: 85 mm x 85mm x75 mm	30 mm x 37 mm x 55 mmCharger: 80 mm x 123 mmx 55 mm	18 mm x 18 mm x 165 mmCharger: 85 mm x 108 mmx 68 mm	The exterior design of the TriAuto ZX2 compared to theTri Auto ZX has slightlychanged for designimprovement. However, thestructures of both deviceswhich include the contraangle that connects androtates the files, the probe formeasuring the root canallength, and the built-in rootcanal length measurementfunction are substantiallyequivalent. Moreover, theprinciple of controlling therotation by measurementresult, load value, setting etc.is also substantiallyequivalent.
Performance 1 -canal enlargement	100-1,000rpm, 4Ncm (min.)	280rpm, 4.5Ncm (min.)	50-1,000rpm, 4Ncm (min.)	The rotation speed of Tri Auto ZX2is within the speed of the Tri Automini reference predicate device,thus substantially equivalent.
Performance 2 -apex locator	Accuracy of the root apexlocator function : -1.5mm to+0.5mm for Apex position.	Accuracy of the root apexlocator function : -1.5mm to+0.5mm for Apex position.		The principle of the root canallength measurement function ofthe Tri Auto ZX2 is the same asthe reference predicatesmanufactured by J. Morita (the TriAuto ZX, DENTAPORT ZX, RootZX and Root ZX mini). Theaccuracy 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 SprayNozzle		The spray nozzle of Tri Auto ZX2has a different shape (connectiondiameter is different), but its useand material are the same as forthe 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 withenvironment andother devices
	File holder, contraryelectrode, and contra Angleare autoclavable.	File holder, contrary electrode,and contra Angle areautoclavable.	Contra Angle areautoclavable.(File holder and Contraryelectrode are not attached)	Sterility is the same as that of TriAuto ZX and there is no differencein the safety and effectiveness.
Sterility
Electrical safety	Conform to IEC60601-1	Conform to IEC60601-1	Conform to IEC60601-1	Identical to predicate devices.

Mechanicalsafety	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.

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.