TRI AUTO ZX

K970339 · J. Morita USA, Inc. · EKX · Jun 4, 1997 · Dental

Device Facts

• Record ID: K970339
• Device Name: TRI AUTO ZX
• Applicant: J. Morita USA, Inc.
• Product Code: EKX · Dental
• Decision Date: Jun 4, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

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.

Device Story

Tri Auto ZX is a cordless, battery-operated endodontic handpiece combining a motorized file driver with an electronic apex locator. Used by dentists during root canal therapy; device monitors file tip position within the canal while simultaneously performing mechanical canal enlargement. Input consists of electrical impedance signals measured between the file and an oral mucosal electrode; these signals are processed to determine file depth. Output is provided via visual indicators on the handpiece, allowing the clinician to track file position in real-time. This integration enables precise canal instrumentation, reducing risk of over-instrumentation and improving procedural efficiency.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and comparison of technological characteristics to existing endodontic instrumentation and measurement devices.

Technological Characteristics

Cordless, battery-powered motorized handpiece. Integrates electronic apex locator circuitry for impedance-based canal length measurement. Form factor is a handheld dental instrument. Sterilization via standard dental office protocols for reusable components.

Indications for Use

Indicated for use by dental professionals for endodontic procedures, specifically for enlarging root canals and monitoring file tip position during canal length measurement and instrumentation.

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUN - 4 1997

Mr. Terry G. Mahn
Fish & Richardson P.C.
C/O Fish & Richardson P.C.
601 Thirteenth Street, N.W.
Washington, DC 20005

Re: K970339
Trade Name: Tri Auto ZX
Regulatory Class: I
Product Code: EKX
Dated: May 21, 1997
Received: May 22, 1997

Dear Mr. Mahn:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Mahn

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone].

Sincerely yours,

Timothy A. Ulatowski
Director
Division of Dental, Infection Control and General Hospital Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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Page 4 of 4

510(k) Number (if known): K970339
Device Name: TRI AUTO ZX
Indications For Use:

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.

(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 Dental, Infection Control, and General Hospital Devices
510(k) Number K970339

Prescription Use ☐
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐

(Optional Format 1-2-96)