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.

Device Description

The DENTAPORT ZX is a low-voltage electric motor and root canal length measuring device.

AI/ML Overview

This 510(k) submission (K031204) for the DENTAPORT ZX Dental Device is a Special 510(k) and focuses solely on a change in sterilization instructions. Therefore, it does not include a study demonstrating the device's performance against acceptance criteria. The submission states directly: "The DENTAPORT ZX covered by this submission is identical in every respect to the DENTAPORT device already authorized by the FDA under K#022147. The only difference is a change in the instructions for use regarding the sterilization of the device."

The approval is based on the substantial equivalence to the predicate device (K#022147) and the validation of the new sterilization parameters.
As such, most of the requested information regarding performance studies is not applicable to this specific 510(k) submission.

Here's a breakdown of what can and cannot be provided from the given document:

1. Table of acceptance criteria and reported device performance:

Not applicable for this 510(k). This submission is for a change in sterilization procedures, not a de novo device or a significant performance modification requiring new clinical or bench performance data for the primary function of root canal measurement. The performance of the device's primary function is assumed to be equivalent to the predicate (K#022147).

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

Not applicable for primary device performance. The only "test" mentioned relates to sterilization validation, not the accuracy of root canal length measurement. For sterilization studies, sample sizes would typically relate to the number of sterilization cycles and biological indicators/test articles, but this information is not detailed in the provided summary.

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

Not applicable. No clinical or performance test set, in the context of root canal measurement accuracy, is described in this submission.

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

Not applicable. No clinical or performance test set is described.

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

Not applicable. This device is a measurement and treatment device, not an AI-assisted diagnostic tool.

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

Not applicable. This device is hardware and does not describe an algorithm for standalone performance. Its function relies on human operation.

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

Not applicable for root canal measurement accuracy. For sterilization validation, the "ground truth" would be the successful killing of microorganisms to achieve a sterility assurance level (SAL) of 10^-6, verified typically by biological indicator testing, but this is not detailed here beyond the statement that it was validated.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device requiring a training set.

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

Not applicable. This is not an AI/machine learning device.

In summary, this 510(k) submission (K031204) is a limited submission for a change in sterilization instructions for an already cleared device, not a submission introducing new performance claims or requiring new clinical efficacy data for its primary function. The "study" referenced would be the validation of the new sterilization parameters to achieve an appropriate sterility assurance level, which is mentioned as successfully completed ("The new sterilization parameters have been properly validated and result in a sterility assurance level of at least 10^-6"). Specific details of that sterilization validation study (e.g., sample size of test articles/cycles) are not provided in this public summary.

Summary

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K031204

510(k) SUMMARY

J. Morita USA, Inc.'s DENTAPORT ZX Dental Device

Name of Device and Name/Address of Sponsor

Trade or Proprietary Name:	DENTAPORT ZX
Common Name:	dental handpiece and root canal length measuring device
Classification Name:	AC-Powered Dental Handpiece and Root Apex Locator
Product Code:	EKX and LQY

J. Morita USA, Inc. 9 Mason Irvine, California USA 92618 949-581-9600 Telephone: Facsimile: 949-581-9688 Contact Person: Mr. Junichi Miyata, President Date Prepared: June 25, 2002

Intended Use

Technological Characteristics and Substantial Equivalence

The DENTAPORT ZX is a low-voltage electric motor and root canal length measuring device. The DENTAPORT ZX covered by this submission is identical in every respect to the DENTA PORT device already authorized by the FDA under K#022147. The only difference is a change in the instructions for use regarding the sterilization of the device.

The new sterilization parameters have been properly validated and result in a sterility assurance level of at least 106. Thus, the changes in sterilization parameters do not raise any new questions of safety or efficacy.

40148758.doc

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract design of an eagle with three lines representing its wings and head. The eagle is facing to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 0 2003

J. Morita USA, Incorporated C/O Mr. Keith A. Barritt 1425 K Street, N.W. Fish & Richardson P.C. 11th Floor Washington, DC 20005

Re: K031204

Trade/Device Name: Dentaport ZX Regulation Number: 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EKX, LQY Dated: May 15, 2003 Received: May 30, 2003

Dear Mr. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Barritt

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); 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.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Susan Ranger

Susan Runner, DDS MA, Interim Director Division of Anesthesiology, General, Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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U.S. Food and Drug Administration - Center for Devices and Radiological Health

Page 1 of 1

510(k) Number (if known):

Device Name: DENTAPORT ZX

Indications for Use:

Kein Marley sa RSN

Division of Anasthacinlo ontrol Denta

510(k) Number: K031204

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Optional Format 3-10-98)

40148770.doc

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.