(171 days)
The DENTA PORT 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.
The DENTA PORT is composed of a canal measurement base module (the DP-RCM module) and a canal enlargement module (the DP-TR module). The DP-RCM module can be used alone and has a root canal measurement capability. The DP-TR module can be used only when it is connected to the DP-RCM module. When connected, 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 device measures electrical impedance (400, 8000 Hz) between the electrode (root canal file) located inside of the opened root canal and an oral mucous electrode, calculating the ratio of two impedance values, and thereby indicating the position of the file tip inside the root canal.
This 510(k) summary for the J. Morita Manufacturing Corporation's DENTA PORT Dental Device does not contain the kind of detailed information typically found in a study proving a device meets acceptance criteria. It primarily focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and intended use, rather than presenting performance data from a specific study against predefined acceptance criteria.
Therefore, many of the requested sections will state that the information is "Not provided in the document."
Here's an attempt to extract the available information and note the missing data:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not explicitly stated as criteria in the document) | Reported Device Performance (as described for the DENTA PORT) |
|---|---|
| (Implicit: Accurate root canal length measurement) | "The root canal length can be measured in a simple and safe way by measuring electrical impedance (400, 8000 Hz) between the electrode (root canal file) located inside of the opened root canal and an oral mucous electrode, calculating the ratio of two impedance values, and thereby indicating the position of the file tip inside the root canal." |
| (Implicit: Effectiveness in various canal conditions) | "The DENTA PORT requires no adjustments or calibrations and can be used whether the canal is dry or filled with strong electrolytes such as blood, hydraulic saline, etc. The size of the file has almost no effect on the measurement." |
| (Implicit: Continuous monitoring during enlargement) | "Since the position of the file tip and the meter reading are directly related, root canal enlargement can easily be performed while continuously monitoring the length of the canal electrically." |
| (Implicit: Effectiveness of motor/enlargement features) | DP-TR module features: Auto Start/Stop, Auto Apical Reverse, Auto Torque Reverse, Auto slow down. Measures electrical impedance to indicate file tip position and uses this for motor movement. Enables mechanical preparation and removal of gutta-percha. |
| (Implicit: Safety) | "This allows the dentist to safely and efficiently perform canal enlargements of root canals." (for DP-RCM) and "This allows the dentist to safely and efficiently perform the mechanical preparation of root canals and the mechanical removal of gutta-percha points." (for DP-TR) |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not provided in the document.
- Data Provenance (country of origin, retrospective/prospective): Not provided in the document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not provided in the document. This document does not describe a clinical study with expert-established ground truth.
4. Adjudication Method for the Test Set
- Not provided in the document. No test set or adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was one done? No. The document does not describe an MRMC study.
- Effect size of human readers improvement with AI vs. without AI assistance: Not applicable, as no such study is presented.
6. Standalone (Algorithm Only) Performance Study
- Was one done? No. The document describes the device's operational principles and features, but not a standalone performance study with quantitative results.
7. Type of Ground Truth Used
- Not provided in the document. The document relies on technological characteristics and intended use for substantial equivalence, not a specific ground truth type from a performance study.
8. Sample Size for the Training Set
- Not applicable. This device is described as operating based on electrical impedance measurements and not as an AI/machine learning algorithm that requires a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no mention of a training set or its associated ground truth establishment.
Summary of what the document does provide in relation to criteria/performance:
The 510(k) summary focuses on describing the technological characteristics and intended use of the DENTA PORT device and comparing them to a predicate device (Tri Auto ZX). The acceptance "criteria" are implicitly met by the device's design and functionality, which are presented as similar to the legally marketed predicate device. The document asserts that these similarities mean the DENTA PORT raises no new issues of safety or effectiveness. It details how the device measures root canal length using electrical impedance and its features for canal enlargement and monitoring. However, it does not contain specific quantitative performance metrics from a dedicated clinical study or validation against pre-defined numerical acceptance criteria for accuracy, precision, or diagnostic performance.
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510(k) SUMMARY
J. Morita Manufacturing Corporation's DENTA PORT Dental Device
DEC 2 0 2002
Name of Device and Name/Address of Sponsor
Trade or Proprietary Name: DENTA PORT dental handpiece and root canal length measuring device Common Name: 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 Telephone: 949-581-9600 949-581-9688 Facsimile: Contact Person: Mr. Junichi Miyata, President Date Prepared: June 25, 2002
Intended Use
The DENTA PORT 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.
Technological Characteristics and Substantial Equivalence
The DENTA PORT is composed of a canal measurement base module (the DP-RCM module) and a canal enlargement module (the DP-TR module).
The DP-RCM module can be used alone and has a root canal measurement capability. It can be used to measure the length of the canal.
The DP-TR module can be used only when it is connected to the DP-RCM module. When connected, 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 DP-RCM base module
The root canal length can be measured in a simple and safe way by measuring electrical impedance (400, 8000 Hz) between the electrode (root canal file) located inside of the opened root canal and an oral mucous electrode, calculating the ratio of two impedance values, and thereby indicating the position of the file tip inside the root canal. This allows the dentist to safely and efficiently perform canal enlargements of root canals.
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- The DENTA PORT requires no adjustments or calibrations and can be used whether the canal is dry or filled with strong electrolytes such as blood, hydraulic saline, etc. The size of the file has almost no effect on the measurement.
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- Since the position of the file tip and the meter reading are directly related, root canal enlargement can easily be performed while continuously monitoring the length of the canal electrically.
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- The meter is an easy-to-read liquid crystal display.
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- The position of the file tip is easily determined by the changes in the monitor's audible signals.
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- The unit is powered by commonly available "AA" batteries. Low power consumption enhances long battery life.
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- The file holder and contrary electrode can be autoclaved.
The DP-TR module connected to DP-RCM base module
The DP-TR module connected to the DP-RCM module has the same functions as the DP-RCM module alone, such as root canal measurement, plus it has a dental micromotor and can be used with root canal files. With the accompanying root canal files, the DP-TR enables the mechanical preparation of dental root canals and the removal of gutta-percha points. During the mechanical preparation of the dental root canal, the device measures electrical impedance (400, 8000 Hz) between the file electrode connected to the root canal and an oral mucous electrode by calculating the ratio of two impedance values and indicating the position of the file tip inside the root canal. The device also uses this information for motor movement. This allows the dentist to safely and efficiently perform the mechanical preparation of root canals and the mechanical removal of guttapercha points.
The DP-TR module has the following features.
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- Auto Start / Stop
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- Auto Apical Reverse
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- Auto Torque Reverse
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- Two types of motors are available.
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The position of the file tip is monitored and displayed while the canal is being enlarged.
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In manual mode, the motor rotates even when the file is outside the root canal.
When the files are inside the root canal, the device switches to automatic mode.
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A foot switch is available. When it is turned on, the motor rotates even when the file is outside the root canal. When the file is inside the root canal, the device switches to automatic mode.
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Auto slow down is available. When auto slow down is set, the motor rotation speed is reduced automatically when the tip of the file comes near the apex.
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Files are easy to replace by the push chuck.
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The volume of the audible signals can be adjusted or turned off.
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The contra head, file holder, and contrary electrode can be autoclaved as long as the temperature does not exceed 135°C.
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Only nickel-titanium files can be used with the DP-TR module for
mechanical preparation of inside the root canal.
- A rechargeable battery is used for power supply.
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The DENTA PORT is substantially equivalent to the Tri Auto ZX (K#970339) because both devices have similar general intended uses, technological characteristics, and operating principles.
The principal differences in the technological characteristics between the DENTA PORT and the Tri Auto ZX are: (1) the DENTA PORT is composed of two modules; (2) the motor of the DENTA PORT has tubing and the Tri Auto ZX does not; (3) the free running speeds are different; (4) the DENTA PORT has two types of motors while the Tri Auto ZX has one; (5) the DENTA PORT has an auto slow down feature; (6) the DENTA PORT uses an LCD while the Tri Auto ZX uses an LED display; and (7) the DENTA PORT has a foot switch.
These differences do not raise any new issues of safety or effectiveness. As such, the DENTA PORT raises no new issues of safety or effectiveness.
40123747.doc
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and body. The eagle is enclosed in a circle of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 0 2002
·J. Morita Manufacturing Company C/O Mr. Keith Barritt Fish & Richardson P.C. 1425 K Street, N.W. 11th Floor Washington, D.C. 20005
Re: K022147
Trade/Device Name: DENTA PORT Regulation Number: None and 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: Unclassified and I Product Code: LOY and EKX Dated: October 10, 2002 Received: October 11, 2002
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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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. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.goy/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski 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): K#022147
Device Name: DENTA PORT
Indications for Use:
The DENTA PORT 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.
(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)
Susa Rooser
(Division Sign-Off) Division of Anesthesiology, General Hospital. Infection Control, Dental Devices
510(k) Number. K022047
40123748.doc
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