ROOT APEX LOCATOR

K972407 · Toei Electric Co., Ltd. · LQY · Sep 11, 1997 · DE

Device Facts

• Record ID: K972407
• Device Name: ROOT APEX LOCATOR
• Applicant: Toei Electric Co., Ltd.
• Product Code: LQY · DE
• Decision Date: Sep 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

Measurement of the length of the root canal for the purpose of performing root canals and related dental procedures.

Device Story

Battery-operated root apex locator; used by dentists/oral surgeons in clinical settings. Device inputs: electrical impedance measured via standard dental file inserted into root canal. Operation: emits small electrical currents at 500 Hz and 2000 Hz; compares impedance at these frequencies to determine relative proximity of file to apex; dual-frequency approach minimizes interference from blood or medicinal fluids. Output: visual readout on stabilized analog meter; audio location indicator. Benefit: provides accurate root canal length measurement to facilitate endodontic procedures.

Clinical Evidence

Bench testing only. In vitro study using extracted teeth with straight and curved canals. Compared subject device against physical measurements, radiographic measurements, and Ingle's calculated length. Tested in dry conditions and in presence of saline and 2.5% sodium hypochlorite. Results showed no significant difference between subject device and predicate in obtaining tooth length across all media; no significant statistical difference compared to Ingle's method.

Technological Characteristics

Battery-operated (4 AAA 1.5V); analog display; audio indicator. Sensing principle: dual-frequency (500 Hz and 2000 Hz) impedance measurement. Measuring voltage: 50 mV. Current: <10 µA. Weight: ~280g. Compatible with standard dental files. Automatic on/off switch.

Indications for Use

Indicated for patients requiring root canal length measurement during endodontic or related dental procedures.

Predicate Devices

• Root ZX (K953867, K921979)

Submission Summary (Full Text)

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SEP 1 1 1997

K972407

## Summary of Safety and Effectiveness - 510(k) Summary I.

1. Submitter Information:

Toei Electric Co., Ltd. 771, Shimosakunobe Takatsu-ku, Kawasaki Kanagawa-ken 213 Japan (81)(44)877-5410

Robert P. Reznick, Esq. Contact Person: Hughes Hubbard & Reed LLP 1300 I Street, N.W. Washington, D.C. 20005 [phone]

## 2. Device Information:

Root canal length measurement device. This device is not classified.

3. Predicate Device:

Root ZX, K953867, K921979

4. Device Description:

The subject device is a lightweight, fully-automatic, battery-operated device that allows a dentist or oral surgeon to locate a patient's anatomical root canal apex and obtain accurate root canal length measurements. The device allows the relative position of a dental file and the apex to be determined electrically. Using a standard dental file inserted into the root canal as an electrode, the device emits very small electrical currents having frequencies of 500 Hz and 2000 Hz. The impedance between the file and mouth is measured at each of these frequencies, and compared, with a readout of the relative proximity to the apex appearing on a stabilized meter. The use of two frequencies minimizes errors introduced by blood or other conducting medicinal fluids in the root canal.

The subject device consists of a main body, incorporating the panel meter, a probe cord and reel, a canal instrument holder, a mouth angle clip, a saliva ejector clip, and batteries. The device operates on four AAA 1.5 v. batteries.

The subject device is intended to be used to measure the length of the root canal for the purpose of performing root canals and related dental procedures.

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| Device Characteristics | Subject Device | Root ZX |
|------------------------------------------------------|---------------------------------------------|---------------------------------------------|
| Power source | 4 AAA batteries | 5 AA batteries |
| Electric current | Less than 10 µA | Less than 10 µA |
| Method of calculating location<br>of root canal apex | Comparison of impedance at<br>2 frequencies | Comparison of impedance at<br>2 frequencies |
| Frequencies used for<br>comparison | 500 Hz & 2,000 Hz | 400 Hz & 8,000 Hz |
| Number of cycles used for<br>measurement | 2 | 2 |
| Display | Analog | Liquid crystal |
| Adjustment before<br>measurement | Unnecessary | Unnecessary |
| Measuring voltage | 50 mV | 80 mV |
| Audio location indicator | Yes | Yes |
| Weight | Approx. 280g | Approx. 550g |
| Use with standard dental files | Yes | Yes |
| Automatic on/off switch | Yes | No |

## 5. Comparison With Predicate Device:

The Subject device and the Root ZX utilize the same method of calculating root canal lengths by comparing electrical impedances at two frequencies and are substantially equivalent in all particulars.

## 6. Non-Clinical Data Necessary To A Finding Of Substantial Equivalence:

The accuracy of the subject device was confirmed using an in vitro testing model against measurements obtained physically, radiographically, and using an Ingle's calculated length. Measurements were taken in sample extracted teeth having both straight and curved canals. Measurements were also made under conditions in which the teeth were dry and in which they were in the presence of saline and 2.5% sodium hypochlorite solutions. The tests showed no significant difference between the subject device and the predicate in obtaining tooth length in each of the three media tested. Moreover, no significant statistical differences were found between readings taken by the subject device and Ingle's method.

Submitted June 26, 1997

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 1 1997

Mr. Robert P. Reznick TOEI Electric Company, LTD C/O Hughes, Hubbard & Reed LLP 1300 I Street, N.W. 20005 Washington, DC

K972407 Re : Root Apex Locator Trade Name: Regulatory Class: Unclassified Product Code: LQY June 26, 1997 Dated: Received: June 26, 1997

Dear Mr. Reznick:

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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ਸੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. 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

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Page 2 - Mr. Reznick

through 542 of the Act for devices under the Electronic enzough Siz on Control provisions, or other Federal laws or requlations.

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 qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Alatoust

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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Page__________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Root apex locator Device Name:__

Indications For Use:

Measurement of the length of the root canal for the purpose of performing root canals and related dental procedures.

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| | Susan Runner |
|---------------------------------------------------------------------|--------------|
| (Division Sign-Off) | |
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K972407 |

| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use (Optional Format 1-2-96) |
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