APEX NRG

K032743 · Medicnrg , Ltd. · LQY · Mar 15, 2004 · DE

Device Facts

• Record ID: K032743
• Device Name: APEX NRG
• Applicant: Medicnrg , Ltd.
• Product Code: LQY · DE
• Decision Date: Mar 15, 2004
• 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, for use by a trained professional in general dentistry.

Device Story

Apex NRG is an electronic apex locator used during root canal procedures. It measures the distance from the apical foramen to an endodontic file inserted into the canal. The device applies a low-frequency, low-voltage AC signal between a lip electrode (metal hook) and the endodontic file (attached to a file clasp). It measures the impedance of tissues between these electrodes; multi-frequency analysis minimizes errors caused by conductive materials like blood in the canal. The device calculates the ratio of impedance values to determine the file tip position relative to the apex. It features an LED display and is powered by a 200mAH CR2032 battery. Used in dental clinics by trained professionals, the device provides real-time feedback to assist in accurate root canal length determination, potentially improving procedural outcomes.

Clinical Evidence

Clinical study conducted at Hebrew University, Jerusalem, involving 69 root canals from 30 teeth. Compared Apex NRG, ROOT ZX, and Apit 7 against radiographic working length. Results showed Apex NRG performance was nearly identical to ROOT ZX and highly consistent with radiographic measurements.

Technological Characteristics

Electronic apex locator; impedance-based sensing; multi-frequency (6.5 kHz - 1.3 kHz) signal processing; powered by 200mAH CR2032 battery; LED display; includes lip hook, file clasp, and apron clasp; 31g weight; automatic on/off switch; no audio indicator.

Indications for Use

Indicated for trained dental professionals performing root canal procedures to measure root canal length.

Predicate Devices

• JUSTWO TME-601 Root Apex Locator (K022020)
• ROOT ZX (K921979)

Reference Devices

• Apit 7

Submission Summary (Full Text)

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MAR 1 5 2004

K032743

### MEDICALIA

### 510(k) Summary of Safety and Effectiveness

The Following 510(k) Summary of Safety and Effectiveness has been prepared pursuant to requirements for 510(k) summaries specified in 21 CFR § 807.92(a).

#### 807.92(a)(1) - Submitter Details:

| Submitter name: | MedicNRG Ltd. |
|--------------------------|--------------------------------------------|
| Address: | Kibbutz Afikim, Israel 15148 |
| Tel/Fax: | [phone] |
| Preparer of application: | MedicNRG Ltd. |
| Address: | P.O.Box 367, Ramat Ha'Sharon, Israel 47103 |
| Phone number: | [phone] |
| Fax number: | [phone] |
| Official Correspondent: | Adi Ickowicz |
| Phone number: | [phone] |
| Fax number: | [phone] |
| Mobile: | [phone] |
| e-mail: | [e-mail] |

July 25, 2003

#### 807.92(a)(2) - Device Details:

| Trade Name: | Apex NRG - Electronic Apex Locator |
|----------------------------|------------------------------------|
| Common Name: | Apex Locator |
| Classification Regulation: | 510(k) non exempt |
| Class: | Unclassified |
| Product Code: | LQY - LOCATOR, ROOT APEX |

Date:

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### MEDICNIA

### 807.92(a)(3) — Predicate Devices:

| Medical Device<br>Name | Applicant Name | 510(k)<br>Number | Classification |
|-------------------------------------|--------------------------------------------------------|------------------|----------------|
| JUSTWO TME-601<br>Root Apex Locator | Toei Electric Co,<br>POBox 7007<br>Deerfield, IL 60015 | K022020 | unclassified |
| ROOT ZX | J. Morita USA, Inc.<br>9 Mason<br>Irvine, CA 92618 | K921979 | unclassified |

Additional Substantial Equivalence Information is provided in the attached Substantial Equivalence Comparison Table.

#### 807.92(a)(4) - Device Description:

The Apex NRG is used to measure the distance to the apex during root canal procedures. A low frequency low volt AC signal is applied between the lip electrode and the endodontic file, which is inserted into the root canal. The impedance of the tissues between the electrodes change as the file advances toward the root apex and the measured signals are used to monitor the progress of the file in the tooth.

The Apex NRG operates on the measurement of a weak electrical current flowing between two electrodes. One electrode is a metal hook that rests on the patient's lower lip and the other is the endodontic file that is attached to the file clasp and inserted into the canal. Multi frequencies are used to minimize errors that may be introduced by the entrance of conducting materials such as blood into the canal.

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# MEDICALIA

The ratio of the impedance values measured in the canal and lip are calculated to provide a measure of the probe tip relative to the apical foramen. The device consists of a main body incorporating the display, a lip hook, a file clasp and an apron clasp. The device is powered by one 200mAH CR2032 battery

### 807.92(a)(5) -- Device Intended Use:

Measurement of the length of the root canal for the purpose of performing root canals and related dental procedures, for use by a trained professional in general dentistry.

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# MEDICAI:(ન

### 807.92(a)(6) – Substantial Equivalence Comparison Table:

| | Candidate Device | Predicate Devices | |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Characteristic | Apex NRG | ROOT ZX (K921979) | JUSTWO TME-601<br>Root Apex Locator<br>(K022020) |
| Intended Use | To measure the<br>length of the root<br>canal for the purpose<br>of performing root<br>canals and related<br>dental procedures for<br>use by a trained<br>professional in<br>general dentistry. | Measurement of the<br>root canal for the<br>purpose of<br>performing root<br>canals and related<br>dental procedures. | To measure the length<br>of the root canal for the<br>purpose of performing<br>root canals and related<br>dental procedures for<br>use by a trained<br>professional in general<br>dentistry |
| Power Source | One CR2032 battery<br>200mAH | 5 AA batteries | 4 AAA batteries |
| Electric Current | Less than 40 µA | Less than 10 µA | Less than 10 µA |
| Method of<br>calculating<br>location of root<br>canal apex | Comparison of<br>impedance at multi<br>frequencies | Comparison of<br>impedance at two<br>frequencies | Measurement of<br>current at two<br>frequencies |
| Frequencies used<br>for comparison | 6.5 kHz - 1.3 kHz | 400 Hz - 8000 Hz | 500 Hz - 200 Hz |
| Number of cycles<br>used for<br>measurement | Multi frequency | 2 | 2 |
| Display | LED | Liquid crystal | Analog |
| Adjustment before<br>measurement | Unnecessary | Unnecessary | Unnecessary |
| Measuring Voltage | Up to 15 mV | 80 mV | 50 mV |
| Audio location<br>indicator | No | Yes | Yes |
| Weight | 31 g | 550 g | 280 g |
| Use with standard<br>dental file | Yes | Yes | Yes |
| Automatic On/Off<br>switch | Yes | No | Yes |

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# MEDICALIA

#### Clinical Testing:

A clinical study was performed at the Department of Endodontic, School of Dental Medicine Hebrew University; Jerusalem Israel comparing the Apex NRG with two commercially distributed apex locators; the Root ZX™ and the Apit 7™ to radiographic working length. Each patient was evaluated using the Apex NRG, the ROOT ZX and in some cases randomly using the Apit 7™, and the radiographic method. The study included 69 root canals from 30 teeth. The electronic readings were compared to those of the radiographs working length, which were determined by the investigators. The results obtained from the ROOT ZX and the Apex NRG were nearly identical and were similar to those obtained by radiography. The results obtained from the Apit 7™ were in high agreement to both the ROOT ZX and the Apex NRG.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 5 2004

MedicNRG Limited C/O Mr. Adi Lckowicz Official Correspondents Medicsense P.O. Box 367 Ramat Ha' Sharon, ISRAEL 47103

Re: K032743

Trade/Device Name: Apex NRG- Electronic Apex Locator Regulation Number: Unclassified Regulation Name: Nonc Regulatory Class: None Product Code: LQY Dated: December 1, 2003 Reccived: January 12, 2004

Dear Mr. Ickowicz :

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 cither 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. Ickowicz

Please be advised that F.DA'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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrls/dsma/dsmamain.html

Sincerely yours,

Chiu Lin, Ph.D.

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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#### D. Statement of Indication for Use

510(k) Number (if known): K032743

Device Name: Apex NRG - Electronic Apex Locator

Indication For Use:

Measurement of the length of the root canal for the purpose of performing root canals and related dental procedures, for use by a trained professional in general dentistry.

(PLEASE DO NOT WRITE BELOW THE LINE – CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODF)

Prescription Use (Per 21 CFR 801.109)

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Over-The-Counter Use

(Optional Format 1-2-96)

Kace Mulhep for MSR

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental

510(k) Number. K032743