APEX DAL ELECTRONIC APEX LOCATOR

K080113 · Medicnrg , Ltd. · LQY · Feb 15, 2008 · DE

Device Facts

• Record ID: K080113
• Device Name: APEX DAL ELECTRONIC APEX LOCATOR
• Applicant: Medicnrg , Ltd.
• Product Code: LQY · DE
• Decision Date: Feb 15, 2008
• Decision: SESE
• Submission Type: Special
• Device Class: Class U

Intended Use

The Apex DAL is intended for the measurement of the length of the root canal for purposes of performing root canals and related dental procedures for use by a trained professional in general dentistry.

Device Story

Apex DAL is a dental apex locator measuring root canal depth via electronic means. Device utilizes multi-frequency signals (6.5 kHz and 1.3 kHz square wave with 3 cycles) to measure tissue response between electrodes as a file advances toward the apex. DSP technology processes these signals to calculate canal length, reducing delay between calculation and display. Used in dental clinics by trained professionals; output displayed to clinician to guide root canal procedures. Benefits include accurate determination of root canal length, facilitating effective endodontic treatment.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological comparison and bench testing of the electronic measurement performance.

Technological Characteristics

Electronic apex locator using multi-frequency signal processing (6.5 kHz and 1.3 kHz square wave). Employs DSP technology for signal analysis. Device is a standalone unit for dental use. No Bluetooth connectivity.

Indications for Use

Indicated for measurement of root canal length and related dental procedures in patients requiring endodontic treatment; for use by trained general dentistry professionals.

Predicate Devices

• MedicNRG Blue Apex Locator (K071133)

Reference Devices

• MedicNRG XFG Electronic Apex Locator (K063843)
• MedicNRG Electronic Apex Locator (K032743)

Submission Summary (Full Text)

{0}------------------------------------------------

K 080113

## 510(k) Summary of Safety & Effectiveness

Pursuant to CFR 807.92, the following 510(k) Summary is provided:

| 1. (a) | Submitter<br>Address: | George J. Hattub<br>MedicSense, USA<br>291 Hillside Avenue<br>Somerset, MA 02726<br>www.medicsense.com | |
|--------|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 1. (b) | Manufacturer<br>Address: | MedicNRG, Ltd.<br>PO Box 338, MP Gordon Valley<br>Kibbutz Afikim, Israel 15148 | |
| | Mfg. Phone: | 972-4-675-4217 | |
| | Contact Person: | Michal Zach, QA Manager | |
| | Date: | January 5, 2008 | |
| 2. | Device &<br>Classification<br>Name: | Locator, Root, Apex, Class 2, Product Code LQY, unclassified<br>Apex DAL (Apex Locator) | |
| 3. | Predicate Device: | MedicNRG Blue Apex Locator (K071133) | |
| | | Earlier devices are:<br>MedicNRG XFG Electronic Apex Locator (K063843) & MedicNRG Electronic<br>Apex Locator (K032743) | |
| 4. | Description: | The Apex DAL is a dental apex locator which has the ability to measure the<br>depth of the root canal by electronic means. | |
| 5. | Intended Use: | The Apex DAL is intended for the measurement of the length of the root<br>canal for purposes of performing root canals and related dental procedures<br>for use by a trained professional in general dentistry. | |
| 6. | Comparison of<br>Technological<br>Characteristics: | With respect to technology and intended use, the Modified MedicNRG- D/<br>(Apex Locator) is substantially equivalent to its predicate device which is the<br>MedicNRG Blue Apex Locator. The primary difference is that the modified<br>device provides does not Bluetooth Wireless Capability | |
| | | Like its predicate and earlier devices (K063843, & K032743) with which the<br>device measured the tissue's changing response to the test signal between<br>the electrodes as the file is advancing toward the apex, and with the second<br>generation of Medic NRG's apex locator (K071133) it utilizes a multi-<br>frequency response signal using DSP technology with a different algorithm<br>reducing the delay between calculation and display of measurement. The<br>signals are generated as a response to multi-frequency signals having a<br>and 1.3 kHz repetition rate. The frequencies used for comparison 6.5 kHz<br>1.3 kHz Square Wave with 3 cycles used for measurement. | |
| | | Based upon the testing results, MedicNRG believes this difference does<br>raise additional safety of efficacy concerns. | |

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 15 2008

MedicNRG, Limited C/O Mr. George J. Hattub Senior Staff Consultant MedicSense, USA 291 Hillside Avenue Somerset, Massachusetts 02726

Re: K080113

Trade/Device Name: Apex DAL (Apex Locator) Regulation Number: Unclassified Regulation Name: None Regulatory Class: Unclassified Product Code: LOY Dated: January 13, 2008 Received: January 16, 2008

Dear Mr. Hattub:

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.

{2}------------------------------------------------

Page 2 - Mr. Hattub

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 [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/cdrh/industry/support/index.html.

Sincerely vours.

Susan Burns

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

{3}------------------------------------------------

## Indications for Use

11380113 510(k) Number (if known):

Device Name: Apex DAL (Apex Locator)

Indications For Use: The Apex DAL is indicated for the measurement of the length of the root canals and related dental procedures, for use by a trained professional in general dentistry.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Quars

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

Page 1 of 1

KOXO)13 510(k) Number: _______________________________________________________________________________________________________________________________________________________________