← Product Code LQY · K063843 # APEXNRG XFR (K063843) _Medicnrg , Ltd. · LQY · Jan 3, 2007 · DE · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K063843 ## Device Facts - **Applicant:** Medicnrg , Ltd. - **Product Code:** LQY - **Decision Date:** Jan 3, 2007 - **Decision:** SESE - **Submission Type:** Special - **Device Class:** Class U - **Review Panel:** DE ## Intended Use The ApexNRG XFR 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 ApexNRG XFR is a dental apex locator; measures root canal depth via electronic means. Used by trained dental professionals in clinical settings. Device inputs electrical signals via electrodes placed in the root canal; processes signals to determine canal length; outputs measurement via LED display. Provides finer resolution compared to predicate. Assists clinicians in accurate root canal length determination; facilitates dental procedures. ## Clinical Evidence No clinical data provided; substantial equivalence based on technological characteristics and bench testing results. ## Technological Characteristics Electronic apex locator; utilizes electrical impedance sensing to determine root canal length. Features an LED display for output. Connectivity is standalone. Modifications from predicate include improved LED resolution and updated electrode connection design. ## Predicate Devices - MedicNRG Electronic Apex Locator ([K032743](/device/K032743.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K063843 ## 510(k) Summary of Safety & Effectiveness Pursuant to CFR 807.92, the following 510(k) Summary is provided: | 1. (a) Submitter Address: | George J. Hattub
MedicSense, USA
291 Hillside Avenue
Somerset, MA 02726
www.medicsense.com | |-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1. (b) Manufacturer Address: | MedicNRG, Ltd.
PO Box 338, MP Gordon Valley
Kibbutz Afikim, Israel 15148 | | Mfg. Phone: | 972-4-675-4217 | | Contact Person: | Michal Zach, QA Manager | | Date: | December 20, 2006 | | | JAN - 3 2007 | | 2. Device & Classification Name: | Locator, Root, Apex, Class 2, Product Code LQY, unclassified
ApexNRG XFR (Apex Locator) | | 3. Predicate Device: | MedicNRG Electronic Apex Locator (K032743) | | 4. Description: | The ApexNRG XFR is a dental apex locator which has the ability to
measure the depth of the root canal by electronic means. | | 5. Intended Use: | The ApexNRG XFR 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. | | 6. Comparison of Technological Characteristics: | With respect to technology and intended use, the Modified ApexNRG XFR
(Apex Locator) is substantially equivalent to its predicate device which is the
Original MedicNRG Electronic Apex Locator. The primary differences are
that the modified device provides finer resolution in terms of its LED display
and the electrode connections has been changed. Based upon the testing
results, MedicNRG believes these differences do not 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 and Human Services. The logo features a stylized depiction of an eagle with three lines representing its wings and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol. The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MedicNRG, Limited C/O Mr. George J. Hattub Senior Staff Consultant MedicSense, USA 291 Hillside Avenue Somerset, Massachusetts 02726 JAN - 9 2007 Re: K063843 Trade/Device Name: ApexNRG XFR (Apex Locator) Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: LQY Dated: December 20, 2006 Received: December 26, 2006 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 (240) 276-0115. 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/industry/support/index.html. Sincerely yours. Sosen Quape 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}------------------------------------------------ K063843 ## Indications for Use 510(k) Number (if known): Device Name: ApexNRG XFR (Apex Locator) Indications For Use: The ApexNRG XFR 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) Super Ronn Page 1 of 1 tions of Anesthesiology, General Hospital, ction Control, Dental Devices KC063893 ) --- **Source:** [https://fda.innolitics.com/device/K063843](https://fda.innolitics.com/device/K063843) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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