NSK PRECISION APEX LOCATOR (PAL)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows handwritten text in two rows. The first row contains the text "Ko5 3235", which appears to be a combination of letters and numbers. The second row contains the text "f. 1 of i", which appears to be a combination of letters and symbols. The text is written in black ink on a white background. ## 510(k) Summary of Safety & Effectiveness Pursuant to CFR 807.92, the following 510(k) Summary is provided: | 1. (a) | Submitter<br>Address: | MedicSense, Ltd.<br>Galdani Bldg<br>58b Amal St.<br>Kiriat Arie, Petach Tikya, Israel 47103<br>www.medicsense.com | |--------|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1. (b) | Manufacturer<br>Address: | NSK Nakanishi, Inc.<br>700 Shimohinata, Kanuma-shi<br>Tochigi-ken, Japan 322-8666 | | | Mfg. Phone: | 1-289-64-3422 | | | Contact Person: | Masato Hamada, North America Manager | | | Date: | November 13, 2005 | | 2. | Device &<br>Classification<br>Name: | Locator, Root, Apex, Class 2, Product Code LQY, unclassified<br>NSK Precision Apex Locator (PAL) | | 3. | Predicate Device: | MedicNRG Electronic Apex Locator (K032743) | | 4. | Description: | The NSK Precision Apex Locator is a dental medical device which has the<br>ability to measure the depth of the root canal by electronic means. | | 5. | Intended Use: | The NSK Precision Apex Locator is intended for the measurement of the<br>length of the root canal for purposes of performing root canals and related<br>dental procedures, for use by a trained professional in general dentistry. | | 6. | Comparison of<br>Technological<br>Characteristics: | With respect to technology and intended use, the NSK Precision Apex<br>Locator is substantially equivalent to its predicate device which is the<br>MedicNRG Electronic Apex Locator. The primary difference is that the NSK<br>device utilizes a LCD display whereas the NRG device utilizes a LED<br>display. Based upon testing results, NSK believes this difference does not<br>raise additional safety of efficacy concerns. | {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JAN 2 4 2006 Mr. George Hattub Senior Staff Consultant MedicSense, U.S.A. 291 Hillside Avenue Somerset, Massachusetts 02726 Re: K053235 Trade/Device Name: NSK Precision Apex Locator Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: LQY Dated: November 15, 2005 Received: November 23, 2005 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 mav, 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 docs 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 (OS) 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, Anthony D. Watson for 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 KOS 3235 510(k) Number (if known): Device Name: NSK Precision Apex Locator Indications For Use: The NSK Precision Apex Locator is intended for the 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. 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) Robert Betz DDS for Dr. Susan Runner K053235 Page 1 of 1