SONIC SCALER WITH FIBER OPTIC, MODEL NAS-L, SONIC SCALER WITHOUT FIBER OPTIC, MODEL NAS-NL

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge of the circle. Inside the circle is a stylized image of an eagle. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN 23 1999 Mr. Hiroji Sekiguchi Marketing Manager-North America Official Correspondent Nakanishi, Incorporated 340 Kamihinata, Kanuma-Shi, Tochiqi-Ken 322 JAPAN Re : K991021 Sonic Scaler with Fiber Optic, Model NAS-L, Trade Name: Sonic Scaler with Fiber Optic, Model NAS-NL Regulatory Class: II Product Code: ELC March 26, 1999 Dated: March 29, 1999 Received: Dear Mr. Sekiguchi: 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 aqainst 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Reqister. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of {1}------------------------------------------------ Page 2 — Mr. Sekiguchi the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acboirson in four in four alence 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 (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html". Sincerely yours, Timothy A. Ulatowski Directdr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 510(k) Number (if known): 1991021 Devicc Namc: Indications For Usc: This device, an air-powered, fiber optic, swivel air scaler, is intended for use to remove calculus deposits and stains from a tooth, as done in normal dental scaling operation . The device uses controlled water spray and an appropriate scaling tip to wash away removed calculus and stains. ## (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Coucurcuce of CDRH, Office of Device Evaluation (ODE) | | <div> <p>Susan Runne</p> <p>(Division Sign-Off)</p> <p>Division of Dental, Infection Control, and General Hospital Devices</p> </div> | | |---------------|---------------------------------------------------------------------------------------------------------------------------------------|--| | 510(k) Number | K991021 | | | Prescription Use | OR | Over-The-Counter Use | |----------------------|----|----------------------| | (Per 21 CFR 801.109) | | | (Optional Formal I - ## 4 - 1