HI DENSE TC

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Hideaki Kumazawa Vice President and Official Correspondent Shofu Dental Corporated , 4025 Bohannon Drive 94025 Menlo Park, California JUN 30 1997 Re : K971927 Hi Dense TC Trade Name: Requlatory Class: II Product Code: EMA Dated: May 22, 1997 May 27, 1997 Received: Dear Mr. Kumazawa: 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic (QS) 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 the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 {1}------------------------------------------------ Page 2 - Mr. Kumazawa through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations. This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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, thy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ K971927 510(k) Number: HI DENSE TC Device Name: ## Indications For Use: HI DENSE TC is a glass ionomer sliver reinforced restorative dental product. It is indicated for use in: - 1. Class I and II cavities in deciduous teeth. - 2. Repair of amalgam restored teeth when either tooth or restoration has fractured. - 3. Class I and II cavities in selected permanent teeth. - 4. Lining under amalgam and posterior composite restorations. - 5. In other classes of cavity where radiopacity rather than aesthetics is a prime requirement. - 6. As a core build-up material under crowns. - 7. On the root surfaces for locating overdentures. - 8. Long term temporary replacements for cusp(s). - 9. Repair to crown margins. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) | (Division Sign-Off) | | |----------------------------------------|--------| | Division of Dental, Infection Control, | | | and General Hospital Devices | | | 510(k) Number | K97927 | | Prescription Use | <div style="display:inline-block;"> <span style="text-decoration:underline;">✓</span> </div> | OR | Over-The-Counter Use ______ | |---------------------|----------------------------------------------------------------------------------------------|----|-----------------------------| | (Per 21CFR§801.109) | | | | (Optional Format 1-2-96)