LONE STAR IMPRESSION SYSTEMS

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure with three arms or lines extending upwards, representing health and human services. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUN - 9 1998 Mr. Edward Spehar ·Lone Star Technologies® (LST) 31 Runnymeade Road Chatham, New Jersey 07928 K980968 Re : Lone Star Impression Systems Trade Name: Requlatory Class: II Product Code: EZW Dated: March 12, 1998 Received: March 16, 1998 Dear Mr. Spehar: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the merice 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). You may, therefore, market the device, subject to the general The general controls controls provisions of the Act. 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 (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. ਰ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: 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 In addition, FDA may publish further announcements action. 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. Spehar 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 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" (21CFR 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/dsma/dsmamain.html". Sincerely yours, Timothy A. Ulatowski Director Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure______ {2}------------------------------------------------ Page of 13 510(k) NUMBER (IF KNOWN)K980968 Impression Material DEVICE NAME: INDICATIONS FOR USE: For use in taking the final Impression of prepared teeth in adult or deciduous teeth when the dentist has determined that a crown or a bridge is needed. The dentist examines the patient and determines the need for a crown or bridge. They then prepare the teeth or tooth in their usual manner. The two component impression material is then mixed manually or automatically and placed into an impression tray of the dentists' choosing. The material is then placed in the mouth and allowed to set, approx. 4 minutes, resulting in an impression of the prepared teeth. The resulting impression is then disinfected and a model is poured from this impression for use by the dentist or dental lab in preparation of the crown or bridge that is to be constructed. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANCTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) the text is: 510(k) Number