JEL-20

{0}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 2 2 2001 Mr. Raphael Judkins Manager of Regulatory Affairs J.F. Jelenko & Company, Incorporated 99 Business Park Drive Armonk, New York 10504 K012303 Re : Trade/Device Name: JEL-20 Regulation Number:872.3060 Regulatory Class: II Product Code: EJS Dated: July 19, 2001 Received: July 20, 2001 Dear Mr. Judkins: 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 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 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations 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 Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (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 requlation may result in regulatory {1}------------------------------------------------ Page 2 - Mr. Judkins 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 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 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/dsma/dsmamain.html". Sincerely yours, Olin S. L/on Timothy A. Ulatowsk Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Image /page/2/Picture/0 description: The image contains the text "K012303" on the top line and the word "Heraeus" on the second line. The text "K012303" appears to be handwritten, while the word "Heraeus" is in a bold, sans-serif font. The word "Heraeus" is larger in size than the text above it. The image is in black and white. Heraeus Kulzer, Inc. 99 Business Park Drive Armonk, NY 10504 (914) 273-8600 ## INDICATIONS FOR USE Page 1 of 1 **510(k) Number:** K012303 Device Name (s): Jel-20 This is a white Type III Crown & Bridge alloy for single & ¾ crowns, inlays, veneer crowns, and short span bridges. MACCaff La MSR (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _ (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) ## concurrence of chrd, office of device evaluation (oed) Prescription use (Per 21 CFR 801.109) OR Over-The-Counter Use Image /page/2/Picture/14 description: The image shows the logo for Heraeus Kulzer. The logo is in black and white, with the words "Heraeus" and "Kulzer" stacked on top of each other. There is a horizontal line extending from the right side of the word "Kulzer". The logo is simple and modern.