CERA F ALLOY

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a black and white graphic. The graphic is mostly black, with a white curved shape in the lower right corner. The black area has a textured appearance, with vertical lines and variations in tone. # 510(k) SUMMARY ### NAME & ADDRESS: SEP 3 0 2003 DENTSPLY International 70 West College Avenue O. Box 872 York, PA 17405-0872 717) 845-7511 772 840 1762 ww.dentsply.com P. J. Lehn Telefax (717) 849-4343 P. Jeffery Lehn CONTACT: July 25, 2003 DATE PREPARED: TRADE OR PROPRIETARY NAME: CERA F ALLOY Gold based alloy for clinical use (872.3060) CLASSIFICATION NAME: PREDICATE DEVICES: Stabilor NF IV alloy K951780 DEVICE DESCRIPTION: CERA F ALLOY is a gold-based dental alloy for prosthodontic devices. INTENDED USE: CERA F ALLOY is indicated as a dental alloy for fabricating inlays, crowns, bridges, precision milling bars and attachments, and crowns and bridges for porcelain fused to metal technique. TECHNOLOGICAL CHARACTERISTICS: All of the components found in CERA F ALLOY have been used in legally marketed devices. CERA F ALLOY is very similar in formulation to legally marketed dental alloys. This alloy has been on the European market since 2001 with over 250,000 units placed. Therefore, it was determined that no biocompatibility testing was necessary. We believe that the prior use of the components of CERA F ALLOY in legally marketed devices, the performance data provided, and the historical use of the device in Europe support the safety and effectiveness of CERA F ALLOY for the indicated uses. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human profiles facing to the right, stacked on top of each other. Public Health Service SEP 3 0 2003 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. P Jeffery Lehn Director of Corporate Compliance and Regulatory Affairs Dentsply International 570 West College Avenue P.O. Box 872 York, Pennsylvania 17405-0872 Re: K032321 Trade/Device Name: Cera F Alloy Regulation Number: 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: July 25, 2003 Received: July 28, 2003 Dear Mr. Lehn: 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 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 (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. Lehn Please be advised that FDA's issuance of a substantial equivalence determination does 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 (301) 594-4613. 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/dsma/dsmamain.html Sincerely yours, Suser Purse Susan Runner, DDS, MA Interim 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 STATEMENT (As Required by 21 CFR 807.87(e) 510(K) Number (if known): Device Name: CERA F ALLOY Indications for Use: Fabricating inlays, crowns, bridges, precision milling bars and attachments, and crowns and bridges for porcelain fused to metal technique. MCG Lu for MSR (Division Sign-O Division of Anesthesiology, General Hospital, Infection Control, Dental Devices 510(k) Number: ### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use _ V OR Over-The-Counter Use - (Per 21 CFR 801.109) (Optional Format 1-2-96)