ORION E ALLOY

{0}------------------------------------------------ ## 510(k) SUMMARY DENTSPLY NAME & ADDRESS: SEP 3 0 2003 11032316 ENTSPLY Internation 570 West College Avenu P.O. Box 872 York, PA 17405-0872 (717) 845-7511 Fax (777) 849-4762 www.dentsplv.com P. J. Lehn Telefax (717) 849-4343 P. Jeffery Lehn CONTACT: DATE PREPARED: July 25, 2003 TRADE OR PROPRIETARY NAME: ORION E ALLOY Gold-based alloy for clinical use. (872.3060) CLASSIFICATION NAME: PREDICATE DEVICES: Degubond 4 alloy K951787 ORION E ALLOY is a white high noble, gold-based dental alloy. DEVICE DESCRIPTION: INTENDED USE: ORION E is indicated for crowns, bridges, precision milling bars and attachments, and crowns and bridges for the porcelain fused to metal technique. TECHNOLOGICAL CHARACTERISTICS: All of the components found in ORION E ALLOY have been used in marketed devices or have been found to be safe for dental use. ORION E Alloy is very similar in formulation to legally marketed dental alloys. This alloy has been on the European market since 1999 with over 40.000 units placed; the predicate device has been marketed since 1981. Therefore, it was determined that no biocompatibility testing was necessary. We believe that the prior use of the components of ORION E ALLOY in legally marketed devices, the performance data provided, and the historical use of the device in Europe support the safety and effectiveness of ORION E ALLOY for the indicated uses. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's symbol, which consists of three stylized lines that resemble a human figure. The symbol is positioned to the right of the department's name, which is written in a circular pattern around the symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 ## SEP 3 0 2003 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: K032316 Trade/Device Name: Orion E 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, Paris 800 to 898. In addition. FDA may publish further announcements concerning your device in the Federal Register. {2}------------------------------------------------ Page 2 - Mr. Lehn lease 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 (QS) 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 Sincerelv vours. Susan Runner 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: ORION E ALLOY Indications for Use: Fabricating crowns, bridges, precision milling bars or attachments, and crowns and bridges for porcelain fused to metal technique. Mh. Walker for MSR **510(k) Number:** K032316 (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDE! Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96) Premarket Notification ORION E ALLOY Page 7