EURO 45, ORDER-NO.: 2064

{0}------------------------------------------------ OCT 2 3 2001 K012840 # Premarket Notification 510(k) ## EURO 45 # 5. 510 (k) Summary | Submitter of 510(k): | Wieland Edelmetalle GmbH & Co. | |----------------------|--------------------------------| | | Schwenninger Str. 13 | | | D-75179 Pforzheim | | | Germany | | | Phone: +49-7231-3705-0 | Dr. Gerhard Poizer Contact person: +49-7231-3705-219 Phone: +49-7231-357959 Fax: gerhard.polzer@wieland-dental.de e-mail: Date of Summary: Trade name: EURO 45 2001-07-21 Classification name: Product code: C.D.R section: Classification: Alloy, gold based, for clinical use EJT 872.3060 Class II Legally marketed equivalent device: 510(k) number: Eureka Plus K 944887 ### Device description EURO 45 is a gold-palladium ceramic alloy with high contents of noble metals (79,5%) intended for dental technicians to fabricate dental restorations. lt has an indication which ranges from single crowns up to long span bridges with two or more pontics. It is free of copper and therefore suitable for telescopic and milling work. EURO 45 is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 9693 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices. EURO 45 can be veneered with suitable dental ceramics and with dental composites. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized image of an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is simple, yet recognizable, and represents the department's mission to protect the health of all Americans. OCT 2 3 2001 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Dr. Gerhard Polzer Director, Regulatory Affairs Wieland Edelmetalle GmbH & Company Schwenninger Strabe 13 Pforzheim, GERMANY Re: K012840 Trade/Device Name: Euro 45, Order-No; 2064 Regulation Number: 872.3060 Regulation Name: Alloy, Gold Based, For Clinical Use Regulatory Class: II Product Code: EJS and EJT Dated: August 23, 2001 Received: August 23, 2001 Dear Dr. Polzer: 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. 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. {2}------------------------------------------------ ## Page 2 - Dr. Polzer You must comply with all the Act's requirements, including, but not limited to: registration I ou must comply with an are reveling (21 CFR Part 801); good manufacturing practice allo listing (21 CFR Pat 807), laqslity systems (QS) regulation (21 CFR Part 820); and if requirences as set form in the quality sign control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 21 CFN 1000-1050. This letter will allow you to begin marketing your device as described in your Section I his letter will anow you to begin manoung of substantial equivalence of your device to J10(K) premarket notification. Vice 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 II you desire specific ad 1.00 for in vitro diagnostic devices), please contact the and additionally 21 CFR Fall 609110 113. Additionally, for questions on the promotion and Office of Colliphiance at (301) as contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket Anotification" (21CFR Part 807.97). Other general information on your responsibilities under notheation (21GFR Part 00197). Vision of Small Manufacturers, International and the Act may be obtained from the Brumber (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html Sincerely yours, Tim A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ # Premarket Notification 510(k) EURO 45 # 4. Statement of indication for use EURO 45 is a gold-palladium ceramic alloy that can be used by dental technicians to fabricate dental appliances for patients. KO12840 It is intended for manufacturing - . Crowns - Short span bridges . - Long span bridges . and can be used for - Telescopic and milling work . EURO 45 can be veneered with suitable dental ceramics as well as with dentalcomposites. Prescription Use (Per 21 CFR 801.109) Over-the-Counter Use. Susan Ruoss (Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number