PORTADUR P 2, MODEL #2031

{0}------------------------------------------------ NOV 0 2 2001 K012843 #### Premarket Notification 510(k) Portadur P 2 ### 5. 510 (k) Summary Wieland Edelmetalle GmbH & Co. Submitter of 510(k): Schwenninger Str. 13 D-75179 Pforzheim Germany Phone: +49-7231-3705-0 2001-07-21 Contact person: Phone: Fax: : e-mail: Dr. Gerhard Polzer +49-7231-3705-219 +49-7231-357959 gerhard.polzer@wieland-dental.de Date of Summary: Portadur P 2 Trade name: Classification name: Product code: C.D.R section: Classification: Alloy, gold based, for clinical use EJT 872.3060 Class II Legally marketed Aurofluid 3 equivalent device: K911539 510(k) number: #### Device description Portadur P 2 is an extra-hard gold casting alloy with high contents of noble metals (75.1%), intended for dental technicians to fabricate dental restorations. lt has an indication which ranges from inlays/onlays and crowns up to long span bridges with two or more pontics and to removable partials. In addition, it is suitable for telescopic and milling work. Portadur P 2 is highly corrosion resistant and has an excellent biocompatibility. It fully complies to the international standard ISO 1562 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features the department's name in a circular arrangement around the perimeter. In the center of the circle is a stylized symbol that resembles an abstract representation of a human form or a bird in flight, composed of three curved lines. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 02 2001 Dr. Gerhard Polzer Director of Regulatory Affairs Wieland Edelmetalle GmbH & Company Schwenninger Strabe 13 D-75179 Pforzheim, GERMANY Re: K012843 Trade/Device Name: Portadur P 2, Model #2031 Regulation Number: 872.3060 Regulation Name:Alloy, Gold Based, For Clinical Use Regulatory Class: II Product Code: EJT Dated: October 18, 2001 Received: October 22, 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 vour 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 {2}------------------------------------------------ #### Page 2 - Dr. Polzer 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 as 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 11th lection will and w Jean 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 Part 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 Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health {3}------------------------------------------------ # NOV 0222001 K012843 Premarket Notification 510(k) Portadur P 2 ## 4. Statement of indication for use Portadur P 2 is a gold casting alloy that can be used by dental technicians to fabricate dental appliances for patients. It is intended for manufacturing - Inlays/ Onlays . - Crowns . - Short span bridges . - Long span bridges . - Removable partials . and can be used for - Telescopic and milling work . Susan Runns Chrision Sign-Off) Sien of Dental, Infection Control, · Ceneral Hospital D ் (வ Number _