PORTA IP SOLDER V-2

{0}------------------------------------------------ SEP 17 2002 (022467) ## Premarket Notification 510(k) # Porta IP Solder V-2 ### 5. 510 (k) Summary | Submitter of 510(k): | Wieland Dental + Technik GmbH & Co. KG | |----------------------|----------------------------------------| | | Schwenninger Str. 13 | | | D-75179 Pforzheim | | | Germany | | | Phone: +49-7231-3705-0 | | Contact person: | Dr. Gerhard Polzer | |-----------------|----------------------------------| | Phone: | +49-7231-3705-219 | | Fax: | +49-7231-357959 | | e-mail: | gerhard.polzer@wieland-dental.de | Date of Summary: 2002-06-18 Trade name: PORTA IP SOLDER V-2 Classification name: Product code: C.D.R section: Classification: Alloy, gold based, for clinical use EJT 872.3060 Class II Legally marketed equivalent device: Argesol 600 510(k) number: K 954360 #### Device description Porta IP Solder V-2 is a dental brazing alloy, that can be used by dental technicians to fabricate dental appliances for patients. It is a yellow alloy with very high contents of precious metals (Gold, Platinum, Iridium and Silver: 99,4%). Porta IP Solder V-2 is suitable for use as a filler material in operations in which dental alloy(s) parts are joined to form a dental restoration, e.g. bridges. It is intended as solder before firing for dental ceramic alloys with appropriate melting ranges and compositions, especially Porta Geo Ti, Porta SMK 82, Portalloy 54, and Simidur S1S and Simidur KF plus, which are manufactured by Wieland Dental + Technik GmbH & Co. KG, Germany. Porta IP Solder V-2 is highly corrosion resistant. It fully complies to the international standard ISO 9333 and fulfills the essential requirements of the European directive 93/42/ECC concerning medical devices. {1}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings or feathers. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SFP 1 7 2002 Dr. Gerhard Polzer Director, Regulatory Affairs Wieland Dental + Technik GmbH & Company KG Schwenninger Straße 13 D-75179 Pforzheim GERMANY Re: K022467 Trade/Device Name: Porta IP Solder V-2 Regulation Number: 21 CFR 872.3060 Regulation Name: Gold-Based Alloys and Precious Metal Alloys for Clinical Use Regulatory Class: II Product Code: EJT Dated: July 22, 2002 Received: July 26, 2002 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 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 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 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 Timoth A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Page 1 of 1 510(k) Number orta IP Solder V-2 Device Name:_ Indications For Use: Porta IP Solder V-2 is intended for use as a solder before firing in operations in which dental ceramic alloy(s) parts are joined to form a dental restoration. It should be used only together with recommended dental alloys with suitable melting ranges and compositions. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) RShetz DDS for Dr. Susan Kummer on of Anesthesiology, General Hospital, Infection Control, Dental 510(k) Number: K022467 ાર Prescription Use_ (Per 21 CFR 801.109) Over-The-Counter Use__ (Optional Formal 1-2-96)