AGC SPEZIALLEGIERUNG

{0}------------------------------------------------ Ko20347 ### Premarket Notification 510(k) # AGC Speziallegierung ## 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: 2001-12-14 Trade name: AGC Speziallegierung Classification name: Product code: EJT C.D.R section: Classification: Alloy, gold based, for clinical use 872.3060 Class II Legally marketed equivalent device: BioPorta G 510(k) number: K 012826 ## Device description AGC Speziallegierung is a gold-platinum ceramic alloy with a high content of noble metals (97,5%), intended for dental technicians to fabricate dental restorations. It has an indication which ranges from inlays/onlays and single crowns up to long span bridges with two or more pontics and pontics for AGC bridges. In addition, it can be used for manufacturing removable partials. It is free of copper and suitable for telescopic and milling work. AGC Speziallegierung 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. AGC Speziallegierung can be veneered with suitable dental ceramics and with dental composites, in which the golden yellow color of the alloy provides an excellent basis for manufacturing aesthetically pleasing dental restorations. {1}------------------------------------------------ # DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping wing shapes. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Dr. Gerhard Polzer Wieland Edelmetalle GmbH & Company Schwenninger Strabe 13 Pforzheim, GERMANY Re: K020347 Trade/Device Name: AGC® Speziallegierung Regulation Number: 872.3060 Regulation Name: Alloy, Gold Based, For Clinical Use Regulatory Class: II Product Code: EJT Dated: February 1, 2002 Received: February 4, 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 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 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.qov/cdrh/dsma/dsmamain.html Sincerely yours, . Ulatowski Timothy Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ NUMBER (IF KNOWN) : 510 (k) DEVICE NAME: AGC® Speziallegierung INDICATIONS FOR USE: AGC Speziallegierung is a gold-platinum ceramic 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 • Pontics for AGC bridges - · Removable partials and can be used for • Telescopic and milling work AGC Speziallegierung can be veneered with suitable dental ceramics as well as with dental-composites. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter-Use (Optional Format 1-2-96) Susan Rumpe (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number __