AURECAST 4

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a logo with a geometric design above the word "AUREX". The geometric design consists of three overlapping triangles, creating a complex shape. The word "AUREX" is written in a bold, sans-serif font, with a horizontal line underlining it. 972937 P.O. Box 509 Edenvale 1610 Republic of South Africa Telephone : +27 (11) 609-8640 Telefax : +27 (11) 452-3918 AUG 25 1997 ## 510 (k) Summary AURECAST 4 Trade name: COmmon name: Dental casting alloy Gold based alloys and precious metal alloys for clinical use Classification name: Class ification number: EJT Legally marketed device: Argen Argenco 9 Description of the device: Low gold , silver-palladium based casting alloy Intended use of the device: Type IV restorations ## Summary of the technological characteristics Test methods applied: as in ANSI/ADA 5 and ISO 8891 Comparison of composition: | ALLOY | COMPOSITION (weight%) | | | | | | | | |-------|-----------------------|----|------|------|------|-----|------|-----| | | Name | Au | Ag | Pd | Cu | Zn | Ir | Ru | | Legal | Argenco 9 | 4 | 45.7 | 30.3 | 18.5 | 1.5 | 0.05 | 0 | | New | Aurecast 4 | 4 | 45.7 | 30.3 | 17.6 | 2.3 | 0 | 0.1 | x is less than 1 % Comparison of physical and mechanical properties | ALLOY | Melting point range (°C) | | Hardness (Vickers 5/30) | | Yield strength (MPa) | | Elongation (%) | | Density (g/cm3) | | |-------|--------------------------|--------|-------------------------|------|----------------------|------|----------------|------|-----------------|------| | Name | solid | liquid | soft | hard | soft | hard | soft | hard | | | | Legal | Argenco 9 | 940 | 1020 | 195 | 265 | 460 | 700 | 10 | 3 | 10.6 | | New | Aurecast 4 | 940 | 1020 | 195 | 265 | 460 | 700 | 10 | 3 | 10.6 | ## Discussion The two alloys are practically identical. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract image of an eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Jerome D. Davis Manaqinq Director Aurex Precious Metal Industries (Pty) Ltd. P.O. Box 509 Edenvale 1610 Republic of South Africa Re : K972937 Aurecast 4 Trade Name: Requlatory Class: II Product Code: EJT Dated: June 13, 1997 June 20, 1997 Received: AUG 25 1997 Dear Mr. Davis: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 {2}------------------------------------------------ Page 2 - Mr. Davis through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations. This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/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 Radioloqical Health Enclosure {3}------------------------------------------------ 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ 'evice Name: Indications For Use: Dental casting alloy for making dental restorations and appliances. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Susan Runser (Division Sign-Off) Division of Dental, Infection Control, and General Hospital,Devices 510(k) Number K922037 Prescription Use er 21 CFR 801.109) Over-The-Counter Use No