AURECAST 10

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a logo for AUREX. The logo consists of three overlapping triangles, forming a complex geometric shape. Below the triangles, the word "AUREX" is written in capital letters, with a line underneath it. The logo is black and white. P.O. Box 509 Edenvale 1610 Republic of South Africa Telephone : +27 (11) 609-8640 Telefax : +27 (11) 452-3918 K972938 AUG 25 1997 ## 510 (k) Summary AURECAST 10 Trade name: Common name: Dental casting alloy Classification name: Gold based alloys and precious metal alloys for clinical use Class ification number: EJT Legally marketed device: Aurium Aurolite CB-25 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 | Ru | Ir | | Legal | AuroliteCB-25 | 10 | 59.9 | 20 | 9 | x | 0 | x | | New | Aurecast 10 | 10 | 59.9 | 20 | 9 | 1.0 | 0.1 | 0 | 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 | AuroliteCB-25 | 1000 | 1030 | 160 | 270 | 410 | 560 | 10 | 3 | 10.6 | | New | Aurecast 10 | 1000 | 1030 | 160 | 270 | 410 | 560 | 15 | 8 | 10.6 | ## Discussion The major components of the two alloys are identical and their concentration is the same. The only difference is in the small amount of Zn and the grain refiners such as Ru and Ir. These minor differences have negligible effect upon the alloys. ## Conclusion The two alloys are practically identical Image /page/0/Picture/18 description: The image shows a logo with the text "TUV CERT" stacked on top of each other. The logo is enclosed in a rectangular box with rounded corners. Below the text, it says "ISO 9001". There are two curved lines above the text. Aurex Precious Metal Industries (Pty) Limited (Reg. No. 88/04891/07) Manufacturers and Refiners of Precious Metals for Dental, Jewellery and Industrial applications Directors: J.D. Davis (Managing) S. Engelberg D. Wagenheim {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is a stylized image of a bird with its wings spread. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Jerome D. Davis Managing Director Aurex Precious Metal Industries (Pty) Ltd. P.O. Box 509 Edenvale 1610 Republic of South Africa Re : K972938 Trade Name: Aurecast 10 Requlatory Class: II Product Code: EJT Dated: June 13, 1997 Received: June 20, 1997 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 requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your device in the Federal Reqister. 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 Time A Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ AURECAST 10 levice 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) Swan Runner Division Sign-Off) Division of Dental, Infection Control, and General Hospital I 510(k) Number -Prescription Use y/2 er 21 CFR 801.109) OR Over-The-Counter Use No (Optional Format 1-2-96)