AURECAST 2

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a logo with two overlapping triangles at the top and the word "AUREX" at the bottom. The triangles are solid black and appear to be slightly offset from each other. The word "AUREX" is in a bold, sans-serif font, and there is a horizontal line directly underneath it. The overall design is simple and geometric. P.O. Box 509 Edenvale 1610 Republic of South Africa Telephone : +27 (11) 609-8640 Telefax : +27 (11) 452-3918 AUG 25 K972936 ## 510 (k) Summary Trade name: COmmon name: Classification name: Class ification number: AURECAST 2 Dental casting alloy Gold based alloys and precious metal alloys for clinical use EIT Legally marketed device: Jelenko Maestro Description of the device: 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 | Sn | Ir | | Legal | Maestro | 3 | 50 | 30 | 15.9 | 1 | 0 | x | | New | Aurecast 2 | 1.9 | 52.9 | 25.6 | 17.3 | 1 | 1 | 0.3 | 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 Maestro | 940 | 1025 | 225 | 270 | 425 | 606 | 18 | 8 | 10.7 | | New Aurecast 2 | 885 | 960 | 195 | 220 | 420 | 600 | 17 | 6 | 10.4 | ## Discussion The constituents above 1% are the same. The concentration difference in the major components (silver and palladium) is only 2 and 4 %, respectively. ## Conclusion The mechanical properties of the two alloys are very similar (especially tensile properties), and considering the constitutions it may be assumed that also the chemical properties and biological effect should be very similar. Image /page/0/Picture/22 description: The image shows a logo with the text "TUV CERT" inside of a rounded square. The letters "TUV" are stacked on top of the word "CERT". The logo is black and white. The logo appears to be a certification mark. Aurex Precious Metal Industries (Pty) Limited (Reg.No. 88/04891/07) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird-like figure. The logo is simple and iconic, representing the department's mission to protect the health of all Americans. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Jerome D. Davis 'Manaqing Director Aurex Precious Metal Industries (Pty) Ltd. P.O. Box 509 Edenvale 1610 Republic of South Africa AUG 25 1997 K972936 Re : Aurecast 2 Trade Name: Regulatory Class: II Product Code: EJT Dated: June 13, 1997 Received: June 20, 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 reqistration, 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 Existing major be subject to such additional controls. requlations affecting your device can be found in the Code of Federal Regulations, 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 General requlation (21 CFR Part 820) and that, Devices: 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. concerning your device in the Federal Reqister. 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 Chrough 542 or the nee re- rovisions, or other Federal laws or requlations. This letter will allow you to begin marketing your device as Inis receir writ as 0 (k) premarket notification. The FDA described in your sie(if promatence of your device to a legally marketed predicate device results in a classification for your marketed predicate device robates to proceed to the market. If you desire specific advice for your device on our labeling II you desire specific advice additionally 809.10 for in regulation (21 crk rares), please contact the Office of vicio diagnostic devices) , productionally, for questions on Compilance at (501) 554 rsing of your device, please contact the Dromocion and adversibling on 1301) 594-4639. Also, please note the Office of Comprised, "Misbranding by reference to the regulation Chercrea, (21 CFR 807.97) -Other general information on your responsibilities under the Act may be Information on your responsible in and Manufacturers Assistance obcarned from ene brying (800) 638-2041 or (301) 443-6597 or at at Its COII-Tree namber (os)/ 350 - 35 - 50 - 6 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - Sincerely yours, Timothy A. Ulatowski Timo 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 2 'evice Name: Indications For Use: 关于 5-2 335 Dental casting alloy for making dental restorations and appliances. is not indicated for use with don't a posislaw, (this ally (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) from the may be the country of the country of the county of the county of the county of the county of the county of the country of the county of the county of the county of t Mino (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_ 897293 Prescription Use W `er 21 CFR 801.109) OR Over-The-Counter Use No (Optional Format 1-2-96)