AURECAST BIO 59PF

{0}------------------------------------------------ K972939 AUG 2 S Image /page/0/Picture/2 description: The image shows a logo for AUREX. The logo consists of two overlapping triangles, with the word "AUREX" written below them. There is a line underneath the word AUREX. The triangles and text are black, and the background is white. P.O. Box 509 Edenvale 1610 Republic of South Africa Telephone : +27 (11) 609-8640 Telefax : +27 (11) 452-3918 ### -5- # 510 (k) Summary | Trade name: | AURECAST BIO 59 PF | |----------------------------|--------------------------------------------------------------| | Common name: | Dental casting alloy | | Classification name: | Gold based alloys and precious metal alloys for clinical use | | Class ification number:EJT | | Legally marketed device: Jelenko Sturdicast Description of the device: High gold 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 | Pt | Pd | Cu | Zn | In | Ir | | Legal | Sturdicast | 60 | 22 | 0 | 3.8 | 14 | 0 | x | x | | New | AurecastBio59PF | 58.9 | 23 | 4.1 | 0 | 12.3 | 1.5 | 0 | 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 Sturdicast | 860 | 905 | 175 | 270 | 352 | 703 | 40 | 8 | 14.1 | | New Aurecast | 858 | 884 | 205 | 270 | 345 | 520 | 19 | 6 | 14.2 | | Bio59PF | | | | | | | | | | #### Discussion The noble metal content of the two alloys differs very little (2%). The (Ag+Cu) content is also very close. Aurecast Bio59PF uses Zn as deoxidizing agent. Physical and mechanical properties shoe only little difference. #### Conclusion With the exception of a very small amount of Zn and In the two alloys have similar constitution and mechanical characteristics. It may be assumed that the corrosion and tamish resistance and the biological effect do not differ substantially. == {1}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it. Above the caduceus, the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular fashion. The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 26 1997 Mr. Jerome D. Davis Managing Director Aurex Precious Metal Industries (PTY) LTD P.O. Box 509 Edenvale 1610 Republic of South Africa Re: K972939 Aurecast Bio 59PF Trade Name: Requlatory 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 registration, listing of devices, qood 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. ಕ್ಕೆ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as sec 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 Administration (FDA) will verify such assumptions. Failure to 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 diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 qeneral 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.ffla.gov/cdrh/dsmamain.html". Sincerely yours, Alidatist Timo 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):_____________________________________________________________________________________________________________________________________________________ 'evice Name: AURECAST BIO 59PF Indications For Use: Dental casting alloy for making dental restorations and appliances. SE WITH DENTAL PORCELAINS NI (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Susan Ruma (Division Sign-Off Division of Dental, it and General Hos 510(k) Number escription Use (21 CFR 801.109) Over-The-Counter Use