AURELUX BIO Y85PF

{0}------------------------------------------------ K 972949 Image /page/0/Picture/1 description: The image shows the logo for AUREX. The logo consists of the word "AUREX" in bold, capital letters, with a stylized graphic above it. The graphic appears to be two overlapping triangles, creating a mountain-like shape. **P.O. Box 509 Edenvale 1610** **Republic of South Africa** **Telephone**: +27 (11) 609-8640 **Telefax**: +27 (11) 452-3918 2018-08-07 11:12:13:13 11:11:13 11:11:13 11:11:11:11 11:11:11 11:11:11 11:11:11 11:11:11 11:11:11 11:11:11 11:11:11 11:11:11 11:11:11 11:11:11 11:11:11 11:11:11 11:11:11 11: SEP 1 8 1997 ## 510 (k) Summary Trade name: Common name: Classification name: Class ification number: AURELUX Bio Y85PF Dental casting alloy Gold based alloys and precious metal alloys for clinical use EJT Legally marketed device: Argen Argedent Bio Yellow PF Description of the device: High gold casting alloy Intended use of the device: Type II to IV restoration with porcelain veneering ## Summary of the technological characteristics Test methods applied: as in ANSI/ADA 5 and ISO 9693 Comparison of composition: | ALLOY | | | COMPOSITION (weight%) | | | | | | | | |-------|-------------------|--|-----------------------|------|-----|-----|-----|-----|-----|-----| | | Name | | Au | Pt | Zn | Ta | In | Ir | Rh | Mr | | Legal | Argedent Bio Y PF | | 86.5 | 10.4 | 1.5 | 0.3 | 0.2 | 0 | 0.9 | 0.1 | | New | Aurelux BioY85PF | | 84.5 | 12 | 1.8 | 0 | 0.5 | 1.2 | 0 | 0 | x is less than 1 % Comparison of physical and mechanical properties | ALLOY | Melting point<br>range (oC) | Hardness<br>(Vickers<br>5/30) | Yield<br>strength<br>(MPa) | Elongation<br>(%) | CTE<br>( x10-<br>6/°C ) | Density<br>(g/cm3) | | | | | | |-------|-----------------------------|-------------------------------|----------------------------|-------------------|-------------------------|--------------------|------|------|---|------|------| | Name | solid. | liquid | soft | hard | soft | hard | soft | hard | | | | | Legal | Argedent B Y PF | 1040 | 1130 | 180 | 250 | 650 | 750 | 8 | 5 | 14.5 | 18.6 | | New | Aurelux | 1027 | 1079 | 120 | 220 | 280 | 460 | 17 | 7 | 14.4 | 18.8 | | | BioY85PF | | | | | | | | | | | ## Discussion The noble metal content is very high, in the excess of 98 %. Total base metal content is therefore very low, the major element of it in both alloys is Zn with 1.8 and 1.5 % respectively. Argedent contains also Ta and Mn, which most probably are oxidized and eliminated from the alloy during melting. ## Conclusion On the basis of the very high noble metal content and essentially same constitution it may be expected that the new alloy perform very similarly to Argident B Y PF. Image /page/0/Picture/22 description: The image shows a logo with the text "TUV CERT" in bold, black letters. The "TUV" is stacked on top of "CERT". The logo is enclosed in a rounded square border. There are two curved lines above the text, adding a design element to the logo. Aurex Precious Metal Industries (Pty) Limited (Reg.No. 88/04891/07) -13- {1}------------------------------------------------ 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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, graphic style. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP 1 8 1997 Mr. Jerome D. Davis Managing Director Aurex Precious Metal Industries (PTY) Ltd. P.O. Box 509 Edenvale 1610 Republic of South Africa Re : K972949 Aurexlux Bio Y85PF Trade Name: Requlatory Class: II Product Code: EJS 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, 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਚੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory In addition, FDA may publish further announcements action. 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) 594-4618. 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.fda.gov/cdrh/dsmamain.html". Sincerely yours, Patricia Cucenita ffor Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ <977 510(k) Number (if known):____ AURELUX BIO Y85PF Device Name: Indications For Use: Dental casting alloy used in combination with dental ceramics for fabrication of metallo-ceramic restoration. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Gerald Skinner Division of and 510(k) Number K972949 Prescription Use or 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)