PALCERAM 56

{0}------------------------------------------------ SEP 1997 Image /page/0/Picture/1 description: The image shows a logo with a stylized mountain range above the word "AUREX". The mountain range is composed of three overlapping triangles, creating a sense of depth and complexity. The word "AUREX" is written in a bold, sans-serif font, with a horizontal line underlining the text. P.O. Box 509 Edenvale 1610 Republic of South Africa Telephone : +27 (11) 609-8640 Telefax : +27 (11) 452-3918 -19- K972955 ## 510 (k) Summary Trade name: Common name: Classification name: Class ification number: EJT PALCERAM 56 Dental casting alloy Gold based alloys and precious metal alloys for clinical use Legally marketed device: Aurium Aurolite IK Description of the device: Palladium silver based casting alloy Intended use of the device: Type 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 | Ag | Pd | Sn | In | Zn | Ru | | Legal | Aurolite IK | 30 | 58 | 6 | 4 | x | x | | New | Palceram 56 | 32 | 56.5 | 3.9 | 7.3 | 0 | 0.3 | x is less than 1 % Comparison of physical and mechanical properties | ALLOY | | Melting point range (oC) | | Hardness (Vickers 5/30) | | Yield strength (MPa) | | Elongation (%) | | CTE (x10-6/oC) | Density (g/cm3) | |-------|-------------|--------------------------|--------|-------------------------|------|----------------------|------|----------------|------|----------------|-----------------| | | Name | solid. | liquid | soft | hard | soft | hard | soft | hard | | | | Legal | Aurolite IK | 1232 | 1282 | 260 | | 552 | | 14 | | 14.9 | 11.3 | | New | Palceram 56 | 1200 | 1230 | 200 | 265 | 470 | 600 | 8 | 3 | 14.9 | 11.1 | ## Discussion The same constituents can be found in both alloys save a minor concentration of Fe vs. Zn. ## Conclusion Identical main elements and the similarity of their content can result in similar chemical and biological effect. Image /page/0/Picture/20 description: The image shows a logo with the text "TUV CERT" stacked on top of each other. The logo is enclosed in a rounded square. The text is in a bold, sans-serif font. The logo is black and white. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP - 5 1997 Mr. Jerome D. Davis Managing Director Aurex Precious Metal Industries (PTY) Ltd. P.O. Box 509 Edenvale 1610 Republic of South Africa K972955 Re : Palceram 56 Trade Name: Regulatory Class: II Product Code: EJT June 13, 1997 Dated: 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 able beated in the enouble 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 regulations 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 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 regulatory 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 ma 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 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 Timot U 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: 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) Susan Simmons (Division Sion-GM 510 Prescription Use Per 21 CFR 801.109) OR Over-The-Counter Use (Optional Format 1-2-96)