P10 SPECIAL

{0}------------------------------------------------ NOV 1 5 1999 K993344 H AMERICAN ALLOY Image /page/0/Picture/3 description: The image shows a black and white drawing of an eagle perched on a branch. The eagle is facing to the right and has its wings spread. The eagle's feathers are detailed, and its beak is open. The branch is also detailed, and it has leaves on it. The background is white. 225 Brentwood Ct. • Bloomingdale, IL 60108-2111 • 630-980-5618 ## 510(k) SUMMARY Trade name: "P10 Special" Alloy Common name: Base Metal Alloy Classification name: Base Metal Alloy (per 21 CFR 872.3710) P10 Special alloy is a cobalt based crown and bridge alloy containing chromium Device Description: and molybdenum. Intended use: The fabrication of a custom crown or bridge prosthesis by a dental laboratory. Predicate devices: Austenal "Advantage", Jeneric "RX Biocast" CMP "Vulcan" are Co-based crown and bridge alloys. Summary of Technological Characteristics: A comparison of compositional analysis indicates P10 Special and the predicate devices to be similar, with a total Co/Cr/Mo sum percentage of 89-94 %. A comparison of physical properties indicates P10 Special alloy is similar in yield strength to "Advantage". "P10 Special" has a higher yield strength but is not as hard as Vulcan. Vulcan exhibited somewhat higher % elongation. Performance testing by field laboratories indicated that P10 Special met or exceeded performance standards of traditional crown and bridge alloys being utilized. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines representing hair or clothing. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 NOV 1 5 1999 Ms. Kathleen Calero President North American Alloys, Inc. 225 Brentwood Ct. Bloomingdale, IL 60108-2111 Re : K993344 Trade Name: P10 Special Requlatory Class: II Product Code: EJH September 28, 1999 Dated: Received: October 5, 1999 Dear Ms. Calero: 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. ਜੋ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory 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 {2}------------------------------------------------ Page 2 - Ms. Calero obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations. 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 y A. Ulatows Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Page of of K 993344 510(k) Number (if known): _ P10 Special Device Name: ___ ... Indications For Use: For the fabrication of a custom crown or bridge prosthesis by a dental laboratory. It is to be offered as an alternative to nickel-based crown and bridge alloys for nickel sensitive patients, as well as for international markets which prefer cobalt-based alloys. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use_ (Optional Format 1-7-95) Suan Puan (Division Sign-Off) Division of Dental, It and General Hor 510(k) Number