AALBA GOLD SOLDER

{0}------------------------------------------------ Image /page/0/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 an eagle with its wings spread. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Vincent Benetti General Manager Aalba Dent, Incorporated · AUG 1 5 1997 400 Watt Drive Cordelia, California 94585 K972532 Re: "Yellow-Gold" Colored, Soldering Alloy Trade Name: Regulatory Class: II Product Code: EJT Dated: July 2, 1997 Received: July 7, 1997 Dear Mr. Benetti: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the marroo 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 requlations 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 Requlation (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 Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 {1}------------------------------------------------ Page 2 - Mr. Benetti through 542 of the Act for devices under the Electronic chrough 312 or on introl 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 marrees 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 Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health Enclosure {2}------------------------------------------------ Page_1_of_1_1_ K972532 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Aalba Gold Solder Device Name :_________________________________________________________________________________________________________________________________________________________________ Indications For Use: - - - ---- - This device is a "yellow-gold" colored, soldering alloy for use in the construction and repair of crown and bridge dental prosthetic devices. According to 21 CFR Ch. 1 (4-1-89 Ed.) Part 872. the classification name for this device is Gold Based Alloy and Precious Metal Alloys for Clinical Use, a Class II device. (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED. ) Concurrence of CDRH, Office of Device Evaluation (ODE) Suen Runner (Division Sion-Off Division of Dental. and General Hospita 5 1 O(k) Number ન્ડ Prescription Use OR (Per 21 CFR 801.109) Over-The Counter Use_NO (Optional Format 1-2-96)