CONCORD 72

{0}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three curved lines that resemble a human figure or a bird in flight. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL 1 6 2001 Mr. John C. Constantine Secretary/Treasurer Gateway Alloys, Incorporated 1702 Scherer Parkway 63303 Saint Charles, Missouri Re : K011626 Concord 72 Trade/Device Name: 872.3060 Regulation Number: Regulatory Class: II EJT Product Code: May 29, 2001 Dated: May 29, 2001 Received: ## Dear Mr. Constantine: We have reviewed your Section 510(k) notification of intent to we have reviewed your beooed above and we have determined the market the device ferences as a substant (for the indications for device is bubbeancearly sure) to legally marketed predicate use stated in the cholobare, e commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to the enactment accordings first in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). provisions of the reactar rood bray, and early the general controls provisions of the Act. The general controls concrois provisions of include requirements for annual provisions of the not of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II II your device ID crabins III (Premarket Approval), it may be subject to such additional controls. Existing major be subject to Bacting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. .A rederal Acguiderence, Iroso termination assumes compliance with subscancially equiralfacturing Practice requirements, as set the Current Sood hands System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug chrough periodio go mapl verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. {1}------------------------------------------------ ## Page 2 – Mr. Constantine concerning your device in the Eederal Register. Please note: concerning your device in arrantet notification submission does this response to your premaries now under sections 531 not arrect any obingation of the Electronic through 542 of the net roll control or other Federal laws or requlations. This letter will allow you to begin marketing your device as Infs receir wiri allo(k) premarket notification. The FDA described in your 510 k, premaines of your device to a legally finding of substantial equivalence of your device for your finding of substancial equivalence or your the morey marketed predicate device rebares in market. If you desire specific advice for your device on our labeling II you desire specific additionally 809.10 for in regulation (21 cm Fare over and se contact the Office of Villo diagnostic devices), proubedily, for questions on Compilance at (501) beertising of your device, please contact the promotion and adversibility on John March please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general premation on your responsibilities under the Act may be Information on your responsible of Small Manufacturers Assistance obtained from the bivision or billian (801) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html". Sincerely yours, Klatouski Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## 626 バ (510 (k) Number: _____________________________________________________________________________________________________________________________________________________________ Device Name: _ CQNCORD 72 Indications for Use: CONCORD 72 (PM-41) is a yellow colored gold/platinum dental casting alloy for restorations subject to high stress and that require low fusing porcelain enamels be fused to some of the surfaces. It may also be used as a Type IV (Extra Hard) crown and bridge alloy. It is intended for use in the manufacture of single units, % crowns, and short-span and long-span bridgework. (Please do not write below this line) Supr. Purse (Division Sign-Off) Division of Dental, Infection Control, ാർ General Hospital Devices ド:行火) Number __ Prescription Use (Per 21 CFR 801.109 OR Over-the-Counter-Use ----