ORION WX DENTAL ALLOY

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's name encircling a stylized symbol. The symbol consists of three abstract human profiles facing right, with flowing lines beneath them, representing the department's mission to protect the health of all Americans and provide essential human services. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY | 8 1998 Mr. Michael H. Everngam ·President European Dental Imports, Incorporated 49 Emerson Road Durham, New Hampshire 03824-0799 Re : K981002 Orion WX Dental Alloy Trade Name: Regulatory Class: II Product Code: EJS Dated: March 9, 1998 Received: March 18, 1998 Dear Mr. Everngam: 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 legally marketed predicate 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 of the Act. The general controls provisions 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. Inc 2001 substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 regulation 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 {1}------------------------------------------------ Page 2 - Mr. Everngam 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 leqally 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 regulation (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"(21CFR 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/dsma/dsmamain.html". Sincerely yours, Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health Enclosure {2}------------------------------------------------ 510(k) Premarket Notification for Orion WX Dental Alloy Submitted by european dental imports, inc., Reg#1218814 INDICATIONS FOR USE: 510(K) Number: K981002 Device Name: Orion WX Dental Alloy Indications for Use: Used by a dental lab technician, under the direction of an attending dentist, to cast elements of fixed and removable dental prostheses: precious metal inlays, onlays, and crowns; precious metal bridges, bars, and attachments; precious metal copings and bridges for porcelain-fusedto-metal restorations. Orion WX is recommended for use with any normal-fusingtemperature porcelain product in porcelain-fused-to-metal restorations of from one crown up to a full-span bridge. After fabrication and finishing the completed prosthesis is approved and placed in the patient's mouth by the dentist. (Please do not write below this line) ****************************************************************************************************************************************************************************** Concurrence of CDRH, Office of Device Evaluation | Prescription Use | <span></span> | |----------------------|---------------| | (Per 21 CFR 801.109) | <span></span> | Over the Counter Use Susan Russe OR ivision Sign-Off) Division of Dental, Infection Control, and General Hospit 510(k) Number రు