NPG + 2

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked one behind the other. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Vincent Benetti General Manager Aalba Dent, Incorporation 400 Watt Drive Cordelia, California 94585 JAN - 5 1998 K972971 Re : NPG + 2 Trade Name: Requlatory Class: II Product Code: EJH Dated: November 18, 1997 November 21, 1997 Received: Dear Mr. Benetti: 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 abe beated in the 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 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 regulation may result in regulatory 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 obligation you might have under sections 531 {1}------------------------------------------------ Page 2 - Mr. Benetti through 542 of the Act for devices under the Electronic enroduct Radiation Control provisions, or other Federal laws or requlations. This letter will allow you to begin marketing your device as Info receir wir as 10 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 regulation (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 Timothy A. Ulatows Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 510(k) Number (if known): ___K972971 NPG+2 Device Name:__________________________________________________________________________________________________________________________________________________________________ Indications For Use: . ( This device is a nonprecious, copper-aluminum (plus gold) based casting alloy for use in the construction of cast dental crown and bridge prosthetic devices, such as fullmetal-coverage (FMC) crowns and bridgework, inlays/onlays, posts and cores, and metal sub-structures for polymer crown and bridge resins. According to 21 CFR Ch.1 (4-1-89 Ed.) Part 872. the classification name for this device is Base Metal Alloy, 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) Herold Skipper (Division Sign-Off) Division of Dental, In and General Hospital D F " "Jik) Number | Prescription Use | <div style="text-align: left;">✓</div> | |----------------------|----------------------------------------| | (Per 21 CFR 801.109) | OR | Over-The Counter Use__________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)