(60 days)
Supremcast Alloy is a Dental Ceramic Casting Alloy. For use in dental laboratories. Suitable for use in fabrication of ceramic fused to metal Dental restoration.
Supremcast Alloy is a Dental Ceramic Casting Alloy.
I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental alloy named "Supremcast." It confirms the device's substantial equivalence to legally marketed predicate devices and allows it to be marketed.
However, the letter does not contain any information about acceptance criteria, device performance, study details, sample sizes, ground truth establishment, or expert qualifications. Therefore, I cannot extract the requested information to fill out the table and answer the specific questions about a device study.
The document is purely a regulatory approval letter and does not include the technical study details that would typically be found in a clinical trial report or a scientific publication.
{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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure, composed of three curved lines that suggest wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 3 2001
Mr. Vachakan H. Khoie President American Dent-All Incorporated 5140 San Fernando Road Glendale, California 91204
Re : K011705 Trade/Device Name: Supremcast Requlation Number: 872.3710 Requlatory Class: II Product Code: EJH Dated: June 1, 2001 Received: June 4, 2001
Dear Mr. Khoie:
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 leqally 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 qeneral 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 regulation may result in regulatory In addition, FDA may publish further announcements action.
{1}------------------------------------------------
Page 2 - Mr. Khoie
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 through 542 of the Act for devices under the Electronic Product Radiation Control 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 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" (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 Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image is a low-resolution black and white image. The image appears to be a logo or emblem, but the details are difficult to discern due to the poor image quality. There are some vertical lines and curved shapes that may be part of a design or text, but they are not clear enough to read.
Indication for Use:
Device Name: Supremcast
Supremcast Alloy is a Dental Ceramic Casting Alloy. For use in dental laboratories. Suitable for use in fabrication of ceramic fused to metal Dental restoration.
Shira Parn
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devic 510(k) Number
§ 872.3710 Base metal alloy.
(a)
Identification. A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.