(23 days)
Vision Porcelain is used in fabrication of crowns Inlays, Veneers and bridges.
Not Found
I am sorry, but the provided text is a 510(k) clearance letter for "Vision Porcelain," which is a dental material used in the fabrication of crowns, inlays, veneers, and bridges. This document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory approval document confirming substantial equivalence to a predicate device.
Therefore, I cannot extract any of the requested information, such as:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or data provenance.
- Number and qualifications of experts.
- Adjudication methods.
- Results of multi-reader multi-case studies.
- Standalone algorithm performance.
- Type of ground truth used.
- Training set sample size or ground truth establishment.
{0}------------------------------------------------
Public Health Service
Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three abstract human profiles facing to the right, with flowing lines representing hair or head coverings.
2 1999 APR
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Angelika Rinehart Servo-Dental USA, Incorporated 1770 Birch Road 60062-5908 Northbrook, Illinois
Re : K990790 Vision Porcelain Trade Name: Requlatory Class: II Product Code: EIH Dated: March 8, 1999 March 10, 1999 Received:
Dear Ms. Rinehart
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 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 Existing major be subject to such additional controls. 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 through 542 of
{1}------------------------------------------------
Page 2 - Ms. Rinehart
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 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" (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,
Patroux Cucinattoffix
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}------------------------------------------------
510(k) Number (if known): UNKNOWN
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
Vision Porcelain is used in fabrication of crowns Inlays, Veneers and bridges.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Angela Blackwell for MSR
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K990790
Prescription Use V (Per 21 CFR 801.109) OR
Over-The-Counter Use
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.