(2 days)
Titanium Porcelain is used for the veneering of artificial teeth for fixed prothesis in titanium crowns, bridges and dental implant abutments. These devices are used in prosthetic dentistry by forming a porcelain veneer on to the titanium coping into the shape of a dental crown.
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I am sorry, but the provided text is a letter from the FDA regarding a 510(k) premarket notification for a dental product called "Vita Titanium Porcelain." This document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria in the context of imaging or AI devices, which is what your query seems tailored for.
The letter is a regulatory approval document confirming substantial equivalence to a predicate device and outlines general regulatory information for the device's manufacturer. It does not include:
- A table of acceptance criteria or reported device performance.
- Details about a test set, data provenance, or sample sizes.
- Information on experts for ground truth establishment or adjudication methods.
- Any mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or human reader improvement with AI.
- Information about standalone algorithm performance.
- The type of ground truth used for a study.
- Training set sample sizes or how training ground truth was established.
Therefore, I cannot fulfill your request with the input provided.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem that features a stylized caduceus, which is a symbol of medicine and health. The caduceus is composed of three intertwined figures that resemble human profiles and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 1998 SEP
Ms. Barbara J. Lewandowski Regulatory Affairs Specialist Vident, Incorporated 3150 East Birch Street Brea, California 92821-6250
Re : K982664 Vita Titanium Porcelain Trade Name: Requlatory Class: II Product Code: EIH Dated: July 23, 1998 Received: July 30, 1998
Dear Ms. Lewandowski:
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 Requlations, Title 21, Parts 800 to 895. ਸੈ 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 requlation 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
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Page 2 - Ms. Lewandowski
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 requlation 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,
S. Dutman for
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510 (k) Number (if known): K982664
Device Name: Vita Titanium Porcelain
Indications For Use:
Titanium Porcelain is used for the veneering of artificial teeth for fixed prothesis in titanium crowns, bridges and dental implant abutments. These devices are used in prosthetic dentistry by forming a porcelain veneer on to the titanium coping into the shape of a dental crown.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runoe
(Division Sign-Off) Division of Dental, Infection Control and General Hospital Devices
510(k) Number _ 1980166
Prescription Use 11 (Per 21 CFR 801.109)
OR
Over-The Counter Use
(Optional Format 1-2-96)
§ 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.