(54 days)
Fabrication of Porcelain-Fused-to-Metal Dental Crowns, Bridges, and Implant-supported Prosthesis Substructures.
Not Found
The provided text is an FDA 510(k) clearance letter for a dental alloy, V-Delta Special, indicating its substantial equivalence to a predicate device. This type of document does not contain the detailed study information or acceptance criteria requested in your prompt.
The 510(k) clearance process primarily focuses on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics as the predicate, or if it has different technological characteristics, that it does not raise different questions of safety and effectiveness. It typically relies on comparisons to existing devices and performance testing (which may or may not be detailed in the public summary).
Therefore, I cannot provide the information you requested based solely on the text provided. To answer your questions, I would need a different type of document, such as a clinical study report, a comprehensive premarket notification summary (510(k) summary), or an equivalent regulatory submission that details device performance and study methodology for a medical device that has undergone extensive testing.
In summary, the provided document does not contain the information needed to answer your questions regarding acceptance criteria, study details, ground truth, or expert involvement.
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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC = 8 1999
Mr. Kenneth A. Putney Vice President, General Manager Official Correspondent Metalor Dental USA Corporation 255 John L. Dietsch Boulevard, P.O. Box 255 North Attleborough, Massachusetts 02761-0255
Re: K993505 V-Delta Special Trade Name: Regulatory Class: II EJS Product Code: October 11, 1999 Dated: Received: October 15, 1999
Dear Mr. Putney:
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 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಗಿ 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 requlation may result in requlatory 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
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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 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 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" (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.qov/cdrh/dsmamain.html".
Sincerely yours,
Timothy R. Ulatowski
Timoth y A. Ulatowski Directbr 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):_
V-Delta Special Device Name:
Indications For Use:
Fabrication of Porcelain-Fused-to-Metal Dental Crowns, Bridges, and Implant-supported Prosthesis Substructures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription use (Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
Page_
of
Susan Runno
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_
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§ 872.3060 Noble metal alloy.
(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are 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.