(32 days)
For use in the Fabrication of Porcelain-Fused-to-Metal Dental Crowns and Bridges.
Not Found
The provided documents are a 510(k) premarket notification letter from the FDA regarding a dental device called "V-Delta 450" and its indications for use. This type of document does not contain information about acceptance criteria or a study proving the device meets said criteria.
Therefore, I cannot provide the requested information. The documents primarily confirm the substantial equivalence of the device to a predicate device and approve its marketing, outlining regulatory compliance requirements.
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Image /page/0/Picture/2 description: The image contains the words "Food and Drug". The text is centered horizontally. There is a horizontal line above the text.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Ken Putney Official Correspondent Metalor Dental USA Corporation 255 John L. Dietsch Boulevard North Attleborough, Massachusetts 02761
AUG 1 8 1997 ...
K972683 Re: Trade Name: V-Delta 450 Requlatory Class: II Product Code: EJS Dated: July 15, 1997 Received: July 17, 1997
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 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 Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Erug 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. 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 - Mr. Putney
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 labelinq 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,
Thy Wildrust
Timothy Wildrust
r A. 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): | K972683 |
|---|---|
| Device Name: | V-Delta 450 |
| Indications For Use: |
For use in the Fabrication of Porcelain-Fused-to-Metal Dental
Crowns and Bridges.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
| 510(k) Number | K972683 |
|---|---|
| --------------- | --------- |
| Prescription use | OR | Over-The-Counter Use | |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
Page 4-3 (revised)
§ 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.