(40 days)
Indications for Use: D-Sign V is to be used with conventional feldpathic porcelains. Also recommended for posts, attachments, short and long span bridges, and PFM crowns.
Not Found
This document is a 510(k) clearance letter from the FDA for the D-Sign V device. It does not contain information about acceptance criteria or a study proving device performance.
The letter confirms that the FDA has reviewed the 510(k) notification and determined the device is substantially equivalent to legally marketed predicate devices. It grants permission to market the device, subject to general controls provisions of the Act.
Therefore, I cannot provide the requested information based on the provided text. The document focuses on regulatory clearance and substantial equivalence, not on specific performance study details or acceptance criteria.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three wing-like strokes. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 1 1999
Mr. Peter P. Mancuso Quality Assurance/Regulatory Affairs Manager Ivoclar North America, Incorporated 175 Pineview Drive Amherst, New York 14228
Re : K990182 D-Sign V (R&D Project DW267 #17) Trade Name: Requlatory Class: II Product Code: EJH January 15, 1999 Dated: Received: January 20, 1999
Dear Mr. Mancuso:
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 reqistration, 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 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 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 obliqation you might have under sections 531
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Page 2 - Mr. Mancuso
through 542 of the Act for devices under the Electronic chrough 342 or cho iso al provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as Inis icceci will areas) ( premarket notification. The FDA described in your sia my pour device of your device to a legally Finding of Bubbeaneral ogaresults in a classification for your marketed predicate device robated 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 regulation (sic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on compreator as (no advertising of your device, please contact the Diomotion and adversions (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to Other general premarket notification" (21CFR 807.97). information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance obeatied from one (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
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): | K990182 |
|---|---|
| --------------------------- | --------- |
Device Name:_______________________________________________________________________________________________
Indications For Use:
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Indications for Use: D-Sign V is to be used with conventional feldpathic porcelains. Also recommended for posts, attachments, short and long span bridges, and PFM crowns.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Y (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
:
Susan Runns
(Optional Format 1-2-96)
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 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.