(32 days)
Indications for Use: D-Sign is to be used with conventional feldpathic porcelains. Also recommended for 3/4 crowns, telescop crowns, conus porcerains. Inco recoments, short and long span bridges, PFM crowns.
Not Found
This document is a 510(k) clearance letter from the FDA for a dental device called "D-Sign IV". The letter states that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or specifics about ground truth for training or testing sets. These details are typically found in the substantial equivalence report or technical documentation submitted with the 510(k) application, not in the clearance letter itself.
Therefore, I cannot provide the requested information based on the given input. The document confirms market clearance based on substantial equivalence, but it does not detail the technical study results or performance metrics.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 1999
Mr. Peter P. Mancuso Quality Assurance/Regulatory Affairs Manager Ivoclar North America, Incorporated 175 Pineview Drive Amherst, New York 14228
K990078 Re : D-Sign IV (R&D Project DW265 #37) Trade Name: Requlatory Class: II Product Code: ETS January 8, 1999 Dated: Received: January 11, 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 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. ਸ 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 obligation you might have under sections 531
{1}------------------------------------------------
Page 2 - Mr. Mancuso
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 comprease as (on 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" (21CFR 807.97). Other qeneral 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/dsmamajn.html".
Sincerely yours,
Timothy A. Ulatowski
Direčtor Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Page _ of _
510(k) Number (if known): K990078
Device Name:_ C
Indications For Use:
Indications for Use: D-Sign is to be used with conventional feldpathic porcelains. Also recommended for 3/4 crowns, telescop crowns, conus porcerains. Inco recoments, short and long span bridges, PFM crowns.
Image /page/2/Picture/13 description: The image contains two shapes, a square and a circle, both filled with black. The square is on the left side of the image and has a textured or grainy appearance. The circle is on the right side of the image and appears to be solid black. The background of the image is white.
(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)
Susan Rapps
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital 510(k) Number.
§ 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.