(77 days)
d-Sign 84 is intended to be used with conventional feldpathic porcelains. Also a-olgh 04 intended to be assa mas, conus crowns, conus crowns, posts, attachments, short and long span bridges, and PFM crowns.
Not Found
The provided text is a 510(k) premarket notification approval letter for a dental alloy, D.SIGN 84. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML device, a diagnostic device, or any device that would have measurable performance characteristics like sensitivity, specificity, or accuracy against ground truth.
Therefore, I cannot extract the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, not on specific performance metrics or clinical study results as you would expect for the type of questions asked.
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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 consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird with three curved lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 2 2002
Mr. Andrejeet S. Gulati Quality Assurance Manager Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228
Re: K014042
Trade/Device Name: D. Sign 84 Regulation Number: 872.3060 Regulation Name: Gold-based Alloys and Precious Metal Alloys for Clinic Use Regulatory Class: II Product Code: EJS Dated: December 4, 2001 Received: December 7, 2001
Dear Mr. Gulati:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements
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Page 2 - Mr. Gulati
of the Act or any Federal statutes and regulations administered by other Federal agencies. or the rice or ally a vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and of Compliance week, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
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| K614042 |
|---|
| Not yet assigned |
510(k) Number (if known):
Device Name:
d. SIGN 84 (R&D Project # DW 215#13)
Indications For Use:
d-Sign 84 is intended to be used with conventional feldpathic porcelains. Also a-olgh 04 intended to be assa mas, conus crowns, conus crowns, posts, attachments, short and long span bridges, and PFM crowns.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
OR
Prescription Use Y (Per 21 CFR 801.109) Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Susan Quinn
(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.