(35 days)
Not Found
Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
No
The device description mentions its use with feldspathic porcelains, posts, attachments, bridges, and PFM crowns, which are related to dental prosthetics, not therapeutic treatment of a health condition.
No
The description states 'D-Sign VI is to be used with conventional feldpathic porcelains' and is recommended for prosthetics like 'posts, attachments, short and long span bridges, and PFM crowns', indicating a device for manufacturing or processing dental restorations, not for diagnosing medical conditions.
No
The provided text describes a material (D-Sign VI) used with dental porcelains and restorations, which is a physical component, not software.
Based on the provided information, it is highly unlikely that D-Sign VI is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use describes the application of D-Sign VI with dental materials (feldspathic porcelains, posts, attachments, bridges, crowns). This is related to the fabrication or restoration of dental prosthetics, which is a dental device application, not an in vitro diagnostic test.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes (proteins, genes, antibodies, etc.)
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on in vitro testing.
- Missing Information: While the "Not Found" entries are not definitive proof, the absence of information about performance studies, key metrics (sensitivity, specificity), and training/test sets further suggests it's not an IVD, as these are crucial for demonstrating the analytical and clinical performance of an IVD.
In summary, the intended use clearly points towards a dental material or component used in the fabrication of dental prosthetics, which falls under the category of a dental device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
D-Sign VI is to be used with conventional feldpathic porcelains. Also recommended for posts, attachments, short and long span bridges, and PFM crowns.
Product codes
EJH
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an abstract symbol resembling an eagle or bird with stylized wings.
Public Health Service
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
K990235 Re : D-Sign VI (R&D Project DW266 #9) Trade Name: Requlatory Class: II Product Code: EJH Dated: January 14, 1999 January 25, 1999 Received:
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. ನ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements Please note: concerning your device in the Federal Register. 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 the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). 1 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/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
2
Image /page/2/Picture/0 description: The image shows a sequence of numbers and letters, specifically 'K990235'. Below this sequence, the text 'Page 1 of 1' is visible, indicating it might be a page number or a similar identifier within a document. The text and numbers are printed in a bold, somewhat distressed font, giving the image a slightly aged or copied appearance. The overall composition suggests the image is a snippet from a document, possibly a serial number or a page marker.
510(k) Number (if known): K990235
Device Name:
Indications For Use:
,
Indications for Use: D-Sign VI is to be used with conventional feldpathic porcelains. Also recommended for posts, attachments, short and long span bridges, and PFM crowns.
1997
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Usey (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
world Spear (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number_