(32 days)
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No
The provided text does not contain any keywords or descriptions related to AI or ML technology.
No
The provided text describes D-Sign III's indications for use with dental prosthetics and materials (feldpathic porcelains, 3/4 crowns, telescop crowns, conus crowns, posts, attachments, short and long span bridges, PFM crowns). There is no information suggesting it is used for treatment, diagnosis, or prevention of disease.
No
The "Indications for Use" describes the D-Sign III as being used with dental materials and for various types of dental prostheses (crowns, bridges, etc.), which points to it being a dental material or fabrication related device, not a diagnostic one. There is no mention of identifying, detecting, or measuring a disease, condition, or physiological state.
No
The provided text describes a dental material (feldpathic porcelains) and its applications in dental prosthetics (crowns, bridges, etc.). There is no mention of software, hardware, or any digital component.
Based on the provided information, it is highly unlikely that this device is an IVD (In Vitro Diagnostic).
Here's why:
- Indications for Use: The indications describe the use of the device with dental materials (feldspathic porcelains) and for creating various dental prosthetics (crowns, bridges, posts, attachments). This points towards a device used in the fabrication of dental restorations, which is not the typical domain of IVDs.
- Lack of IVD-related information: The provided text lacks any mention of:
- Analyzing biological samples: IVDs are used to examine specimens taken from the human body (blood, urine, tissue, etc.).
- Diagnosing diseases or conditions: IVDs provide information used for diagnosis, monitoring, or screening.
- Specific analytes or biomarkers: IVDs typically measure or detect specific substances in biological samples.
- Laboratory settings: While some IVDs are used in point-of-care settings, many are used in clinical laboratories.
The description strongly suggests a device used in a dental laboratory or clinic for the creation of dental prosthetics.
Therefore, based solely on the provided text, D-Sign III does not appear to be an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Indications for Use: D-Sign III is to be used with conventional feldpathic porcelains. Also recommended for 3/4 crowns, telescop crowns, conus crowns, posts, attachments, short and long span bridges, PFM crowns.
Product codes
EJS
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
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
Re: K990077 D-Sign III (R&D Project DW264 #7) Trade Name: Requlatory Class: II Product Code: EJS Dated: January 6, 1999 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 Existing major be subject to such additional controls. requlations 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 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" (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/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
K990077
Page 1 of 1
510(k) Number (if known): K99007-
Sign 11 Device Name: 0
Indications For Use:
Indications for Use: D-Sign III is to be used with conventional feldpathic porcelains. Also recommended for 3/4 crowns, telescop crowns, conus crowns, posts, attachments, short and long span bridges, PFM crowns.
(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 Runn
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number