(35 days)
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No
The provided text does not contain any mention of AI, ML, or related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses solely on the intended use with dental materials and restorations.
No
The indications for use describe dental applications for crowns and bridges, which are restorative rather than therapeutic.
No
The provided text for "Indications for Use" describes D-Sign as being used with dental materials and for various types of dental restorations (crowns, bridges). This suggests it is a material or component used in the creation of dental prosthetics, not a device used to diagnose a medical condition or disease.
No
The provided text only describes the intended use of a dental material (feldspathic porcelains) and its applications in dental restorations. There is no mention of software, hardware, or any other component that would constitute a medical device, let alone a software-only one.
Based on the provided information, it is highly unlikely that this device, "D-Sign," is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device's application in dental restorations (crowns, bridges, etc.) using conventional feldspathic porcelains. This is a direct application within the body or for creating devices that will be placed in the body, not for testing samples taken from the body.
- Lack of IVD Characteristics: The description lacks any mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information about a patient's health status based on sample analysis
- Any laboratory or clinical testing context
Conclusion:
The provided information strongly suggests that D-Sign is a material or component used in the fabrication of dental prosthetics, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / 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 porceration indo roomments, 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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 9 1999
Peter P. Mancuso Mr. Quality Assurance/Regulatory Affairs Manager Ivoclar North America, Incorporated 175 Pineview Drive Amherst, New York 14228
Re : K984451 D-Sign I (R&D Project DW263 #24) Trade Name: Regulatory Class: II Product Code: EJS December 14, 1998 Dated: December 15, 1998 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 The general controls controls provisions of the Act. 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਚ 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 Reqister. 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 regulations.
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 regulation (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 general 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
| CONFIDENTIAL | |
|---|---|
| 510(k) Number (if known): | K984451 |
Device Name: D- Sign I
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 porceration indo roomments, short and long span bridges, PFM crowns.
Image /page/2/Picture/5 description: The image contains two Japanese characters. The first character is "の" (no), which is a hiragana character. The second character is "お" (o), which is also a hiragana character. Hiragana is a Japanese syllabary, one component of the Japanese writing system.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ سن (Per 21 CFR 801.109) ભ
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Susan Runner
(Division Sign-Off) Division of Dental. Infection Control, and General Hospital Devices 510(k) Number ા (C