(53 days)
Not Found
Not Found
No
The provided 510(k) summary describes a dental restorative material and does not mention any AI or ML components.
No
The intended use describes the restoration of cavities and defects, which are treatments for diseases or injuries. While this is a medical intervention, it does not fit the common understanding of a therapeutic device designed to cure, mitigate, treat, or prevent disease over time, but rather a restorative material.
No
The "Intended Use / Indications for Use" only describes restorative procedures (filling cavities, intermediary restorations), which are treatments, not diagnostics. There is no mention of identifying, detecting, or assessing a disease or condition.
Unknown
The provided 510(k) summary is incomplete and lacks a device description, making it impossible to determine if the device is software-only. The intended use describes dental restorations, which typically involve physical materials and procedures, suggesting a hardware component is likely involved, but this cannot be confirmed without a device description.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed (restoring cavities, intermediary restorations) are all procedures performed directly on a patient's teeth.
- Lack of IVD Characteristics: IVDs are used to examine specimens (like blood, urine, tissue) outside of the body to diagnose diseases or conditions. The provided description does not mention any such use or interaction with biological specimens.
The device appears to be a dental restorative material or system used for direct application in the mouth.
N/A
Intended Use / Indications for Use
- Restoration of Class V cavities (cervical caries, root erosion, wedge-shaped defects)
- Restorations in deciduous teeth
- Intermediary restorations
- Anterior Class III restorations
Product codes
EBF
Device Description
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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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.
0
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 stylized eagle with three lines representing its wings and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 30 1998
Mr. Peter P. Mancuso Quality Assurance/Regulatory Affairs Manager Ivoclar North America, Incorporated 175 Pineview Drive Amherst, New York 14228
K974577 Re : Compoglass Flow Trade Name: Regulatory Class: II Product Code: EBF December 2, 1997 Dated: Received: December 8, 1997
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 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 The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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. ಡಿ substantially equivalent determination assumes compliance with ... _ the current Good Manufacturing Practice requirement, 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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you miqht 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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 ene regaration Chororou, (21 CFR 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/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 Radioloqical Health
Enclosure
2
Page | 1 |
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of | 1 |
510(k) NUMBER (IF KNOWN): K974577
Compoglass Flow DEVICE NAME:
INDICATIONS FOR USE:
- Restoration of Class V cavities (cervical caries, root erosion, wedge-shaped defects)
- Restorations in deciduous teeth
- Intermediary restorations
- Anterior Class III restorations
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Supper of CDRH, Office of Device Evaluation (ODE) | |
---|---|
(Division Sign-Off) | |
Division of Dental, Infection Control, and General Hospital Devices | |
510(k) Number | K974577 |
Prescription Use | ✓ |
(Per 21 CFR 801.109) |
OR
Over-The-Counter-Use | |
---|---|
(Optional Format 1-2-96) |