(53 days)
- Restoration of Class V cavities (cervical caries, root erosion, wedge-shaped defects)
- Restorations in deciduous teeth
- Intermediary restorations
- Anterior Class III restorations
Not Found
The provided document is a 510(k) clearance letter from the FDA for a dental material called "Compoglass Flow." This type of document does not contain the detailed study information required to answer your questions about acceptance criteria and device performance.
510(k) clearances establish substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device. They typically rely on a comparison of characteristics and, sometimes, limited performance testing results to demonstrate that equivalence. They do not generally include comprehensive clinical trial data, detailed acceptance criteria for performance metrics, or information about ground truth establishment, sample sizes for training/test sets, or detailed expert qualifications that would be present in a clinical study report or a premarket approval (PMA) application.
Therefore, I cannot provide the requested information based on the given text.
To answer your request, I would need a detailed study report or a PMA application for the device, which would typically include:
- A clinical study protocol: Outlining the study design, endpoints, statistical analysis plan, and acceptance criteria.
- Clinical study report: Presenting the results of the study against the established acceptance criteria.
- Bench testing data: For certain performance characteristics.
- Ground truth establishment details: How the "truth" was determined for the performance evaluation.
Based on the available information, I can only state the following:
- Device Name: Compoglass Flow
- 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
- Regulatory Class: II
The document essentially states that the FDA has determined the device is "substantially equivalent" to predicate devices for these indications, implying that its performance is considered acceptable relative to legally marketed devices. However, the specific performance metrics and their acceptance criteria are not detailed in this clearance letter.
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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 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
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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
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| Page | 1 |
|---|---|
| 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) |
§ 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.