(129 days)
Definite® is a light cured composite intended to be used for all classes of restorations from class I to class V.
Definite® is a light cured composite offered as a single paste system in compules. The system consists of the filling material Definite® and the self etching adhesive Etch&Prime® 3.0.
The provided FDA document (K993514) is a 510(k) clearance letter for a dental restorative material called "Definite®". It is a premarket notification, not a clinical study report. Therefore, it does not contain any information about acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.
The document only states that the device is "substantially equivalent" to legally marketed predicate devices for use in "all classes of restorations from class I to class V." This substantial equivalence determination is based on the comparison to predicate devices, not on a new clinical study detailed in this specific document.
To answer the requested questions, one would need access to the full 510(k) submission, which is typically not publicly available in this level of detail, or reference a separate clinical study report, if one was conducted and made public.
Therefore, based solely on the provided document, I cannot provide information for the following:
- A table of acceptance criteria and the reported device performance: Not present.
- Sample sizes used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method for the test set: Not present.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not present. This device is a dental restorative material, not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present. This device is a dental restorative material.
- The type of ground truth used: Not present.
- The sample size for the training set: Not present.
- How the ground truth for the training set was established: Not present.
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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 is circular and features the department's name around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 4 2000
Thomas B. Cameron, Ph.D. Official Correspondent Director of R&D and Q.A. Degussa-Ney Dental, Incorporated 65 West Dudley Town Road Bloomfield, Connecticut 06002-1316
Re : K993514 Definite® Trade Name: Regulatory Class: II Product Code: EBF January 4, 2000 Dated: Received: February 7, 2000
Dear Dr. Cameron:
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, Druq, 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 reqistration, 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 Regulations, Title 21, Parts 800 to 895. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP 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 concerning your device in
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Paqe 2 - Dr. Cameron
the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 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 beqin marketing your device as described in your 510 (k) premarket notification. The FDA findinq 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" (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 Radiological Health
Enclosure
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510(k) NUMBER K993514
DEVICE NAME: Definite
INDICATIONS FOR USE:
Definite® is a light cured composite intended to be used for all classes of restorations from class I to class V. Since Definite® is light cured, it is offered as a single paste system in compules. The system consists of the filling material Definite® and the self etching adhesive Etch&Prime® 3.0.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINTTE 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) | |
|---|---|
| ----------------------------------------------- | -- |
(Division Sign-Off) Pamela Scott for Susan Runner
Division of Dental, Infection Control, and General Hospital Devices
| 510(k) Number | K993514 |
|---|---|
| --------------- | --------- |
§ 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.