(129 days)
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No
The summary describes a dental composite material and adhesive, with no mention of AI or ML capabilities.
No
The device is a light-cured composite for dental restorations, which is a material used for treatment rather than a device that delivers therapy.
No
The device, Definite®, is described as a light-cured composite for dental restorations, which is a therapeutic material, not a diagnostic tool.
No
The device description clearly states it is a "light cured composite" and a "single paste system in compules," which are physical materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for dental restorations (filling cavities). This is a direct treatment applied to the patient's body.
- Device Description: The device is a composite material and adhesive used for filling teeth. This is a material used in a clinical procedure.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information
- Being used in a laboratory setting for testing
IVDs are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a therapeutic material used directly on the patient.
N/A
Intended Use / 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.
Product codes
EBF
Device Description
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.
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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§ 872.3690 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.
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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
1
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 |
|---|---|
| --------------- | --------- |