(26 days)
Not Found
No
The summary describes a dental composite material and does not mention any AI or ML components or functionalities.
No.
The device is a composite material used for dental core build-up, which is a restorative dental procedure, not a therapeutic one.
No
Explanation: The device is a core build-up composite, which is a dental material used for restorative purposes, not for diagnosing medical conditions.
No
The device description clearly states it is a "composite," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is "Core Build-up Composite for use with a 4th or 5th generation adhesive system." This describes a material used in dental procedures to build up tooth structure, not to perform diagnostic testing on biological samples.
- Device Description: The description confirms it's a "translucent, fiber-reinforced, light-cured core build-up composite." This further reinforces its use as a dental restorative material.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely restorative in a dental context.
N/A
Intended Use / Indications for Use
Core build-up composite for use with a 4th or 5th generation adhesive system.
Product codes
EBF
Device Description
Light-Core is a translucent, fiber-reinforced, light-cured core build-up composite for use with a 4th or 5th generation adhesive system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
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)
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
NOV 1 0 1999
Attachment 5 - 510(k) Summary
-
- Bisco, Inc. 1100 W. Irving Park Road Schaumburg, IL 60193 847-534-6000 Contact: Kathryn B. Patterson, Regulatory Affairs Manager Date Prepared: October 14, 1999
| 2. Device Trade Name: | Light-Core™ |
|---|---|
| Common/Usual Name: | Translucent Core Build-up Composite |
| Classification Name: | Filling Material |
-
- Predicate Device: Kuraray's Photo Core, K882006 (cleared June 13, 1988)
- Light-Core is a translucent, fiber-reinforced, light-cured core build-up composite for use with 4. a 4th or 5th generation adhesive system.
-
- The intended use of Light-Core is:
- Core build-up composite for use with a 4th or 5th generation adhesive system. .
-
- Light-Core possesses the same technological characteristics as the predicate device, Clearfil Photo Core. Below is a table which shows a side-by-side comparison of the technological characteristics of Light-Core and Clearfil Photo Core.
| Characteristic | Light-Core | Clearfil Photo Core |
|---|---|---|
| Intended Use | Restoration where | |
| light-curing composite | ||
| for core build-up is | ||
| required. | Restoration where | |
| light-curing composite | ||
| for core build-up is | ||
| required. | ||
| Chemical Composition | Light-cured | Light-cured |
| Physical/Mechanical Properties | High flexural, | |
| compressive and | ||
| tensile strengths. | ||
| Flexural modulus | ||
| similar to dentin. | High flexural, | |
| compressive and | ||
| tensile strengths. | ||
| Flexural modulus | ||
| similar to dentin. | ||
| Biocompatibility | Non-toxic | Non-toxic |
| Depth of Cure | High | High |
| Physical Description | Light-cured, high- | |
| viscosity, translucent | ||
| composite. | Light-cured, high- | |
| viscosity, translucent | ||
| composite. | ||
| Handling Time (post-dispensing) | 5 minutes | 5 minutes |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a bird in flight, composed of flowing lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 0 1999
Ms. Kathryn B. Patterson Regulatory Affairs Manager Bisco, Inc. 1100 W. Irving Park Road Schaumburg, IL 60193
K993488 Re :
Light-Core™ (Translucent Core Build-up Trade Name: Composite) Requlatory Class: II Product Code: EBF Dated: October 14, 1999 Received: October 15, 1999
Dear Ms. Patterson:
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 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. ਕੇ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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
2
Page 2 - Ms. Patterson
the Federal Register. Please note: this response to your premarket notification submission does not affect any prematice noou might have under sections 531 through 542 of obligation you might the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as inis receir will areas () premarket notification. The FDA acborized substantial equivalence of your device to a legally rinding of bubbeansear of a classification for your markets probus, 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 yitro 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 che 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.fdag.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Attachment 2 - Indications for Use
Indications for Use 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ Device Name:__________________________________________________________________________________________________________________________________________________________________ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Indications for Use:
- Core Build-up Composite for use with a 4th or 5th generation adhesive system. .
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| Use | |
| (Per 21 CFR 801.109) |
OR
| Over-the-Counter | |
|---|---|
| (Optional Format 1-2-96) |
Susar Runner(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Dev 510(k) Number _