(83 days)
Not Found
None
No
The summary describes a dental bonding agent and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
No
The device is used for conditioning enamel and dentin to obtain adhesive bonding, which is a preparatory step for restorative procedures, not a direct therapeutic action that treats or prevents a disease or condition.
No
Explanation: The device is described as conditioning enamel and dentin for adhesive bonding of polymeric materials. This is a therapeutic or preparatory function, not a diagnostic one.
No
The description focuses on a method and materials for dental bonding, which are physical components and procedures, not software. There is no mention of any software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "condition enamel and dentin to Obtain adhesive bonding of polymeric materials." This is a direct treatment or preparation of a patient's tissues (enamel and dentin) within the mouth.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue biopsies) to provide information about a person's health. They are used outside the body (in vitro means "in glass").
- Lack of Diagnostic Purpose: The device's purpose is not to diagnose a condition, monitor a disease, or screen for a health issue. It's a tool used in a restorative dental procedure.
- Anatomical Site: The anatomical site is "enamel and dentin," which are parts of the tooth within the body.
Therefore, this device falls under the category of a dental device used for treatment or preparation, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
This device/method is a means of conditioning enamel and dentin to Obtain adhesive bonding of polymeric materials. It is used by dental professionals in restorative procedures.
Product codes
KLE
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
enamel and dentin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professionals
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
§ 872.3200 Resin tooth bonding agent.
(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(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 features the department's name in a circular arrangement around a stylized symbol. The symbol is a graphic representation of an eagle or bird-like figure, with three horizontal lines forming the body and wings. The logo is black and white.
Public Health Service
Nov 2 9 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Bernard Sessman Miradent Distributing Company, L.L.C. 764 Speedwell Avenue, Suite 4 Morris Plains, NJ 07950-2231
к993013 Re: Trade Name: Sure Bond Requlatory Class: II Product Code: KLE November 15, 1999 Dated: November 23, 1999 Received:
Dear Mr. Sessman:
We have reviewed your Section 510(k) notification of intent to we have reviewed your beceier. Inve and we have determined the market the device foreices above (for the indications for device is substancially equilter marketed in interstate use stated in the encrosure) to devices mactment date of the Commerce prior co naments, or to devices that have been Medical Devree imendically, with the provisions of the Federal Feclassified in accordic Act (Act). You may, therefore, rood, Drug, and Cosmecre nee (ine general controls provisions evice, Babject and controls provisions of the Act of the Act. of the Act. The gon for annual registration, listing of ficiae requiremufacturing practice, labeling, and acvices, good manast misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may (Special Concrete) additional controls. Existing major be subject to such addrexo.device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A rederal Regulations, freic ar, ranton assumes compliance with substancially equivatent actical Devices: General the Good Manufacturing Fraction and that, through periodic (GMP) regulacion (21 Cris and Drug Administration (FDA) will GMP Inspections, the Food that to comply with the GMP vertify such assumpcions. In regulatory action. In addition, FDA regulation may rebarents concerning your device in may publish farcher announce: this response to your che reacration submission does not affect any
1
Page 2 - Mr. Sessman
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 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 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Patrícia Ciconetto
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
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| 510(k) Number (if known): | K99 3013 |
|---|---|
| Device Name: | SURE BOND |
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Indications For Use:
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This device/method is a means of conditioning enamel and dentin to Obtain adhesive bonding of polymeric materials. It is used by dental professionals in restorative procedures.
- ذلا
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Susan Runna | ||
|---|---|---|
| (Division Sign-Off) | ||
| Division of Dental, Infection Control, and General Hospital Devices | ||
| 510(k) Number | R093013 |
| Prescription Use ✓
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use ________ |
|---|---|---|
| -------------------------------------------------------------------------------------------- | ---- | ------------------------------- |
(Optional Format 1-2-96)