(77 days)
Not Found
No
The summary describes a dental bonding agent, a chemical product, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is a bonding primer used in dental procedures to enhance adhesion of resin filling material and for sealing exposed dentin/root surfaces, which is a restorative function, not a therapeutic one that treats or cures a disease or condition.
No
The device is described as a bonding primer/agent used to enhance adhesion of resin filling material to the tooth and for sealing surfaces. It does not perform any diagnostic function.
No
The device description clearly states it is a "resin tooth bonding agent," 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: The intended use is for bonding resin filling material to teeth and sealing exposed dentin and root surfaces in dental procedures. This is a direct application to the patient's body for a therapeutic or restorative purpose.
- Device Description: The description reinforces its use as a "resin tooth bonding agent" applied to the tooth.
- Lack of IVD Characteristics: There is no mention of analyzing samples in vitro (outside the body) to provide information about a patient's health status, disease, or condition. IVDs typically involve testing blood, urine, tissue, or other biological samples.
Therefore, this device falls under the category of a dental restorative material used directly on the patient, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
For use in dental procedures as a bonding primer with light cured resin filling material to enhance the adhesion of resin filling material to the tooth and for sealing of exposed cervical dentin and root surfaces.
Product codes
KLE
Device Description
The product is a resin tooth bonding agent for use with Tokuyama's Tokuso Estelite or other types of light cured composite resins to enhance the bonding of these materials to the tooth and for sealing of exposed cervical dentin and root surfaces.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
tooth, cervical dentin, root surfaces
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental practitioners
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
§ 872.3200 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
2 2000 FEB
510(k) Summary
Submitted by: Daniel J. Manelli Farkas & Manelli, P.L.L.C. 2000 M Street, NW (Suite 700) Washington, DC 20036 Telephone: 202-261-1000
On behalf of Tokuyama America, Inc. 510(k) Submission: One-Up Bond F November 17, 1999
The product is a resin tooth bonding agent for use with Tokuyama's Tokuso Estelite or other types of light cured composite resins to enhance the bonding of these materials to the tooth and for sealing of exposed cervical dentin and root surfaces.
The product is for use only by dental practitioners; it is not intended for OTC use. It contains materials that pose no health hazard when used according to directions and has received the approval of the Japanese Government. The product is substantially equivalent to various marketed bonding agents, including Tokuyama's Tokuso Mac Bond II (K980058).
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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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three horizontal lines that curve and flow together, resembling a symbol or abstract representation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 2000
Mr. Daniel J. Manelli, Esquire Farkas & Manelli PLLC Attorneys 2000 M Street N.W., 7th Floor Washington, D.C. 20036-3307
Re : K993917
Tokuyama America - One-Up-Bond F Trade Name: Requlatory Class: II Product Code: KLE Dated: January 20, 2000 Received: January 21, 2000
Dear Mr. Manelli:
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 registration, 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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Paqe 2 - Mr. Manelli
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.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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Page _ 1__ of _ 1
510{k) Number (if known): K993917
Device Name:
Indications For Use:
For use in dental procedures as a bonding primer with light cured resin filling material to enhance the adhesion of resin filling material to the tooth and for sealing of exposed cervical dentin and root surfaces.
(Please Do Not Write Below This Line - Continue 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
Susan Rupper
(Division Sian-Off Division of Dental, Infection Contro and General Hosp 510(k) Number
(Optional Format 1/2/96)