(36 days)
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Not Found
No
The provided text describes a dental bonding agent and its intended uses, with no mention of AI or ML technology.
No
The device is indicated for various dental applications such as restorations, cavity sealing, and repairs, which are not considered therapeutic but rather restorative or maintenance procedures.
No
The document describes a dental bonding agent (CLEARFIL TRI-S BOND) used for various restorative and repair applications, none of which involve diagnosing a medical condition.
No
The provided text describes a dental bonding agent (CLEARFIL TRI-S BOND), which is a physical material, not a software application. The description focuses on its intended uses in dental procedures.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The listed intended uses are all related to dental procedures performed directly on a patient's teeth or existing dental work (restorations, cavity sealing, root surface treatment, repairs, surface treatment of prosthetic appliances, core build-ups). These are clinical applications, not laboratory tests performed on samples taken from the body.
- 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.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, based on the provided text, CLEARFIL TRI-S BOND is a dental material used in clinical procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
CLEARFIL TRI-S BOND is indicated for the following applications:
1)Direct restorations using light-cured composite resin
2)Cavity sealing as a pretreatment for indirect restorations
3)Treatment of exposed root surfaces
4)Intraoral repairs of fractured crowns/bridges made of porcelain or composite resin 5)Surface treatment of prosthetic appliances made of porcelain or composite resin
6)Core build-ups using light- or dual- cured composite resin
Product codes
KLE
Device Description
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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)
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Reference Device(s)
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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 is circular and contains the department's name around the perimeter. In the center of the logo is an abstract symbol that represents the human form. The symbol is composed of three stylized figures that are interconnected.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 26 2004
Kuraray Medical, Incorporated C/O Mr. Satoshi Yamaguchi Kurarav America, Incorporated 101 East 52nd Street, 26th floor New York, New York 10022
Re: K042913
Trade/Device Name: CLEARFIL TRI-S BOND Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: KLE Dated: October 18, 2004 Received: October 27, 2004
Dear Mr. Yamaguchi:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition. FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Yamaguchi
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Chiu Lin, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K042913 Device Name: CLEARFIL TRI-S BOND Indications For Use:
CLEARFIL TRI-S BOND is indicated for the following applications:
1)Direct restorations using light-cured composite resin
2)Cavity sealing as a pretreatment for indirect restorations
3)Treatment of exposed root surfaces
4)Intraoral repairs of fractured crowns/bridges made of porcelain or composite resin 5)Surface treatment of prosthetic appliances made of porcelain or composite resin
6)Core build-ups using light- or dual- cured composite resin
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital, | |
| Infection Control, Dental Devices |
| 510(k) Number: | K042913 |
|---|---|
| ---------------- | --------- |
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