(86 days)
Not Found
No
The 510(k) summary describes a chemical bonding agent kit and makes no mention of AI or ML technology.
No
The device is described as a tooth bonding agent used for surface treatment and repair of dental prosthetics, not for treating a disease or condition.
No
The device is a dental restorative material (silane kit) used for bonding and surface treatment of dental prosthetics and repairs, not for diagnosing medical conditions.
No
The device description clearly states it is a "kit product that consists of three components, a primer, an etching agent and a silane coupling agent," 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 describes applications for repairing dental restorations (crowns) and treating the surface of prosthetic appliances. These are procedures performed directly on or in relation to a patient's dental structure or prosthetics, not on samples taken from the body for diagnostic purposes.
- Device Description: The device is described as a "resin tooth bonding agent" intended to be painted on the surface of dental materials. This aligns with a dental restorative or bonding product, not an IVD which would typically be used to analyze biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
The device's classification under CFR 21 Section 872.3200 (resin tooth bonding agent) further confirms its classification as a dental device, not an IVD.
N/A
Intended Use / Indications for Use
CLEARFIL SILANE KIT is indicated for the following applications:
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- Intraoral repairs of fractured facing crowns made of porcelain, hybrid ceramics or composite resin using light curing composite.
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- Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics and cured composite resin.
Product codes (comma separated list FDA assigned to the subject device)
KLE
Device Description
CLEARFIL SILANE KIT is classified into the resin tooth bonding agent, CFR 21 Section 872.3200, because it is a device composed of materials such as dimethacrylate monomers intended to paint on the surface of a porcelain, hybrid ceramics and composite resin. This device is a kit product that consists of three components, a primer, an etching agent and a silane coupling agent.
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): 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.
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.
Not Found
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).
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
[CLEARFIL SILANE KIT, Kuraray Medical Inc.]
510(k) SUMMARY
| 1) Name | KURARAY MEDICAL INC. |
|---|---|
| 2) Address | 1621 Sakazu, Kurashiki, Okayama 710-8622, Japan |
| 3) 1. Contact person | Koji Nishida |
| Dental Material Department, Kuraray Medical Inc. | |
| 2. Contact person in U.S.A. | Masaya Sasaki |
| Kuraray America Inc. | |
| 101 East 52nd Street, 26th Floor | |
| New York, NY 10022 | |
| Telephone: (212)-986-2230 (Ext.115) | |
| 1-(800)-879-1676 | |
| Facsimile: (212)-867-3543 | |
| 4) Date | December 27, 2002 |
| 2. Name of Device | |
| 1) Proprietary Name | CLEARFIL SILANE KIT |
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Common/Usual Name
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Classification Name
- Submitter
Resin tooth bonding agent (21CFR 872.3200) Surface treatment system for porcelain, hybrid ceramics and cured composite resin
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- Predicate device:
The predicate devices are as follows.
- Predicate device:
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- CLEARFIL SE BOND manufactured by Kuraray Medical Inc. (K012442)
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- CLEARFIL PORCELAIN BOND ACTIVATOR manufactured by Kuraray Medical Inc. (K012730)
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- CLEARFIL PHOTO BOND manufactured by Kuraray Medical Inc. (K012432)
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4 Description for the premarket notification
CLEARFIL SILANE KIT is classified into the resin tooth bonding agent, CFR 21 Section 872.3200, because it is a device composed of materials such as dimethacrylate monomers intended to paint on the surface of a porcelain, hybrid ceramics and composite resin.
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5 Statement of the intended use
The intended uses of this device are as follows. They are included in those of CLEARFIL SE BOND (K012442). -
- Intraoral repairs of fractured facing crowns made of porcelain, hybrid ceramics or composite resin using light curing composite.
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- Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics and cured composite resin.
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- Statement of the technological characteristics and safety
This device is a kit product that consists of three components, a primer, an etching agent and a silane coupling agent. These three components are same components in the legally marketed predicate devices: CLEARFIL SE BOND, CLEARFIL PORCELAIN BOND ACTIVATOR and CLEARRIL PHOTO BOND. Additionally, the combination use of these components is described in the instructions for use of CLEARFIL SE BOND.
Therefore this device is substantially equivalent of the legally marketed predicate devices in the technological characteristics, chemical ingredients and safety.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping profiles of human faces, creating a sense of community and connection.
MAR 2 6 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Kuraray Medical Incorporated C/O Ms. Masaya Sasaki Kuraray America, Incorporated 101 East 52nd Street, 26th Floor New York, New York 10022
Re: K024356
Trade/Device Name: Clearfil Silane Kit Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: December 27, 2002 Received: December 30, 2002
Dear Ms. Sasaki:
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.
2
Page 2 - Ms. Sasaki
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 (301) 594-4613. 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.
Susan Runno
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
[CLEARFIL SILANE KIT, Kuraray Medical Inc.]
€ 10(k) Number (if known): K024 356
l Device Name: CLEARFIL SILANE KIT
Indications for Use
CLEARFIL SILANE KIT is indicated for the following applications:
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- Intraoral repairs of fractured facing crowns made of porcelain, hybrid ceramics or composite resin using light curing composite.
-
- Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics and cured composite resin.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X OR Over-The-Counter Use
(Optional Format 1-2-96)
Kein Muly Soe MSK
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(k) Number: K024956