(35 days)
No
The device description and intended use clearly define it as a resin tooth bonding agent with a chemical composition, and there is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.
No
The device is a bonding agent used to improve retention of restorative materials in teeth for procedures like direct restorations or core build-ups, not to treat or cure a disease or condition.
No
The device description and intended use indicate that this product is a resin tooth bonding agent used for restorative purposes, such as improving retention of restorative materials and cavity sealing. There is no mention of the device being used to diagnose a condition.
No
The device is a resin tooth bonding agent, which is a physical material applied to teeth, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to dental procedures performed directly on the patient's tooth (direct restorations, cavity sealing, treating exposed root surfaces, core build-ups). IVDs are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The device is described as a "resin tooth bonding agent" intended to be painted on the interior of a prepared cavity of a tooth. This is a material applied to the body, not used to test a sample from the body.
- CFR Classification: The device is classified under CFR 21 Section 872.3200, which is for "Resin tooth bonding agent." This classification falls under the category of dental devices, not in vitro diagnostic devices.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, based on the provided text, Clearfil tri-S bond Single dose is a dental device used for bonding restorative materials to teeth, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Clearfil tri-S bond Single dose is indicated for the following applications:
-
- Direct restorations using light cured composite resin
-
- Cavity sealing as a pretreatment for indirect restorations
-
- Treatment of exposed root surfaces
-
- Core build-ups using light- or dual-cured composite resin
Product codes
KLE
Device Description
This device 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 be painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth, dentin
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
The bond strengths between bovine tooth and a composite resin, between bovine dentin and core build up composite resin and marginal sealing were evaluated in comparison with Clearfil tri-S bond.
Key Metrics
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
[Clearfil tri-S bond Single dose, Kuraray Medical Inc.] AUG 9 - 2005
510(k) SUMMARY
- Submitter
| 1) Name | KURARAY MEDICAL INC. |
|---|---|
| 2) Address | 1621 Sakazu, Kurashiki, Okayama 710-8622, Japan |
| 3) 1. Contact person | Masaya Sasaki |
| Dental Material Division, Kuraray Medical Inc. | |
| 2. Contact person in U.S.A. | Satoshi Yamaguchi |
| 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 | October XX, 2004 |
2. Name of Device
| 1) Proprietary Name | Clearfil tri-S bond Single dose |
|---|---|
| 2) Classification Name | Resin tooth bonding agent (21CFR 872.3200) |
| 3) Common/Usual Name | Resin-based dental adhesive system |
- Predicate device
The predicate device is as follow; a) Resin Tooth Bonding Agent 1. Clearfil tri-S bond
by Kuraray Medical Inc. (K042913)
4. Description for the premarket notification
This device 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 be painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials.
1
5. Statement of the intended use
The intended use of this device is as follows. It is the same as that of Clearfil triS bond (K042913) manufactured by Kuraray Medical Inc.
| Indications for Use | Predicate device |
|---|---|
| 1) Direct restorations using light-cured composite resin |
- Cavity sealing as a pretreatment for indirect
restorations - Treatment of exposed root surfaces
- Core build-ups using light- or dual-cured composite resin | Clearfil tri-S bond (K042913) |
- Statement of the safety and technological characteristics
6-1. Safty
The ingredients and composition of this device are the same as that of Clearfil tri-S bond (K042913) and it only differs in that it is filled in single dose tips (disposable tips). Therefore this device is the same as the legally marketed predicate devices, Clearfil tri S bond, in respect of safety.
6-2. Technological characteristics
The bond strengths between bovine tooth and a composite resin, between bovine dentin and core build up composite resin and marginal sealing were evaluated in comparison with Clearfil tri-S bond . As to the result, this device is substantially equivalent to the legally marketed predicate devices, Clearfil tri-S bond, in effectiveness.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal is circular and features the department's name around the perimeter. In the center is an abstract emblem resembling an eagle or bird-like figure, composed of curved lines. The overall design is simple and monochromatic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 9 - 2005
Kuraray Medical, Incorporated C/O Mr. Satoshi Yamaguchi Kuraray America, Incorporated 101 East 52nd Street, 26th Floor New York, New York 10022
Re: K051796
Trade/Device Name: Clearfil™ tri-S Bond Single Dose Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: July 01, 2005 Received: July 12, 2005
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.
3
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 (OS) 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" (21 CFR 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/industry/support/index.html.
Sincerely vours.
Susan Runne
Chiu S. Lin, PhD Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known):
Device Name: Clearfil tri-S bond Single dose
Indications for Use
Clearfil tri-S bond Single dose is indicated for the following applications:
-
- Direct restorations using light cured composite resin
-
- Cavity sealing as a pretreatment for indirect restorations
-
- Treatment of exposed root surfaces
-
- Core build-ups using light- or dual-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
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Susan Gunn
(Division Sign-Off)
Division of Anesthesiology, General Hosp
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number: