CLEARFIL TRI-S BOND

K042913 · Kuraray Medical, Inc. · KLE · Nov 26, 2004 · Dental

Device Facts

• Record ID: K042913
• Device Name: CLEARFIL TRI-S BOND
• Applicant: Kuraray Medical, Inc.
• Product Code: KLE · Dental
• Decision Date: Nov 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended 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

Device Story

CLEARFIL TRI-S BOND is a dental adhesive system used by dentists in clinical settings. It functions as a bonding agent to facilitate adhesion between tooth structure and restorative materials (composite resin) or to seal surfaces. Applied topically by the clinician during restorative procedures; it improves retention and marginal integrity of restorations. Benefits include reduced sensitivity via root surface treatment and versatility in repairing existing dental prosthetics.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Light-cured dental adhesive system; classified as tooth shade resin material (21 CFR 872.3690).

Indications for Use

Indicated for dental patients requiring direct light-cured composite restorations, cavity sealing for indirect restorations, treatment of exposed root surfaces, intraoral repair of fractured porcelain or composite crowns/bridges, surface treatment of prosthetic appliances, and core build-ups using light- or dual-cured composite resin.

Regulatory Classification

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.

Submission Summary (Full Text)

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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 [phone]. 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 [phone] or [phone] 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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