CLEARFIL SILANE KIT

K024356 · Kuraray Medical, Inc. · KLE · Mar 26, 2003 · Dental

Device Facts

• Record ID: K024356
• Device Name: CLEARFIL SILANE KIT
• Applicant: Kuraray Medical, Inc.
• Product Code: KLE · Dental
• Decision Date: Mar 26, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

1) Intraoral repairs of fractured facing crowns made of porcelain, hybrid ceramics or composite resin using light curing composite. 2) Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics and cured composite resin.

Device Story

CLEARFIL SILANE KIT is a dental surface treatment system; consists of three components: primer, etching agent, and silane coupling agent. Used by dentists for intraoral repair of fractured dental crowns (porcelain, hybrid ceramics, composite resin) and surface treatment of prosthetic appliances. Components are applied to the surface to facilitate bonding with light-curing composite. Benefits include improved adhesion for dental restorations.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Kit containing primer, etching agent, and silane coupling agent. Composed of dimethacrylate monomers. Chemical composition and technological characteristics are identical to predicate devices.

Indications for Use

Indicated for intraoral repair of fractured porcelain, hybrid ceramic, or composite resin crowns using light-curing composite, and for surface treatment of prosthetic appliances made of these same materials.

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.

Predicate Devices

• CLEARFIL SE BOND (K012442)
• CLEARFIL PORCELAIN BOND ACTIVATOR (K012730)
• CLEARFIL PHOTO BOND (K012432)

Submission Summary (Full Text)

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[CLEARFIL SILANE KIT, Kuraray Medical Inc.]

K024356

## 510(k) SUMMARY

| 1) Name | KURARAY MEDICAL INC. |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2) Address | 1621 Sakazu, Kurashiki, Okayama 710-8622, Japan |
| 3) 1. Contact person | Koji Nishida<br>Dental Material Department, Kuraray Medical Inc. |
| 2. Contact person in U.S.A. | Masaya Sasaki<br>Kuraray America Inc.<br>101 East 52nd Street, 26th Floor<br>New York, NY 10022<br>Telephone: [phone] (Ext.115)<br>1-(800)-879-1676<br>Facsimile: (212)-867-3543 |
| 4) Date | December 27, 2002 |
| 2. Name of Device | |
| 1) Proprietary Name | CLEARFIL SILANE KIT |

3) Common/Usual Name

2) Classification Name

1. Submitter

Resin tooth bonding agent (21CFR 872.3200) Surface treatment system for porcelain, hybrid ceramics and cured composite resin

- 3. Predicate device:
The predicate devices are as follows.

- 1) CLEARFIL SE BOND manufactured by Kuraray Medical Inc. (K012442)
- 2) CLEARFIL PORCELAIN BOND ACTIVATOR manufactured by Kuraray Medical Inc. (K012730)
- 3) CLEARFIL PHOTO BOND manufactured by Kuraray Medical Inc. (K012432)
- 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.

- 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).

- 1) Intraoral repairs of fractured facing crowns made of porcelain, hybrid ceramics or composite resin using light curing composite.
- 2) Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics and cured composite resin.
- 6. 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.

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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.

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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 [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.

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

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[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:

- 1) Intraoral repairs of fractured facing crowns made of porcelain, hybrid ceramics or composite resin using light curing composite.
- 2) 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