CLEARFIL SE BOND

K990040 · Kuraray Co. · KLE · Feb 4, 1999 · Dental

Device Facts

• Record ID: K990040
• Device Name: CLEARFIL SE BOND
• Applicant: Kuraray Co.
• Product Code: KLE · Dental
• Decision Date: Feb 4, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

1) Direct filling restorations using light-curing composite or compomer 2) Cavity sealing as a pretreatment for indirect restorations 3) Treatment of hypersensitive and/or exposed root surfaces 4) Intraoral repairs of fractured facing crowns made of porcelain, hybrid ceramics or composite resin using light-curing composite 5) Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics and cured composite resin

Device Story

CLEARFIL SE BOND is a resin-based dental adhesive system; composed of dimethacrylate monomers; used by dentists in clinical settings. Device functions as a bonding agent to improve retention of restorative materials to tooth structure. Applied to prepared tooth cavities or prosthetic surfaces; facilitates adhesion of light-curing composites or compomers. Benefits include improved restoration retention, reduced hypersensitivity, and enabling repair of fractured dental crowns. No complex electronic processing or software involved.

Clinical Evidence

Bench testing only. Bond strength to human enamel, dentin, and porcelain was evaluated and compared to predicate device CLEARFIL LINER BOND 2V. Results indicate performance is substantially equivalent to the predicate.

Technological Characteristics

Resin-based dental adhesive system consisting of Primer, Bonding Agent, and Etching Agent. Primary chemical components include dimethacrylate monomers. System is a simplified version of the predicate CLEARFIL LINER BOND 2V. No electronic components, software, or connectivity features.

Indications for Use

Indicated for dental patients requiring direct light-cured composite/compomer restorations, cavity sealing for indirect restorations, treatment of hypersensitive/exposed root surfaces, intraoral repair of fractured crowns (porcelain, hybrid ceramic, or composite), and surface treatment of prosthetic appliances.

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 LINER BOND 2V (K974486)

Reference Devices

• CLEARFIL LINER BOND 2 (K943170)
• CLEARFIL PHOTO BOND (K943165)
• PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL BONDING AGENT WITH ACTIVATOR (K964525)
• GLUMA ONE BOND (K974390)
• ONE STEP UNIVERSAL DENTAL ADHESIVE SYSTEM (K910860)
• ALL-BOND 2 (K934690)
• OPTIBOND (KERR MFG.CO) (K934690)
• PANAVIA F (K983361)
• ESTENIA (K982164)

Submission Summary (Full Text)

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FEB 400000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000 ধ

K990040

(K943170)

(K943165)

# KURAF

12-39, 1-Chome, Umeda, Kita-ku, Osaka 530-86 : [phone] Phone Facsimile: [phone]

## 510(k) SUMMARY

#### 1. Submitter

| 1) Name | KURARAY CO., LTD. |
|-------------------|-----------------------------------------------------------------------------|
| 2) Address | 1-12-39, Umeda, Kita-ku, Osaka 530-8611, Japan |
| 3) Telephone | 81(Japan)-6-6348-2603 |
| 4) Facsimile | 81(Japan)-6-6348-2552 |
| 5) Contact person | Yoshinori Nagase<br>Dental Material Department<br>Medical Products Division |
| 6) Date | January 6, 1999 |

#### 2. Representing (Subsidiary of KURARAY CO., LTD.)

| 1) Name | KURARAY AMERICA INC. |
|-------------------|-------------------------------------------------------------------|
| 2) Address | 30th Fl. Metlife Building, 200 Park Avenue, New York,<br>NY 10166 |
| 3) Telephone | (212)-986-2230 |
| 4) Facsimile | (212)-867-3543 |
| 5) Contact person | Koji Fujita<br>President |

#### 3. Name of Device

| 1) Proprietary Name | CLEARFIL SE BOND |
|------------------------|--------------------------------------------|
| 2) Classification Name | Resin tooth bonding agent (21CFR 872.3200) |
| 3) Common/Usual Name | Resin-based dental adhesive system |

#### র্ব-Predicate devices:

| | 1. CLEARFIL LINER BOND 2V by KURARAY CO.,LTD. | (K974486) |
|--|-----------------------------------------------|-----------|
|--|-----------------------------------------------|-----------|

- CLEARFIL LINER BOND 2 by KURARAY CO.,LTD. 2.
- 3. CLEARFIL PHOTO BOND by KURARAY CO.,LTD.
- PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL (K964525) 4. BONDING AGENT WITH ACTIVATOR by DENTSPLY
-
- GLUMA ONE BOND by HERAEUS KULZER, INC. (K974390) 5. (K#unknown) ONE STEP UNIVERSAL DENTAL ADHESIVE SYSTEM by BISCO, 6.
- INC. (K910860) 7. ALL-BOND 2 by BISCO, INC.
- (K934690) OPTIBOND by KERR MFG.CO 8.
- 5. Description for the premarket notification

CLEARFIL SE BOND 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 painted on the interior of a prepared cavity of a tooth to improve retentive materials.

This product is similar and substantially equivalent in design, composition and function to the

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similar products which are identified in the paragraph 4 of this summary; all of which are safe, effective and beneficial.

#### 6. Statement of the intended use

Statement of the firended aso products.

| | 1) Direct filling restorations using light-curing composite or compomer | |
|----|-----------------------------------------------------------------------------------------|-------------|
| a) | CLEARFIL LINER BOND 2V by KURARAY CO., LTD. | (K974486) |
| b) | CLEARFIL LINER BOND 2 by KURARAY CO., LTD. | (K943170) |
| c) | PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL<br>BONDING AGENT WITH ACTIVATOR by DENTSPLY | (K964525) |
| d) | GLUMA ONE BOND by HERAEUS KULZER, INC. | (K974390) |
| | | |
| | 2) Cavity sealing as a pretreatment for indirect restorations | |
| a) | CLEARFIL LINER BOND 2V by KURARAY CO., LTD. | (K974486) |
| b) | ONE STEP UNIVERSAL DENTAL ADHESIVE SYSTEM by<br>BISCO, INC. | (K#unknown) |
| c) | ALL-BOND 2 by BISCO, INC. | (K910860) |
| d) | OPTIBOND by KERR MFG.CO | (K934690) |
| | | |
| | 3) Treatment of hypersensitive and/or exposed root surfaces | |
| a) | CLEARFIL LINER BOND 2V by KURARAY CO., LTD. | (K974486) |
| b) | CLEARFIL LINER BOND 2 by KURARAY CO., LTD. | (K943170) |

- PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL (K964525) c) BONDING AGENT WITH ACTIVATOR by DENTSPLY
- ONE STEP UNIVERSAL DENTAL ADHESIVE SYSTEM by (K#unknown) d) BISCO, INC.
- Intraoral repairs of fractured facing crowns made of porcelain, hybrid ceramics or 4) composite resin using light-curing composite

| a) CLEARFIL LINER BOND 2V by KURARAY CO., LTD. | (K974486) |
|--------------------------------------------------------------------------------------------|-----------|
| b) PRIME & BOND 2.1 MULTIPURPOSE DENTIN/ENAMEL<br>BONDING AGENT WITH ACTIVATOR by DENTSPLY | (K964525) |

- 5) Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics and cured composite resin

| a) CLEARFIL LINER BOND 2V by KURARAY CO., LTD. | (K974486) |
|------------------------------------------------|-----------|
| b) CLEARFIL PHOTO BOND by KURARAY CO., LTD. | (K943165) |

- 7. Statement of the technological characteristics and safety
Buttems of the wonners great as a simplified system of CLEARFIL LINER BOND 2V permitted to be marketed (K974486). CLEARFIL SE BOND is substantially equivalent to those of products sold in the U.S. market in design, components and functions.

- 7-1 Components
CLEARFIL SE BOND consists of Primer, Bonding Agent, Etching Agent and accessories. These components are similar to those of the products in the paragraph 4 of this summary.

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#### 7-2 Performance

Periormance
There is no ISO standard applicable to CLEARFIL SE BOND. The bond strengths to human There Is no too standard appricable to cl and porcelain were evaluated in comparison with enamel, numan dentife, precious mocal are performances are substantially equivalent to those of CLEARFIL LINER BOND 2V.

### 7-3 Chemical ingredients and safety

The chemical ingredients and bacty The chemical ingredictive have been use an in ial y equivalent to the predicated devices.

- CLEARFIL LINER BOND 2V by KURARAY CO., LTD. (K974486) a) (K983361) PANAVIA F by KURARAY CO., LTD. b)
- (K982164) ESTENIA by KURARAY CO., LTD. c)

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Image /page/3/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB ! 4 1999

Kuraray Co., Ltd. C/O Mr. Koji Fujita President Kuraray America, Incorporated 30th FI Metlife Building 200 Park Avenue New York, New York 10166-3098

Re : K990040 CLEARFIL SE BOND Trade Name: Regulatory Class: II Product Code: KLE January 6, 1999 Dated: January 6, 1999 Received:

Dear Mr. Fujita:

We have reviewed your Section 510(k) notification of intent to we have reviewed your becoed above and we have determined the market the device refly equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Commerce prior co nay ents, or to devices that have been Medical Device imendance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, rood, Drug, and commons to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of Include requiremufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may (opecial ochorsuch additional controls. Existing major be subject to back accoundevice can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A rederal Regulation ent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic (URL) regections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP vegulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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Page 2 - Mr. Fujita

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA described in your tial equivalence of your device to a legally Finding of substancial equires in a classification for your marketed predicate device burned to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be Information on Jour Chilison of Small Manufacturers Assistance at its toll-free number (800) 638-20#1 or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

Timo Directbr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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Image /page/5/Picture/0 description: The image shows the text "K990040" in a bold, sans-serif font. Below this, the text "[CLEARFIL SE BOND, Kuraray]" is printed in a smaller, serif font. The text appears to be part of a label or product identifier.

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K990040

CLERFIL SE BOND Device Name: _

Indications For Use

CLEARFIL SE BOND is indicated for the following applications:

Ard III OL DOND is managing light-curing composite or compomer 1)

- Cavity sealing as a pretreatment for indirect restorations 2)
- Oavity seaming as a prositive and/or exposed root surfaces 3)
- Treatment of dypersensitive andor exposed root successor
Intraoral repairs of fractured facing crowns made of porcelain, hybrid ceramics and cured 4) composite resin
- composite resin
Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics and cured 5) composite resin

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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