MODIFICATION TO CLEARFIL LINER BOND 2V

K012440 · Kuraray Medical, Inc. · KLE · Sep 5, 2001 · Dental

Device Facts

• Record ID: K012440
• Device Name: MODIFICATION TO CLEARFIL LINER BOND 2V
• Applicant: Kuraray Medical, Inc.
• Product Code: KLE · Dental
• Decision Date: Sep 5, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

1) Direct filling restorations using light-cure or chemical-cure composite resin 2) Bonded amalgam restorations 3) Treatment of hypersensitive and/or exposed root surfaces 4) Cavity sealing as a pretreatment for indirect restorations 5) Intraoral repairs of facing crowns using light-cure composite resin 6) Cementing laminate veneers, inlays and onlays made of porcelain (or composite resin) using composite resin cement

Device Story

CLEARFIL LINER BOND 2V is a resin-based dental adhesive system composed of dimethacrylate monomers. It is applied by dental professionals to prepared tooth cavities to improve the retention of restorative materials. The device functions as a bonding agent for direct composite or amalgam restorations, a sealant for hypersensitive root surfaces, and a pretreatment for indirect restorations. It is also used for intraoral repairs of facing crowns and the cementation of porcelain or composite resin veneers, inlays, and onlays. The device is used in a clinical dental setting.

Clinical Evidence

No clinical data provided; substantial equivalence is based on the device being identical to the previously cleared predicate.

Technological Characteristics

Resin-based dental adhesive system composed of dimethacrylate monomers. The device is chemically and technologically identical to the predicate device (K974486).

Indications for Use

Indicated for dental patients requiring direct composite or amalgam restorations, treatment of hypersensitive or exposed root surfaces, cavity sealing for indirect restorations, intraoral repair of facing crowns, and cementation of porcelain or composite resin veneers, inlays, and onlays.

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)

Submission Summary (Full Text)

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SEP - 5 2001

[CLEARFIL LINER BOND 2V, Kuraray Medical Inc.]

# KURARAY MEDICAL INC.

KO12440

Image /page/0/Picture/4 description: The image is a logo for Kuraray. The logo is a black square with a white stylized "K" inside. The "K" is made up of geometric shapes, and the word "KURARAY" is printed in white below the "K". The logo is simple and modern.

Dental Material Department 12-39. 1-Chome, Umeda, Kita-ku, Osaka 530-8611, JAPAN : [phone] Facsimile: [phone]

# 510(k) SUMMARY

#### 1. Submitter

| 1) | KURARAY MEDICAL INC. |
|-----------------------------|-------------------------------------------------------|
| 2) Address | 1621 Sakazu, Kurashiki, Okayama 710-8622, Japan |
| 3) Contact person | Koji Nishida |
| | DENTAL MATERIAL DEPARTMENT |
| 4) Date | July 23, 2001 |
| 5) Contact person in U.S.A. | Masaya Sasaki |
| | 30th Fl. Metlife Building, 200 Park Avenue, New York, |
| | NY 10166 |
| | Telephone : [phone] |
| | 1(800)-879-1676 |
| | Facsimile : (212)-867-3543 |

#### 2. Name of Device

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

#### 3. Predicate device:

Kuraray Co., Ltd. will transfer the medical device business and the relevant functions including manufacturing facilities to its subsidiary company named Kuraray Medical Inc. on The aim of 510(k) submission is to alter the name and address of October 1st 2001. manufacturer, and not to intend other changes.

The predicate device is as follow.

(K974486) CLEARFIL LINER BOND 2V by Kuraray Co., Ltd. 1.

#### 4. Description for the premarket notification

CLEARFIL LINER BOND 2V 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 retention of restorative materials. PROTECT LINER F is classified into tooth shade resin material, CFR 21 Section 872.3690, because it is a device composed of material such as bisphenol A glycidylmethacrylate (Bis-GMA) intended to restore carious or structural defects in teeth. CLEARFIL PORCELAIN BOND ACTIVATOR was permitted to market under its 510(k) notification submission.

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### 5. Statement of the intended use

The intended uses of this device are as follows. They are completely the same as CLEARFIL LINER BOND 2V manufactured by Kuraray Co., Ltd. (K974486).

- 1) Direct filling restorations using light-cure or chemical-cure composite resin
- 2) Bonded amalgam restorations
- 3) Treatment of hypersensitive and/or exposed root surfaces
- 4) Cavity sealing as a pretreatment for indirect restorations
- 5) Intraoral repairs of facing crowns using light-cure composite resin
- 6) Cementing laminate veneers, inlays and onlays made of porcelain (or composite resin) using composite resin cement
- 6. Statement of the technological characteristics and safety

This device is essentially the same as CLEARFIL LINER BOND 2V manufactured by Kuraray Co., Ltd. (K974486). Therefore the technological characteristics, chemical ingredients and safety of this device are completely the same as CLEARFIL LINER BOND 2V.

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Image /page/2/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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines that converge at the bottom.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 5 2001

Kuraray Medical Incorporated C/O Ms. Masaya Sasaki Kuraray America, Incorporated 30th Floor Metlife Building 200 Park Avenue New York, New York 10166

K012440 Re : Modification To Clearfil Liner Trade/Device Name: Bond 2V 872.3200 Requlation Number: II Requlatory Class: Product Code: KLE Dated: Jul 23, 2001 Received: July 31, 2001

Dear Ms. Sasaki:

We have reviewed your Section 510(k) notification of intent to we have reviewed referenced above and we have determined the market the abrantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate use stated in the choiobane commerce prior to May 28, 1976, devices mariesoa of the Medical Device Amendments, or to the enacement acobeen reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 provision, 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಗ್ಗೆ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory

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Page 2 - Ms. Sasaki

In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does ent affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic enroagn Siz or or or on control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 markees probles, permits your device 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Timothy A. Ulatowski

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: CLEARFIL LINER BOND 2V

## Indications for Use

CLEAFIL LINER BOND 2V is indicated for the following applications:

- Direct filling restorations using light-cure or chemical-cure composite resin 1)
- 2) Bonded amalgam restorations
- 3) Treatment of hypersensitive and/or exposed root surfaces
- Cavity sealing as a pretreatment for indirect restorations 4)
- 5) Intraoral repairs of facing crowns using light-cure composite resin
- 6) Cementing laminate veneers, inlays and onlays made of porcelain (or composite resin) using composite resin cement

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (Part 21 CFR 801.109)

OR

Over-The-Counter Use_

(Optional Format 1-2-96)

Susan Runner

(Division Sign-Off)

Division of Dental, Infection Control, and General Hospital Devices ******************************************************************************************************************************************************************************