CLEARFIL REPAIR

K012729 · Kuraray Medical, Inc. · KLE · Sep 13, 2001 · Dental

Device Facts

• Record ID: K012729
• Device Name: CLEARFIL REPAIR
• Applicant: Kuraray Medical, Inc.
• Product Code: KLE · Dental
• Decision Date: Sep 13, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1) Intraoral repairs of fractured porcelain or composite facing crowns/bridges 2) Intraoral repairs of fractured all ceramics restorations 3) Intraoral repairs of fractured porcelain and composite inlays/onlays

Device Story

CLEARFIL REPAIR is a resin-based dental adhesive system composed of dimethacrylate monomers. It is applied by dental professionals to the interior of prepared tooth cavities or fractured surfaces to improve retention of restorative materials. The device is used for intraoral repair of fractured porcelain, composite, or all-ceramic restorations. It functions as a bonding agent to facilitate the repair of dental prosthetics, potentially extending the service life of existing restorations and avoiding more invasive replacement procedures.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Resin-based dental adhesive system; composition includes dimethacrylate monomers; classified as a resin tooth bonding agent (21 CFR 872.3200).

Indications for Use

Indicated for intraoral repair of fractured porcelain or composite facing crowns/bridges, all-ceramic restorations, and porcelain/composite inlays/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 REPAIR by Kuraray Co., Ltd. (K001914)

Submission Summary (Full Text)

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## KURARAY MEDICAL INC.

Image /page/0/Picture/2 description: The image is a black and white logo for Kuraray. The logo features a stylized letter 'K' formed by thick lines, with a smaller, geometric shape nested within it. Below the symbol, the word 'KURARAY' is printed in block letters.

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

# KO12729

### 510(k) SUMMARY

| 1. Submitter | |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1) Name | KURARAY MEDICAL INC. |
| 2) Address | 1621 Sakazu, Kurashiki, Okayama 710-8622, Japan |
| 3) Contact person | Koji Nishida<br>DENTAL MATERIAL DEPARTMENT |
| 4) Date | August 9, 2001 |
| 5) Contact person in U.S.A. | Masaya Sasaki<br>30th Fl. Metlife Building, 200 Park Avenue, New York, NY 10166<br>Telephone : [phone]<br>1-(800)-879-1676<br>Facsimile : (212)-867-3543 |

#### 2. Name of Device

| 1) Proprietary Name | CLEARFIL REPAIR |
|------------------------|--------------------------------------------|
| 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 October 1st 2001. The aim of 510(k) submission is to alter the name and address of manufacturer, and not to intend other changes.

The predicate device is as follow.

- CLEARFIL REPAIR by Kuraray Co., Ltd. (K001914) 1.
- 4. Description for the premarket notification

CLEARFIL REPAIR 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.

#### 5. Statement of the intended use

The intended uses of this device are as follows. They are completely the same as CLEARFIL REPAIR manufactured by Kuraray Co., Ltd. (K001914).

- 1) Intraoral repairs of fractured porcelain or composite facing crowns/bridges
- 2) Intraoral repairs of fractured all ceramics restorations

3) Intraoral repairs of fractured porcelain and composite inlays/onlays

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- 6. Statement of the technological characteristics and safety
-

This device is essentially the same as CLEARFIL REPAIR manufactured by Kuraray Co., Ltd. Therefore the technological characteristics, chemical ingredients and safety of this (K001914). device are completely the same as CLEARFIL REPAIR.

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## SEP 1 3 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K012729

Trade/Device Name: Clearfil Repair Regulation Number: 872.3200 Regulation Name: Dental Light-Cured Repair Kit Regulatory Class: II Product Code: KLE Dated: August 9, 2001 Received: August 14, 2001

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.

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

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Page 2 - Ms. Sasaki

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 r ou intilet confirst war and 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 (section 531-542 of the Act; 21); CFR 1000-1050.

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 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 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,

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

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[CLEARFIL REPAIR, Kuraray Medical Inc.]

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: CLEARFIL REPAIR

#### Indications for Use

CLEARFIL REPAIR is indicated for the following applications:

1. Intraoral repairs of fractured porcelain or composite facing crowns/bridges.

2. Intraoral repairs of fractured all ceramics restorations.

3. Intraoral repairs of fractured porcelain and composite inlays/onlays.

(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 Runner

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital De 510(k) Number .