CLEARFIL CORE NEW BOND

K012703 · Kuraray Medical, Inc. · EBF · Sep 10, 2001 · Dental

Device Facts

• Record ID: K012703
• Device Name: CLEARFIL CORE NEW BOND
• Applicant: Kuraray Medical, Inc.
• Product Code: EBF · Dental
• Decision Date: Sep 10, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Restoration where a self-cured adhesive composite for core build-up is required.

Device Story

CLEARFIL CORE NEW BOND is a self-cured adhesive composite resin used by dental professionals for core build-up procedures. The device is applied to tooth structures to restore missing tooth substance. It functions as a restorative material, providing a foundation for subsequent crown or bridge placement. The device is used in a clinical dental setting. It benefits patients by facilitating the reconstruction of damaged teeth, allowing for effective prosthetic restoration.

Clinical Evidence

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

Technological Characteristics

Self-cured adhesive composite resin. Contains bisphenol A glycidylmethacrylate (Bis-GMA). Classified as a tooth shade resin material (21 CFR 872.3690).

Indications for Use

Indicated for use as a self-cured adhesive composite resin for core build-up in dental restorations.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Predicate Devices

• CLEARFIL CORE NEW BOND by Kuraray Co., Ltd. (K871637)

Submission Summary (Full Text)

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[CLEARF!... CORE NEW BOND, Kuraray Medical Inc.J

Image /page/0/Picture/1 description: The image is a logo for Kuraray. The logo is a stylized letter "K" inside of a square. The word "KURARAY" is written below the letter "K".

Kita-ku, Osaka 530-8611, JAPAN

# SEP 1 0 2001

### 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,<br>NY 10166<br>Telephone : [phone]<br>1-(800)-879-1676<br>Facsimile : (212)-867-3543 |

#### 2. Name of Device

| 1) Proprietary Name | CLEARFIL CORE NEW BOND |
|------------------------|-------------------------------------------------------|
| 2) Classification Name | Tooth shade resin material |
| 3) Common/Usual Name | Self-cured adhesive composite resin for core build-up |

### 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.

- 1. CLEARFIL CORE NEW BOND by Kuraray Co., Ltd. (K871637)
- 4. Description for the premarket notification

This product is classified into Tooth shade resin material, CFR 29 Section 872.3690, because it is a device composed of materials such as bisphenol A glycidylmethacrylate (Bis-GMA) intended to be used for core build-up.

- 5. Statement of the intended use
The intended use of this device is as follow. They are completely the same as CLEARFIL CORE NEW BOND manufactured by Kuraray Co., Ltd. (K871637).

1) Restoration where a self-cured adhesive composite for core build-up is required.

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## 6. Statement of the technological characteristics and safety

This device is essentially the same as CLEARFIL CORE NEW BOND manufactured by Kuraray Co., Ltd. (K871637). Therefore the technological characteristics, chemical ingredients and safety of this device are completely the same as CLEARFIL CORE NEW BOND.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with the profiles overlapping each other. The profiles are positioned above three wavy lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

# SEP 1 0 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: K012703

Trade/Device Name: Clearfil Corc New Bond Regulation Number: 872.3690 Regulation Name: Self-Cured Adhesive Composite Resin For Core Build Up Regulatory Class: II Product Code: EBF 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 intendee comments, 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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of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I cocraf surates and regarents, including, but not limited to: registration You indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFRT in t 677), laceling (21 CFR Partialing (21 CFR Part 820); and if requirements as sectorul in alle quality of station 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) This letter will anow you to begin mailoring , but substantial equivalence of your device to a premarket notification. The PDA miding of cassification 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 II you desire specific advice to: youdiagnostic devices), please contact the Office of and additionally 809.10 for in Vitto attigate to the promotion and Compliance at [phone]. Friends contact the Office of Compliance at [phone]. advortibing or your the regulation entitled, "Misbranding by reference to premarket Also, prease note the regulation on and information on your responsibilities under the notification (21CFN 807.97). Other general in Manufacturers, International and Consumer Act may be obtained from the Dristiss as a 2011 or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

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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[CLEARFIL CORE NEW BOND, Kuraray Medical Inc.]

K012703

510(k) Number (if known): K012703

Device Name: CLEARFIL CORE NEW BOND

# Indications for Use

CLEARFIL CORE NEW BOND is indicated for the following application:
CLEARFIL CORE NEW BOND is indicated for the formers build was EARFIL CORE NWW DOND is material we care build-up is required. 1)

(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)

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

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