CLEARFIL ST OPAQUER

K012704 · Kuraray Medical, Inc. · EBF · Sep 10, 2001 · Dental

Device Facts

• Record ID: K012704
• Device Name: CLEARFIL ST OPAQUER
• 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

Indications for Use

1) Masking of metal during intraoral repair of porcelain fused-to-metal crowns. 2) Masking of metal in restoration of post and core crowns. 3) Lightening of stained or discolored teeth in porcelain or composite veneer restorations. 4) Masking of pulp capping materials.

Device Story

CLEARFIL ST OPAQUER is a dental composite resin used by dentists for masking metal or discolored tooth structures. The device is applied intraorally to mask metal during porcelain fused-to-metal crown repairs, mask metal in post and core restorations, lighten stained teeth, or cover pulp capping materials. It functions as an opaque restorative material to improve aesthetic outcomes in dental procedures. The device is identical to the predicate CLEARFIL ST OPAQUER (K001913), with this submission reflecting only a change in manufacturer name and address from Kuraray Co., Ltd. to Kuraray Medical Inc.

Clinical Evidence

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

Technological Characteristics

Dental composite resin containing bis-GMA (bisphenol-A glycidylmethacrylate). The device is a light-cured restorative material used for masking. Technological characteristics, chemical ingredients, and safety profile are identical to the predicate device.

Indications for Use

Indicated for masking metal in intraoral repair of porcelain fused-to-metal crowns, masking metal in post and core crown restorations, lightening stained or discolored teeth in porcelain or composite veneer restorations, and masking pulp capping materials.

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 ST OPAQUER (K001913)

Submission Summary (Full Text)

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#### DICAL INC. JRARAY MEC ental Material Department

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1-Chome, Umeda, Kita-ku, Osaka 530-8611, JAPAN [phone] Facsimile: [phone]

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# 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 ST OPAQUER |
|------------------------|---------------------------------------------|
| 2) Classification Name | Tooth Shade resin Material (21CFR 872.3690) |
| 3) Common/Usual Name | Dental composite resin for masking |

#### 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.

- CLEARFIL ST OPAQUER by Kuraray Co., Ltd. (K001913) 1.
- 4. Description for the premarket notification

CLEARFIL ST OPAQUER is classified into the Tooth Shade Resin Material, CFR 21 Section bisphenol-A because it is a device composed of materials such as 872.3690. glycidylmethacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

#### 5. Statement of the intended use

The intended uses of this device are as follows. They are completely the same as CLEARFIL ST OPAQUER manufactured by Kuraray Co., Ltd. (K001913).

- 1) Masking of metal during intraoral repair of porcelain fused-to-metal crowns.
- 2) Masking of metal in restoration of post and core crowns.

3) Lightening of stained or discolored teeth in porcelain or composite veneer restorations.

4) Masking of pulp capping materials.

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### 6. Statement of the technological characteristics and safety

This device is essentially the same as CLEARFIL ST OPAQUER manufactured by Kuraray Co., Ltd. (K001913). Therefore the technological characteristics, chemical ingredients and safety of this device are completely the same as CLEARFIL ST OPAQUER.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 0 2001

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

Re: K012704

Trade/Device Name: Clearfil ST Opaquer Regulation Number: 872.3690 Regulation Name: Dental Composite Resin For Masking 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 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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of the Act or any Federal statutes and regulations administered by other Federal agencies. of the Act of ally I oderal cannotes as requirements, including, but not limited to: registration Tour must comply with and are labeling (21 CFR Part 801); good manufacturing practice and listing (21 CF RT rat 807), labeling (25) regulation (21 CFR Part 820); and if requirements as Sectionic 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) I mis letter will and w your of substantial equivalence of your device of your device to a premitset notification. - The Pere 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 If you dosire specific and for in vitro diagnostic devices), please contact the Office of and additionally 0091194-4613. 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 notification (21011 16 0079). Outsi good Small Manufacturers, International and Consumer Act may be obtained from the Dristen [phone] 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 ST OPAQUER , Kuraray Medical Inc.]

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510(k) Number (if known): KD12704

Device Name: CLEARFIL ST OPAQUER

### Indications for Use

CLEARFIL ST OPAQUER is indicated for the following applications:

- Masking of metal during intraoral repair of porcelain fused-to-metal crowns. 1)
- Masking of metal in restoration of post and core crowns. 2)
- Lightening of stained or discolored teeth in porcelain or composite veneer restorations. 3)
- Masking of pulp capping materials. 4)

### (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 Runne

(Division Sign-Off) (Division Sign-On))
Division of Dental, Infection Control, Division of General Hospital D 515(k) Number -