CLEARFIL PHOTO CORE PLT

K033970 · Kuraray Medical, Inc. · EBF · Mar 26, 2004 · Dental

Device Facts

• Record ID: K033970
• Device Name: CLEARFIL PHOTO CORE PLT
• Applicant: Kuraray Medical, Inc.
• Product Code: EBF · Dental
• Decision Date: Mar 26, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Core build up of vital or non vital tooth

Device Story

Clearfil Photo Core PLT is a light-cured composite resin restorative material used for core build-up of vital or non-vital teeth. It consists of materials such as bisphenol A glycidylmethacrylate (Bis-GMA). The device is supplied in disposable tips to facilitate application. It is intended for use by dental professionals in a clinical setting to restore structural defects in teeth. The material is cured using a dental light-curing unit. By providing a stable foundation for subsequent crown or bridge restorations, the device aids in the functional and structural rehabilitation of the tooth.

Clinical Evidence

No clinical data provided; substantial equivalence is based on chemical composition and technological characteristics compared to predicate devices.

Technological Characteristics

Dental composite resin restorative material containing Bis-GMA. Delivered via disposable tips. Light-cured. Class II device (21 CFR 872.3690).

Indications for Use

Indicated for core build-up of vital or non-vital teeth.

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 PHOTO CORE (K012705)
• CLEARFIL AP-X PLT (K023002)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image is a black and white logo. The logo features a stylized letter "K" with a geometric design. The letter is formed by a combination of straight lines and sharp angles, creating a modern and abstract look. The logo has a distressed or textured appearance, with small specks and imperfections scattered throughout, giving it a vintage or worn feel.

# KURARAY MEDICAL INC.

Quality Assurance Department Kuraray Nihonbashi Bldg. 3-1-6 Nihonbashi, Chuo-ku, Tokyo 103-82541 Phone : [phone] Facsimile: [phone]

MAR 2 6 2004

## 510(k) SUMMARY

| 1. Submitter | |
|----------------------|-----------------------------------------------------------------|
| 1) Name | KURARAY MEDICAL INC. |
| 2) Address | 1621 Sakazu, Kurashiki, Okayama 710-8622, Japan |
| 3) 1. Contact person | Masaya Sasaki<br>Dental Material Division, Kuraray Medical Inc. |

| 2. Contact person in U.S.A. | Satoshi Yamaguchi |
|-----------------------------|--------------------------------------|
| | Kuraray America Inc. |
| | 101 East 52nd Street, 26th Floor |
| | New York, NY 10022 |
| | Telephone: [phone] (Ext. 115) |
| | 1-(800)-879-1676 |
| | Facsimile: (212)-867-3543 |
| 4) Date | December 19, 2003 |

#### 2. Name of Device

| 1) Proprietary Name | CLEARFIL PHOTO CORE PLT |
|------------------------|-----------------------------------------------|
| 2) Classification Name | Tooth shade resin material (21CFR 872.3690) |
| 3) Common/Usual Name | Light-cured Composite Resin for Core Build Up |

#### 3. Predicate device

The predicate device is as follow;

- CLEARFIL PHOTO CORE manufactured by Kuraray Medical Inc. 1. (K012705)
- CLEARFIL AP-X PLT manufactured by Kuraray Medical Inc. ১। (K023002)
- 4. Description for the premarket notification

This product is classified into Tooth shade Resin Material, 21CFR Section 872,3690, because it is a device composed of materials such as bisphenol A glycidylmethacrylate (Bis-GMA) intended to restore carious or structural defects in teeth.

- 5. Statement of the intended use
The intended use of this device is as follows. It is the same as that of CLEARFIL PHOTO CORE (K012705).

- 1) Core build up of vital or non vital tooth
- 6. Statement of the technological characteristics and safety

This device is a dental composite resin restorative material. The composite resin is substantially equivalent to CLEARFIL PHOTO CORE (K012705) as the chemical composition, ingredients and intended use are the same as those of the predicate device. Also, this device is different from CLEARFIL PHOTO CORE (K012705) in that it is filled in disposable tips, but the disposable tips are substantially cquivalent to those that are used in CLEARFIL AP-X PLT (K012705).

Therefore this device is substantially equivalent in safety and technological characteristics as the predicate device.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

MAR 2 6 2004

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kuraray Medical Incorporated C/O Mr. Satoshi Yamaguchi Kuraray America, Incorporated 101 East 52nd Street, 26td Floor New York, New York 10022

Re: K033970

Trade/Device Name: Clearfil Photo Core PLT Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: December 19, 2003 Received: December 29, 2003

Dear Mr. Yamaguchi:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially cquivalent (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.

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Page 2 - Mr. Yamaguchi

Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be advised that 22 a determination that your device complies with other requirements 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 and listing (21 CFR Part 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 (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a promation hourseline 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), n you dontact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known): K033970

Device Name: Clearfil Photo Core PLT

Indications For Use: 1) Core bulld-up of vital or non-vital tooth

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suen Riinger

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(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number __