CLEARFIL MAJESTY ESTHETIC PLT

K070325 · Kuraray Medical, Inc. · EBF · Mar 21, 2007 · Dental

Device Facts

• Record ID: K070325
• Device Name: CLEARFIL MAJESTY ESTHETIC PLT
• Applicant: Kuraray Medical, Inc.
• Product Code: EBF · Dental
• Decision Date: Mar 21, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CLEARFIL MAJESTY Esthetic PLT is indicated for the following uses: Direct restorations for anterior and posterior teeth (Class I V cavities) . Direct veneers . Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.) . Intraoral repairs of fractured crowns/bridges

Device Story

CLEARFIL MAJESTY Esthetic PLT is a light-cure, radiopaque restorative composite resin. It is supplied in pre-loaded tips (PLT) for direct intraoral placement into dental cavities. The device is used by dental professionals in a clinical setting to restore tooth structure, correct shape or position, and repair fractured dental prosthetics. The material provides color matching, polishability, and physical properties suitable for anterior and posterior restorations. The primary benefit is the convenient, direct-dispensing delivery system compared to traditional syringe-based application.

Clinical Evidence

Bench testing only. The device was verified to comply with ISO 4049:2000 (Dentistry - Polymer-based filling, restorative and luting materials). No clinical data was required or provided.

Technological Characteristics

Light-cure, radiopaque restorative composite resin. Complies with ISO 4049:2000. Delivered via pre-loaded tips (PLT).

Indications for Use

Indicated for direct restorations of Class I-V cavities in anterior and posterior teeth, direct veneers, correction of tooth position and shape (e.g., diastema closure, dwarfed teeth), and intraoral repair of fractured crowns/bridges.

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 MAJESTY Esthetic (K061860)
• CLEARFIL AP-X PLT (K023002)

Submission Summary (Full Text)

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Section 3: Summary

K070325

Date: February 2, 2007

# 510(k) Summary

### 3-1. 510(k) owner (submitter)

MAR 2 1 2007

| 1) Name | KURARAY MEDICAL INC. |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2) Address | 1621 Sakazu, Kurashiki, Okayama 710-0801, Japan |
| 3) Contact person | Michio Takigawa<br>Quality Assurance Department |
| 4) Contact person in U.S. | Koji Nishida<br>KURARAY AMERICA INC.<br>600 Lexington Avenue, 26th Floor<br>New York, NY 10022<br>Tel: [phone] (Ext. 115) or (800)-879-1676<br>Fax: [phone] |
| 3-2. Name of Device | |
| 1) Trade / Proprietary name | CLEARFIL MAJESTY Esthetic PLT |
| 2) Classification name | Tooth shade resin material<br>(21 CFR section 872.3690. Product code: EBF) |
| 3) Common name | Restorative composite resin |
| 4) Device listing number | R001413 |
| 3-3. Predicate device | |
| 1) CLEARFIL MAJESTY Esthetic | 510(k) Number: K061860<br>Classification: Tooth shade resin material<br>(21 CFR section 872.3690. Product code: EBF)<br>Applicant: KURARAY MEDICAL INC. |
| 2) CLEARFIL AP-X PLT | 510(k) Number: K023002<br>Classification: Tooth shade resin material<br>(21 CFR section 872.3690. Product code: EBF)<br>Applicant: KURARAY MEDICAL INC. |

### 3-4. Description of device

CLEARFIL MAJESTY Esthetic PLT (PLT: Pre-loaded tip) is a light-cure, radiopaque restorative composite resin which provides accurate color matching, high polish ability and excellent physical properties, making it ideal for both anterior and posterior restorations. It is formulated with optimal viscosity assuring easy handling and placement. CLEARFIL MAJESTY Esthetic PLT, with its special dispensing system, can be quickly and conveniently placed directly into the cavity.

CLEARFIL MAJESTY Esthetic PLT, the applicant device, is substantially the same as CLEARFIL MAJESTY Esthetic, the predicate device where the only difference is the container form; the applicant device comes in tips while the predicate device is filled in syringes. The tips used in the applicant device are the same as those used in CLEARFIL AP-X PLT, the predicate device. Therefore, the applicant device is substantially equivalent to the predicate devices.

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#### 3-5. Intended uses

CLEARFIL MAJESTY Esthetic PLT is indicated for the following uses:

- Direct restorations for anterior and posterior teeth (Class I V cavities) י
- . Direct veneers
- -Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.)
- . Intraoral repairs of fractured crowns/bridges

The intended uses of CLEARFIL MAJESTY Esthetic PLT are exactly the same as those of CLEARFIL MAJESTY Esthetic.

## 3-6. Technological characteristics of device

#### 1) Safety

The chemical ingredients and the composition of CLEARFIL MAJESTY Esthetic PLT, the applicant device, are exactly the same as those in CLEARFIL MAJESTY Esthetic, the predicate device suggesting the safety of the applicant device is substantially equivalent to the predicate device.

#### 2) Effectiveness / Performance

CLEARFIL MAJESTY Esthetic PLT, the applicant device, is verified to comply with the requirements of the applicable FDA recognized consensus standard, ISO 4049: 2000 "Dentistry -Polymer-based filling, restorative and luting materials". As to compare with CLEARFIL MAJESTY Esthetic, the predicate device, according to ISO 4049: 2000, both the applications the predicate devices comply with the standard indicating the applicant device is as effective and performs as well as the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.

ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Kurarav Medical, Incorporated C/O Mr. Koji Nishida Kuraray America, Incorporated 600 Lexington Avenue, 26th Floor New York, New York 10022

MAR 2 1 2007

Re: K070325

Trade/Device Name: CLEARFIL MAJESTY™ Esthetic PLT Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: February 02, 2007 Received: February 07, 2007

Dear Mr. Nishida:

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.

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Page 2 - Mr. Koji Nishida

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 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 (OS) 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 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/industry/support/index.html.

Sincerely yours,

Clubs

Chiu S. Lin. PhD 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

L070325

510(k) Number (if known):

Device Name: CLEARFIL MAJESTY Esthetic PLT

Indications for Use:

CLEARFIL MAJESTY Esthetic PLT is indicated for the following restorative applications:

- 1) Direct restorations for anterior and posterior teeth (Class I V cavities)
- 2) Direct veneers
- 3) Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.)
- 4) Intraoral repairs of fractured crowns/bridges

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

Over-The-Counter Use N/A (21 CFR 801 Subpart C)

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

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Reberzons for Dr. Susan Runner

K070325

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