CLEARFIL MAJESTY ESTHETIC

K061860 · Kuraray Medical, Inc. · EBF · Sep 18, 2006 · Dental

Device Facts

• Record ID: K061860
• Device Name: CLEARFIL MAJESTY ESTHETIC
• Applicant: Kuraray Medical, Inc.
• Product Code: EBF · Dental
• Decision Date: Sep 18, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1) Direct restorations for anterior and posterior teeth (Class 1 - 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

Device Story

CLEARFIL MAJESTY Esthetic is a light-cure, radiopaque restorative composite resin; used by dental professionals for direct tooth restorations and repairs. Device provides color matching, polishability, and handling characteristics; formulated with Bis-GMA resin. Applied intraorally by clinicians; light-cured to achieve setting. Benefits include restoration of tooth structure and aesthetics; correction of dental morphology.

Clinical Evidence

Bench testing only. Device verified to comply with ISO 4049:2000 standards for polymer-based filling, restorative, and luting materials. No clinical data provided.

Technological Characteristics

Light-cure, radiopaque restorative composite resin. Composition includes 2,2'-Bis-[p-(7-methacryloxy-3-hydroxypropoxy) phenyl] propane (Bis-GMA). Classified as Type 1, Class 2 material per ISO 4049:2000. Energy source: intraoral light-curing unit.

Indications for Use

Indicated for direct restorations of anterior and posterior teeth (Class I-V cavities), 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 AP-X (K012740)
• EPRICORD (K033267)
• GRADIA DIRECT (K023814)
• TETRIC EVOCERAM (K042819)

Submission Summary (Full Text)

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[CLEARFIL MA.JESTY Esthetic, KURARAY MEDICAL INC.] Section 3: Summary

SEP 1 8 2006

### Quality Assurance Department

1-1-3 Otemachi, Chiyoda-ku, Tokyo, 100-00044 : [phone] Phone Facsimile: [phone]

Date: June 28, 2006

# 510(k) Summary

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

- 1) Name
2) Address

3) Contact person

4) Contact person in U.S.

1621 Sakazu, Kurashiki, Okayama 710-0801, Japan

Michio Takigawa Quality A surance Department

KURARAY MEDICAL INC.

Koji Nishida KURARAY AMERICA INC. 101 East #2nd Street, 26th Floor New York, NY 10022 Tel: [phone] (Ext. 115) or (800)-879-1676 Fax: [phone]

#### 3-2. Name of Device

| 1) Trade / Proprietary name | CLEARFIL MAJESTY Esthetic |
|-----------------------------|----------------------------|
| 2) Classification name | Tooth shade resin material |

Tooth shade resin material (21 CFR section 872.3690. Product code: EBF)

Restorative composite resin

#### 3-3. Predicate device

3) Common name

K012740 510(k) Number: 1) CLEARFIL AP-X EBF Product Code: 872.3690 21 CFR Section: KURARAY MEDICAL INC. Applicant: K033267 510(k) Number: 2) EPRICORD Product Code: EBF 872.3690 21 CFR Section: KURARAY MEDICAL INC. Applicant: 510(k) Number: K023814 3) GRADIA DIRECT EBF Product Code: 21 CFR Section: 872.3690 GC AMERICA, INC. Applicant: 510(k) Number: K042819 4) TETRIC EVOCERAM Product Code: EBF 872.3690 21 CFR Section: IVOCLAR VIVADENT, INC. Applicant:

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# 3-4. Description of device

CLEARFIL MAJESTY Esthetic is a light-cure, radiopaque restorative composite resin which CLEARFIL MAJESTY ESInetic is a lign=cuts; futtopaqle veellent physical properties, making
provides accurate color matching, high polish ability and excellent provides and ing provides accurate color matering, mga ponon assimily is formulated with optimal viscosity assuring easy handling and placement.

It is classified into tooth shade resin material (21 CFR section 872.3690, Product code: EBF ) according to 21 CFR § 872 since it is composed of materials such as

2, 2'-Bis-[p-( 7 -methacryloxy- 3 -hydroxypropoxy) phenyl] propane (Bis-GMA).

According to the applicable FDA recognized consensus standard, ISO 4049, 2000 According to the applicable i Brilling, restorative and luting materials", this device is classified into the following:

- Type 1: polymer-based filling and restorative materials; ..
- Class 2: materials whose setting is effected by light; -
- Class 2. materials whose secting is the energy to be applied intra-orally. 『

#### 3-5. Intended uses

It is intended to be used for the indications listed in the left hand column of the below table that are equivalent to the predicate devices.

Table 3: Indications for Use and predicate devices

| Indications for Use | Predicate devices |
|-------------------------------------------------------------------------------------------------|--------------------------------------------------|
| 1) Direct restorations for anterior and posterior<br>teeth (Class 1 - V cavities) | CLEARFIL AP-X, TETRIC EVOCERAM,<br>GRADIA DIRECT |
| 2) Direct veneers | TETRIC EVOCERAM, GRADIA DIRECT |
| 3) Correction of tooth position and tooth shape<br>(e.g. diastema closure, dwarfed tooth, etc.) | GRADIA DIRECT |
| 4) Intraoral repairs of fractured crowns/bridges | TETRIC EVOCERAM |

### 3-6. Technological characteristics of device

#### 1) Effectiveness / Performance

CLEARFIL MAJESTY Esthetic, the applicant device, is verified to comply with the CLEARFIL MAJESTY Estibelte, the upplicatio consensus standard, ISO 4049. 2000. "Dentistry - Polymer-based filling, restorative and Juting materials". As to compare with "Dentistry - Polymer-Dased Ining, restorative and the pplice of and the predicate the predicate devices according to 1000 indicating that the applicant device is as effective as and performs as well as the predicate devices.

### 2) Chemical ingredients

All the chemical ingredients of CLEARFIL MAJESTY Esthetic, the applicant device, All the chemical ingredicate devices indicating that the safety of the applicant device is substantially equivalent to the predicate devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# SEP 1 8 2006

Kuraray Medical, Incorporated C/O Mr. Koji Nishida General Manager Kuraray America, Incorporated 101 East 52"d Street, 26th Floor New York, New York 10022

Rc: K()61860

Trade/Device Name: CLEARFIL MAJESTY Esthetic Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: June 28, 2006 Received: July 11, 2006

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. 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 (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 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" (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/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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): _

Device Name: _CLEARFIL MAJESTY Esthetic

Indications for Use:

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

Prescription Use _____________________________________________________________________________________________________________________________________________________________ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------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)

Susan Quares

-Off)
Anesthesiology, General Hospital,
Control, Dental Devices
Kala/Ka

Number: K0614