CLEARFIL MAJESTY POSTERIOR

K063595 · Kuraray America, Inc. · EBF · Feb 9, 2007 · Dental

Device Facts

• Record ID: K063595
• Device Name: CLEARFIL MAJESTY POSTERIOR
• Applicant: Kuraray America, Inc.
• Product Code: EBF · Dental
• Decision Date: Feb 9, 2007
• 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 I - V cavities) 2) Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.) 3) Intraoral repairs of fractured crowns/bridges

Device Story

CLEARFIL MAJESTY Posterior is a light-cure, radiopaque restorative composite resin; used by dental professionals in clinical settings for direct tooth restorations and repairs. Formulated with Bis-GMA; provides color matching, polishability, and physical properties for anterior and posterior applications. Applied intraorally by clinicians; cured using dental light-curing equipment. Benefits include structural restoration of tooth anatomy and aesthetics.

Clinical Evidence

Bench testing only. Device performance verified through compliance with ISO 4049:2000 (Dentistry - Polymer-based filling, restorative and luting materials). No clinical data provided.

Technological Characteristics

Light-cure, radiopaque restorative composite resin. Composition includes Bis-GMA. Classified as Type 1, Class 2, Group 1 material per ISO 4049:2000. Requires intraoral light energy for polymerization.

Indications for Use

Indicated for patients requiring direct restorations of anterior and posterior teeth (Class I-V cavities), correction of tooth position or shape (e.g., diastema closure, dwarfed teeth), and intraoral repair of fractured crowns or 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 (K012740)
• ESTENIA C&B (K042929)
• CLEARFIL LINER BOND 2 (K943170)
• TETRIC FLOW (K993783)
• CLEARFIL SE BOND (K012442)
• CLEARFIL ST OPAQUER (K012704)

Submission Summary (Full Text)

{0}------------------------------------------------

[CLEARFIL MAJESTY Posterior, KURARAY MEDICAL INC.] Section 3: 510(k) Summary

K063595

Date: December 1, 2006

## 510(k) Summary

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

- l) Name
- 2) Address
- 3) Contact person

4) Contact person in U.S.

FEB 9 2007

#### KURARAY MEDICAL INC.

1621 Sakazu, Kurashiki, Okayama 710-0801. Japan

Micho Takigawa Quality Assurance Department

CLEARFIL MAJESTY Posterior

Tooth shade resin material

(Listing Number: R001413) Restorative composite resin

Koji Nishida KURARAY AMERICA INC. 600 Laxington Avenue, 26th Floor New York, NY 10022 Tel: [phone] (Ext. 115) or (800)-879-1676 Fax: { 212)-867-3543

(21 CFR section 872.3690. Product code: EBF)

#### 3-2. Name of Device

1) Trade / Proprietary name 2) Classification name

3) Common name

#### 3-3. Predicate device

510(k) Number: K061860 1) CLEARFIL MAJESTY Esthetic Tooth shade resin material Classification: Product Code: EBF 21 CFR Section: 872.3690 KURARAY MEDICAL INC. Applicant: 510(k) Number: K012740 2) CLEARFIL AP-X Classification: Tooth Shade Resin Material EBF Product Code: 21 CFR Section: 872.3690 KURARAY MEDICAL INC. Applicant: 510(k) Number: K042929 3) ESTENIA C&B Classification: Tooth shade resin material Product Code: EBF 21 CFR Section: 872.3690 KURARAY MEDICAL. INC. Applicant: 510(k) Number: K943170 4) CLEARFIL LINER BOND 2 Resin tooth bonding agent Classification: Product Code: KLE 872.3200 2 . CFR Section: KURARAY MEDICAL INC. Applicant: 510(k) Number: K993783 5) TETRIC FLOW Classification: Tooth shade resin material Froduct Code: EBF 1 CFR Section: 872.3690 IVOCLAR NORTH AMERICA, INC. Applicant:

{1}------------------------------------------------

| 6) CLEARFIL SE BOND | 510(k) Number: | K012442 |
|------------------------|-----------------|----------------------------|
| | Classification: | Resin tooth bonding agent |
| | Product Code: | KLE |
| | 21 CFR Section: | 872.3200 |
| | Applicant: | KURARAY MEDICAL INC. |
| 7) CLEARFIL ST OPAQUER | 510(k) Number: | K012704 |
| | Classification: | Tooth shade resin material |
| | Product Code: | EBF |
| | 21 CFR Section: | 872.3690 |
| | Applicant: | KURARAY MEDICAL INC. |

#### 3-4. Device Description

- 1) CLEARFIL MAJESTY Posterior 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.
- 2) 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-( Y -methacryloxy- 3 -hydroxypropoxy) phenyl] propane (Bis-GMA).
- 3) According to the applicable FDA recognized consensus standard, ISO 4049: 2000 "Dentistry - Polymer-based filling, res orative 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; -
- Group 1: materials whose use requires the energy to be applied intra-orally. -

#### 3-5. Substantial Equivalence Discussion

#### 1) 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<br>posterior teeth (Class I - V cavities) | CLEARFIL MAJESTY Esthetic,<br>CLEARFIL AP-X |
| 2) Correction of tooth position and tooth<br>shape (e.g. diastema closure, dwarfed<br>tooth, etc.) | CLEARFIL MAJESTY Esthetic |
| 3) Intraoral repairs of fractured<br>crowns/bridges | CLEARFIL MAJESTY Esthetic |

### 2) Chemical ingredients / Safety

All the chemical ingredients of CLEARFIL MAJESTY Posterior, the applicant device, have been used in the predicate devices inclicating that the safety of the applicant device is substantially equivalent to the predicate devices.

### 3) Effectiveness / Performance

CLEARFIL MAJESTY Posterior, 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 the predicate devices according to ISO 41/49: 2000, the applicant and the predicate devices comply with ISO 4049: 2000 indicating that the applicant device is as effective as and

{2}------------------------------------------------

#### 3-6. Biocompatibility

All the chemical ingredients of CLEARFIL MAJESTY Posterior, the applicant device, have been used in the predicate devices as shown in the tables of "Section 7: Substantial Equivalence Discussion, Table: 7-2" where all the chemical ingredients of the applicant device are listed in the right hand column and the predicate devices containing the ingredient are listed in the left hand. All the chemical ingredients do not contains a "new" or nonconventional chemical component. From that table, it can be said that the safety of the applicant device is substantially equivalent to the predicate devices.

{3}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/10 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the emblem.

3 2017

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Koji Nishida General Manager Kuraray America, Incorporated 600 Lexington Avenue, 26th Floor New York, New York 10022

Re: K063595

Trade/Device Name: CLEARFIL MAJESTY Posterior Regulation Number: 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: December 1, 2006 Received: December 12, 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.

{4}------------------------------------------------

#### 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.

Susan R.
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

{5}------------------------------------------------

# Indications for Use

510(k) Number (if known): _ 0 6 3 5 9 5

Device Name: _CLEARFIL MAJESTY Posterior

Indications for Use:

- 1) Direct restorations for anterior and posterior teeth (Class I V cavities)
- 2) Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.)
- 3) 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 IIF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Russo

on of Anesthesiology, General Hospi Infection Control, Dental D

510(k) Number: K063516