CLEARFIL CERAMIC PRIMER

K061906 · Kuraray Medical, Inc. · EBF · Sep 28, 2006 · Dental

Device Facts

• Record ID: K061906
• Device Name: CLEARFIL CERAMIC PRIMER
• Applicant: Kuraray Medical, Inc.
• Product Code: EBF · Dental
• Decision Date: Sep 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2

Intended Use

1) Surface treatment of porcelain, ceramics, hybrid ceramics or composite resin 2) Intraoral repairs of fractured crowns/bridges made of porcelain, ceramics, hybrid ceramics or composite resin

Device Story

CLEARFIL CERAMIC PRIMER is a silane-coupling agent used by dental professionals to enhance the adhesive surface of porcelain, ceramics, hybrid ceramics, or composite resin. Applied during clinical procedures, the primer facilitates bonding for intraoral repairs of fractured crowns and bridges. By chemically modifying the substrate surface, it improves bond strength between the restorative material and adhesive systems. The device is intended for professional use in a dental clinic setting to improve the longevity and success of dental restorations.

Clinical Evidence

Bench testing only. Evidence consists of tensile bond strength tests comparing the subject device to predicate devices, demonstrating equivalent or superior performance.

Technological Characteristics

Silane-coupling agent. Chemical composition is consistent with previously cleared dental bonding agents. No specific materials standards, energy sources, or software components are described.

Indications for Use

Indicated for surface treatment and intraoral repair of fractured crowns and bridges composed of porcelain, ceramics, hybrid ceramics, or composite resin.

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 PORCELAIN BOND ACTIVATOR (K012730)
• CLEARFIL SE BOND (K012442)
• CLEARFIL TRI-S BOND (K042913)
• MONOBOND S (K905220)

Submission Summary (Full Text)

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[CLEARFIL CERAMIC PRIMER, KURARAY MEDICAL INC.]
Section 3: Summary

K061906

Image /page/0/Picture/1 description: The image is a logo for Kuraray. The logo is a black square with a white stylized letter "K" inside. The word "KURARAY" is printed in white letters below the square. The logo is simple and modern.

## JRARAY MEDICAL. INC.

### Quality Assurance Department

1-1-3 Otemachi, Chiyoda-ku, Tokyo, 100-0000 : [phone] Phone Facsimile: [phone]

SEP 2 8 2006

Date: June 30, 2006

## 510(k) Summary

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

- 1) Name
2) Address

3) Contact person

4) Contact person in U.S.

1604.0 K 1141.0 710.0

1621 Sakazu, Kurashiki, Okayama 710-0801, Japan

Michio Tukigawa Quality Assurance Department

KURARAY MEDICAL INC.

Koji Nishida KURARAY AMERICA INC. 101 East 52nd Street, 26th Floor New York, NY 10022 Tel: [phone] (Ext. 115) or (800)-879-1676 Fax: [phone]

#### 3-2. Name of Device

2) Classification name

CLEARFIL CERAMIC PRIMER 1) Trade / Proprietary name

> Resin tooth bonding agent (21 CFF): section 872.3200. Product code: KLE)

Silane coupling agent

#### 3-3. Predicate device

3) Common name

1) CLEARFIL PORCELAIN 510(k) Number: K012730 Product Code: BOND ACTIVATOR KLE 21 CFR Section: 872.3200 Applicant: KURARAY MEDICAL INC. 2) CLEARFIL SE BOND 510(k) Number: K012442 Product Code: KLE 872.3200 21 CFR. Section: Applicant: KURARAY AMERICA, INC. 510(k) Number: K042913 3) CLEARFIL TRI-S BOND Product Code: KLE 21 CFR Section: 872.3200 Applicant: KURARAY COMPANY, LTD. 510(k) |Number: K905220 4) MONOBOND S Product Code: EBF 21 CFR Section: 872.3690 IVOCLAR NORTH AMERICA, INC. Applicant:

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#### 3-4. Description of device

CLEARFIL CERAMIC PRIMER is a silane-coupling agent that provides an enhanced adhesive surface to porcelain, ceramics, hybrid ceramics or composite resin.

at is intended to be used for the indications listed in the right 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) Surface treatment of porcelain,<br>ceramics, hybrid ceramics or composite<br>resin | - MONOBOND S<br>- CLEARFIL SE BOND (not indicating ceramics)<br>- CLEARFIL TRI-S BOND and CLEARFIL<br>PORCELAIN BOND ACTIVATOR (not<br>indicating ceramics or hybrid ceramics) |
| 2) Intraoral repairs of fractured<br>crowns/bridges made of porcelain,<br>ceramics, hybrid ceramics or composite<br>resin | - MONOBOND S<br>- CLEARFIL SE BOND (not indicating ceramics)<br>- CLEARFIL TRI-S BOND and CLEARFIL<br>PORCELAIN BOND ACTIVATOR (not<br>indicating ceramics or hybrid ceramics) |

## 3-5. Technological characteristics of device

It can be said that the applicant device is as safe as, as effective, and performs as well as or better than the predicate devices with the followings:

- 1) Chemical ingredients
All the chemical ingredients of the applicant device have been used in the predicate devices indicating that the safety of the applicant device is substantially equivalent to the predicate devices.

- 2) Effectiveness / Performance
Tensile bond strength tests on the applicant device in comparison to the predicate devices Tellshe bond sheight tests on the appass effective and performs as well as or better than the predicate devices.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 8 2006

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

Re: K061906

Trade/Device Name: Clearfil Ceramic Primer Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: EBF Dated: June 30, 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 cither 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.

Snette Y. Michum Omd.

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

\$661906 510(k) Number (if known):

Device Name: ________________________________________________________________________________________________________________________________________________________________

Indications for Use:

- 1) Surface treatment of porcelain, ceramics, hybrid ceramics or composite resin
- 2) Intraoral repairs of fractured crowns/bridges made of porcelain, ceramics,

hybrid ceramics or composite resin

Prescription Use _____________________________________________________________________________________________________________________________________________________________ X AND/C) R (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 Runner

nesthesiology. General Hospital. Control. Dental E