CLEARFIL DC ACTIVATOR; CLEARFIL DC ACTIVATOR TRIAL

K131430 · Kuraray Noritake Dental, Inc. · KLE · Aug 30, 2013 · Dental

Device Facts

• Record ID: K131430
• Device Name: CLEARFIL DC ACTIVATOR; CLEARFIL DC ACTIVATOR TRIAL
• Applicant: Kuraray Noritake Dental, Inc.
• Product Code: KLE · Dental
• Decision Date: Aug 30, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

When used with the CLEARFIL BONDING SYSTEM, the product is indicated for the following uses. [1] Core build-up in conjunction with self- or dual- cured core build-up materials [2] Cementation in conjunction with self- or dual- cured composite resin cements

Device Story

CLEARFIL DC Activator is a dental additive designed to enable the dual-curing mechanism of the CLEARFIL BONDING SYSTEM (e.g., CLEARFIL SE BOND 2 or CLEARFIL SE Protect). The activator is mixed with the bonding agent by a dental professional in a clinical setting. This mixture allows the bonding system to be compatible with self-cure or dual-cure composite resin cements and core build-up materials. By facilitating the polymerization process, the device ensures effective bonding during restorative procedures, ultimately benefiting the patient through improved retention and structural integrity of dental restorations.

Clinical Evidence

Bench testing only. Tensile bond strength to bovine enamel and bovine dentin was measured and compared to predicate devices. Results confirmed no significant difference in performance.

Technological Characteristics

Dental bonding activator liquid. Chemical composition is equivalent to predicate devices. Functions by initiating dual-curing mechanism in bonding systems. No international performance standards exist; performance validated via comparative bench testing of tensile bond strength.

Indications for Use

Indicated for dental patients requiring core build-up or cementation procedures using self- or dual-cured materials in conjunction with the CLEARFIL BONDING SYSTEM.

Regulatory Classification

Identification

A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.

Predicate Devices

• Self-Cure Activator (K050386)
• CLEARFIL NEW BOND (K012734)

Submission Summary (Full Text)

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[CLEARFIL DC Activator, Kuraray Noritake Dental Inc.] Section 3: Summary

> Date: June. 12, 2013

#### KIJI 430

### 510(k) Summary

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

I) Name

2) Address

3) Contact person

4) Contact person in US

Kuraray Noritake Dental Inc.

1621 Sakazu, Kurashiki, Okayama 710-0801, Japan

Michio Takigawa Quality Assurance Department

Goro Asanuma KURARAY AMERICA INC. 33 Maiden Lane, 6th Floor, New York, NY 10038 Tel: [phone] (Ext. 115) or (800)-879-1676 Fax: [phone]

**AUG** 3 0 2013

#### 3-2. Name of Device

1) Trade / Proprietary name

2) Classification name

CLEARFIL DC Activator

Agent Tooth Bonding, Resin (21 CFR section 872.3200. Product code: KLE)

Dental bonding agent

510(k) Number:

Classification:

Product Code:

21 CFR Section:

21 CFR Section:

Applicant:

#### 3-3. Predicate device

3) Common name

1) Self-Cure Activator

Applicant: 510(k) Number: 2) CLEARFIL NEW BOND Classification: Product Code:

K050386 Agent, Tooth Bonding, Resin KLE 872.3200 DENTSPLY INTERNATIONAL INC.

K012734 Agent, Tooth Bonding, Resin KLE 872.3200 Kuraray Noritake Dental Inc.

#### 3-4. Device Description

The subject device activates the dual-curing mechanism of the CLEARFIL BONDING SYSTEM (c.g. CLEARFIL SE BOND 2 or CLEARFIL SE Protect). The product is mixed with the BOND and can be used with dual-cure or self-cure composite filling materials, cements, or core build-up materials.

This is the new registration application for the subject device and there have not been any prior submissions regarding the subject device.

#### 3-5. Statement of Intended Use

When used with the CLEARFIL BONDING SYSTEM, the product is indicated for the following uses.

[1] Core build-up in conjunction with self- or dual- cured core build-up materials

[2] Cementation in conjunction with self- or dual- cured composite resin cements

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#### 3-6. Substantial Equivalence Discussion

- l) Intended uses
The intended use of the subject device was written up based on that of the predicate device. Therefore, the intended use of the subject device is substantially equivalent to that of the predicate device.

- 2) Chemical ingredients/ Safety
All ingredients in the subject device have been used in the predicate device. Regarding the predicate device, there have not been any reported problems or recalls according to the post market adverse event reporting requirements in the US. In conclusion, it can be said that the safety of the subject device is substantially equivalent to that of the predicate device.

- 3) Technological characteristics/ Effectiveness and Performance
Since there have not been any international standards concerning performance of this type of device, certain tests were performed on this device considering its intended use, in comparison with the predicate device.

As the result of testings. it was confirmed that each tensile bond strength of the subject device to bovine cnamel or bovine dentin was not significantly different or not less than that of the predicate device. Therefore, it was considered that the subject device was as effective as and performs as good as the predicate device.

In conclusion, it can be said that the effectiveness and performance of the subject device are substantially equivalent to those of the predicate device.

#### 3-7. Biocompatibility

The subject device is categorized into the external communicating device (tissue/ bone/ dentin) and permanent contact device.

All the chemical ingredients of the subject device are equivalent to those of the predicate device.

Regarding the predicate device, there have not been any reported problems or recalls according to the post-market adverse event reporting requirements in the US. Accordingly, it was considered that the subject device was substantially equivalent in safety to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

## August 30, 2013

Kuraray Noritake Dental, Inc. C/Q Mr. Goro Asanuma General Manger, Dental Materials Division Kuraray America, Incorporated 33 Maiden Lane, 6th Floor New York, NY 10038

Re: K131430

Trade/Device Name: Clearfil DC Activator Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Codes: KLE Dated: June 12, 2013 Received: June 14, 2013

Dear Mr. Asanuma:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), i it may be subject to 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. Asanuma

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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

For Kwame Ulmer

# Lester W. Schultheis Jr

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, 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): ___ K131430

Device Name: CLEARFIL DC Activator

Indications for Use:

When used with the CLEARFIL BONDING SYSTEM, the product is indicated for the following uses.

[1] Core build-up in conjunction with self- or dual- cured core build-up materials

[2] Cementation in conjunction with self- or dual- cured composite resin cements

Prescription Use _ V (Part 21 CFR 801 Subpart D)

AND/OR

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) Lauren M. Giles for AIS 2013.08.30 10:40:26 -04'00'

(Division Sign-Off) (Division Olgh Oly). General Hospital Infection Control, Dental Devices

510(k) Number: K131430