CLEARFIL PROTECT BOND

K033938 · Kuraray Medical, Inc. · KLE · Jan 29, 2004 · Dental

Device Facts

• Record ID: K033938
• Device Name: CLEARFIL PROTECT BOND
• Applicant: Kuraray Medical, Inc.
• Product Code: KLE · Dental
• Decision Date: Jan 29, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

The CLEARFIL PROTECT BOND device is indicated for the following applications: 1) direct restorations using light-cured composite resin or compomer 2) cavity sealing as a pretreatment for indirect restorations 3) treatment of hypersensitive and/or exposed root surfaces 4) intraoral repairs of fractured crowns/bridges made of porcelain, hybrid ceramics, or composite resin using light-cured composite resin 5) surface treatment of prosthetic appliances made of porcelain, hybrid ceramics, or cured composite resin 6) core build-ups using light- or dual-cured composite resin 7) cavity sealing under amalgam restorations ** For indications 1, 2, 3, 6, and 7 the device exhibits an antibacterial cavity cleansing effect.

Device Story

CLEARFIL PROTECT BOND is a resin-based dental adhesive system containing the antibacterial monomer 12-methacryloyloxydodecylpyridinium bromide (MDPB). Used by dental professionals in clinical settings for restorative procedures, the adhesive is applied to tooth surfaces or prosthetic materials. The device functions as a bonding agent while providing an antibacterial cavity cleansing effect. It facilitates adhesion for direct/indirect restorations, core build-ups, and repairs, and treats hypersensitivity. The inclusion of MDPB provides the antibacterial property, which benefits the patient by reducing bacterial presence in the cavity preparation. The device is applied directly by the clinician during standard dental procedures.

Clinical Evidence

No clinical trials were conducted. Evidence consists of bench testing demonstrating biocompatibility and efficacy of the MDPB ingredient as an antibacterial cavity cleanser compared to control groups of dental resin material without MDPB.

Technological Characteristics

Resin-based dental adhesive system containing 12-methacryloyloxydodecylpyridinium bromide (MDPB) as an antibacterial agent. The device is a chemical bonding agent used for dental restorative applications. No changes to composition from predicate K023842.

Indications for Use

Indicated for direct restorations (composite/compomer), cavity sealing for indirect restorations, treatment of hypersensitive/exposed root surfaces, intraoral repair of fractured crowns/bridges, surface treatment of prosthetic appliances, core build-ups, and cavity sealing under amalgam. Provides antibacterial cavity cleansing effect for most applications.

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

• Pulpdent Cavity Cleanser (K974202)
• Bisco Cavity Cleanser (K915668)
• Den-Mat Cavity Cleanser (K832497)
• Ultradent Consepsis Cavity Varnish (K925375)
• Ultradent Consepsis Cavity Varnish (K924982)

Reference Devices

• CLEARFIL SE BOND PLUS (K023842)

Submission Summary (Full Text)

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K033938

JAN 2 9 2004

## 510(k) SUMMARY Kuraray Medical Inc. CLEARFIL PROTECT BOND

### Name of Device

Trade or Proprietary Name: Common Name: Classification Name: Product Code:

CLEARFIL PROTECT BOND resin-based dental adhesive system resin tooth bonding agent 76KLE

#### Preparation Date

December 11, 2003

#### 510(k) Sponsor

Kuraray Medical Inc. 1621 Sakazu, Kurashiki, Okayama 710-8622 Japan

## 510(k) Sponsor Contact

Mr. Koji Nishida Kuraray America, Inc. 101 East 52"d Street 26th Floor New York, NY 10022 Phone: [phone] Fax: [phone]

#### Intended Use

CLEARFIL PROTECT BOND is a resin-based dental adhesive system. The device includes the antibacterial ingredient, 12-methacryloyloxydodecylpyridinium bromide (MDPB), as fully disclosed in the original filing for the device K#023842 (under the name CLEARFIL SE BOND PLUS). No changes are being made to the composition of the device. The only purpose of this 510(k) filing is to add the claim that the device also has an "antibacterial cavity cleansing effect."

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## Technological Characteristics and Substantial Equivalence

CLEARFIL PROTECT BOND is a resin-based dental adhesive system. The device includes the new antibacterial ingredient 12-methacryloyloxydodecylpyridinium bromide (MDPB), as fully disclosed in the original filing for the device K#023842 (under the name CLEARFIL SE BOND PLUS). No changes are being made to the composition of the device. The only purpose of this 510(k) filing is to add the claim that the device also has an "antibacterial cavity cleansing effect."

Substantial safety and efficacy testing has been conducted on the device, and specifically of the ingredient MDPB. Testing shows MDPB to be biocompatible, and also an effective antibacterial cavity cleanser compared to control groups of dental resin material without MDPB.

CLEARFIL PROTECT BOND is substantially equivalent for purposes of FDA market authorization to Pulpdent Cavity Cleanser (K#974202), Bisco Cavity Cleanser (K#915668), Den-Mat Cavity Cleanser (K#832497), and Ultradent Consepsis Cavity Varnish (K#925375 and K#924982). Although the CLEARFIL PROTECT BOND device has a different antibacterial ingredient (MDPB), the biocompatibility studies submitted with K#023842 demonstrate the safety of MDPB, and the efficacy studies submitted herewith demonstrate its effectiveness.

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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 & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of what appears to be three overlapping lines or strokes, possibly representing a human form or abstract design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JAN 2 9 2004

Kuraray Medical, Incorporated C/O Mr. Keith A. Barritt, Esq. Attorney Fish & Richardson P.C. 1425 K Street, N.W. Washington, District of Columbia 20005

Re: K033938

Trade/Device Name: CLEARFIL PROTECT BOND Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Codes: KLE and LBH Dated: December 18, 2003 Received: December 22, 2003

Dear Mr. Barritt:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becasin a reasy for any for any and and and if the referenced above and have determined are to tegally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate comments, or to that been reclassified in accordance with the for wreating Amendinens, of to devices that hart e est (Act) that do not require approval of a premarket the Federal Food, Drug, and Ocombile : 100 crefore, market the device, subject to the general approval application (1 Mr.). - The general controls provisions of the Act include controls provisions of the real - 110 gisting 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 if your device is classified (see above) into exactives. Existing major regulations affecting (PMA), it may be subject to such additions, Title 21, Parts 800 to 898. In your device can be found in the ecas nouncements concerning your device in the Ecderal Register.

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Page 2 - Mr. Keith A. Barritt, Esq.

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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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/dsma/dsmamain.html

Sincerely yours,

Tim S. Liao, Ph.D.

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

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K033939 510(k) Number (if known): Device Name: CLEARFIL PROTECT BOND Indications For Use:

> The CLEARFIL PROTECT BOND device is indicated for the following applications:

l ) direct restorations using light-cured composite resin or compomer

2) cavity sealing as a pretreatment for indirect restorations

3) treatment of hypersensitive and/or exposed root surfaces

4) intraoral repairs of fractured crowns/bridges made of porcelain, hybrid ceramics, or composite resin using light-cured composite resin

5) surface treatment of prosthetic appliances made of porcelain, hybrid ceramics, or cured composite resin

6) core build-ups using light- or dual-cured composite resin

7) cavity sealing under amalgam restorations

** For indications 1, 2, 3, 6, and 7 the device exhibits an antibacterial cavity cleansing effect.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V

(Per 21 CFR 801.109)

OR

Over-The-Counter Use

Susan Dunne

(Division Sign-Off) (Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: k003938