TOKUYAMA BOND FORCE

K070215 · Tokuyama Dental Corporation · KLE · Mar 30, 2007 · Dental

Device Facts

• Record ID: K070215
• Device Name: TOKUYAMA BOND FORCE
• Applicant: Tokuyama Dental Corporation
• Product Code: KLE · Dental
• Decision Date: Mar 30, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

TOKUYAMA BOND FORCE is a one-component, one-coat application, self-etching, light-cured, fluoride-releasing dental adhesive system. The adhesive can be cured using a light curing unit with a camphorquinone (CQ) wavelength range (400 - 500 mm range). The device is intended for the bonding of light- or dual-cured composite material to (i) cut or uncut enamel, (ii) cut or uncut dentin, or (iii) fractured porcelain or composite for repair.

Device Story

TOKUYAMA BOND FORCE is a one-component, self-etching, light-cured, fluoride-releasing dental adhesive. Applied by dental professionals to tooth structures (enamel/dentin) or restorative materials (porcelain/composite) to facilitate bonding of light- or dual-cured composite resins. Polymerization is triggered by a light curing unit (400-500 nm). Simplifies clinical workflow via one-coat application. Benefits include improved adhesion and fluoride release for dental restorations.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

One-component, self-etching, light-cured dental adhesive. Contains fluoride-releasing agents. Compatible with camphorquinone (CQ) light curing units (400-500 nm).

Indications for Use

Indicated for bonding light- or dual-cured composite materials to cut or uncut enamel, cut or uncut dentin, or fractured porcelain or composite for repair in dental patients.

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.

Submission Summary (Full Text)

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# (670215

## 510(k) SUMMARY Tokuyama Dental Corporation TOKUYAMA BOND FORCE

MAR 3 0 2007

#### Name of Device

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

TOKUYAMA BOND FORCE resin tooth bonding agent agent, tooth bonding, resin KLE

#### Preparation Date

January 10, 2007

#### 510(k) Sponsor

Tokuyama Dental Corporation 38-9 Taitou 1-chome, Taitou-ku Tokyo 110-0016 Japan

#### 510(k) Sponsor Contact

Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W., Suite 1100 Washington, DC 20005 Phone: [phone] Facsimile: [phone]

#### Intended Use

TOKUYAMA BOND FORCE is a one-component, one-coat application, self-etching, light-cured, fluoride-releasing dental adhesive system. The adhesive can be cured using a light curing unit with a camphorquinone (CQ) wavelength range (400 - 500 mm range). The device is intended for the bonding of light- or dual-cured composite material to (i) cut or uncut enamel, (ii) cut or uncut dentin, or (iii) fractured porcelain or composite for repair.

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### Technological Characteristics and Substantial Equivalence

The TOKUYAMA BOND FORCE device is substantially equivalent to multiple predicate devices with respect to biocompatibility, bond strength, and fluoride release rate. Although the TOKUYAMA BOND FOR.CE may have slightly different performance characteristics than the predicate devices, these differences do not raise new questions of safety or effectiveness.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tokuyama Dental Corporation C/O Mr. Robert A. Silverman Fish & Richardson P.C. 1425 K Street, N.W. Suite 1100 Washington, DC 20005

MAR 3 0 2007

Re: K070215

Trade/Device Name: TOKUYAMA BOND FORCE Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: January 22, 2007 Received: January 24, 2007

Dear Mr. Silverman:

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. Silverman

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,

Sylvia Y. Michieu Dms.

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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K070215

## Indications for Use

KU7C215 510(k) Number (if known): unknown

Device Name: TOKUYAMA BOND FORCE

Indications for Use:

The TOKUYAMA BOND FORCE resin tooth bonding agent device is intended for the bonding of light- or dual-cured composite material to (i) cut or uncut enamel, (ii) cut or uncut dentin, or (iii) fractured porcelain or composite for repair.

Prescription Use V (21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

Subey Rumer

nesiology, Ganeral Hr

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