TOKUYAMA ONE-UP-BOND F

K993917 · Tokuyama America, Inc. · KLE · Feb 2, 2000 · Dental

Device Facts

• Record ID: K993917
• Device Name: TOKUYAMA ONE-UP-BOND F
• Applicant: Tokuyama America, Inc.
• Product Code: KLE · Dental
• Decision Date: Feb 2, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

For use in dental procedures as a bonding primer with light cured resin filling material to enhance the adhesion of resin filling material to the tooth and for sealing of exposed cervical dentin and root surfaces.

Device Story

One-Up Bond F is a resin tooth bonding agent used by dental practitioners in clinical settings. It functions as a primer to enhance the adhesion of light-cured composite resins to tooth structure and to seal exposed cervical dentin and root surfaces. The device is applied manually by the clinician during restorative dental procedures. It facilitates the bonding process, potentially improving the longevity and integrity of dental restorations and protecting exposed root surfaces.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Resin-based dental bonding agent. Chemical composition designed for light-cured resin adhesion and dentin sealing. Applied as a primer. No specific materials standards or software components described.

Indications for Use

Indicated for use by dental practitioners as a bonding primer with light-cured resin filling materials to improve adhesion to tooth structure and to seal exposed cervical dentin and root surfaces.

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

• Tokuso Mac Bond II (K980058)

Submission Summary (Full Text)

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## 2 2000 FEB

K993917

## 510(k) Summary

Submitted by: Daniel J. Manelli Farkas & Manelli, P.L.L.C. 2000 M Street, NW (Suite 700) Washington, DC 20036 Telephone: [phone]

> On behalf of Tokuyama America, Inc. 510(k) Submission: One-Up Bond F November 17, 1999

The product is a resin tooth bonding agent for use with Tokuyama's Tokuso Estelite or other types of light cured composite resins to enhance the bonding of these materials to the tooth and for sealing of exposed cervical dentin and root surfaces.

The product is for use only by dental practitioners; it is not intended for OTC use. It contains materials that pose no health hazard when used according to directions and has received the approval of the Japanese Government. The product is substantially equivalent to various marketed bonding agents, including Tokuyama's Tokuso Mac Bond II (K980058).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 2000

Mr. Daniel J. Manelli, Esquire Farkas & Manelli PLLC Attorneys 2000 M Street N.W., 7th Floor Washington, D.C. 20036-3307

Re : K993917

> Tokuyama America - One-Up-Bond F Trade Name: Requlatory Class: II Product Code: KLE Dated: January 20, 2000 Received: January 21, 2000

Dear Mr. Manelli:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any

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Paqe 2 - Mr. Manelli

obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K993917

Page _ 1__ of _ 1

510{k) Number (if known): K993917

Device Name:

Indications For Use:

For use in dental procedures as a bonding primer with light cured resin filling material to enhance the adhesion of resin filling material to the tooth and for sealing of exposed cervical dentin and root surfaces.

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Concurrence of CDRH, Office of Device evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | ✓ |
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OR

Over-The-Counter Use

Susan Rupper

(Division Sian-Off Division of Dental, Infection Contro and General Hosp 510(k) Number

(Optional Format 1/2/96)