EASY BOND

K972421 · Parkell, Inc. · KLE · Aug 29, 1997 · Dental

Device Facts

• Record ID: K972421
• Device Name: EASY BOND
• Applicant: Parkell, Inc.
• Product Code: KLE · Dental
• Decision Date: Aug 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

EASY BOND may be described as a single-bottle, light-cured, dentin bonding system especially formulated for use with resin composite restorative materials. It will also create reliable bonds properly prepared metallic surfaces that are free from contamination. EASY BOND is recommended on moist dentin substrates that have had any smear layer removed.

Device Story

EASY BOND is a single-bottle, light-cured dentin bonding system used by dental professionals in clinical settings. The device is applied to prepared dentin surfaces (with smear layer removed) or metallic surfaces. It functions as an adhesive interface between the tooth structure/metal and resin composite restorative materials. The material is polymerizable using standard visible light curing devices. By sealing dentinal tubules, it reduces patient hypersensitivity and improves the retention of dental restorations. It is intended for prescription use.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on the chemical composition and intended use being consistent with legally marketed predicate dental bonding agents.

Technological Characteristics

Single-bottle, light-cured dentin bonding system. Composition includes common dental resins (acrylates/methacrylates). Polymerization is achieved via external visible light curing devices. Form factor is a liquid bonding agent.

Indications for Use

Indicated for use as a tooth-bonding agent to seal patent dentinal tubules to reduce hypersensitivity and to aid in the retention of tooth-colored dental restorative materials applied over prepared cavities. Contraindicated in persons with known acrylate or methacrylate hypersensitivities.

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

• Prime & Bond 2.1
• Clearfil Liner Bond 2
• Optibond
• Syntac

Submission Summary (Full Text)

{0}------------------------------------------------

K972421

## 510(k) SUMMARY

## AUG 2 9 1997

| Submitted By: | Parkell Products Inc. |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 155 Schmitt Blvd. |
| | Box 376 |
| | Farmingdale, NY 11735 |
| | TEL: [phone] |
| | FAX: [phone] |
| Contact: | Nelson J. Gendusa, DDS |
| | Director of Research |
| | Parkell |
| | 155 Schmitt Blvd. |
| | Box 376 |
| | Farmingdale, NY 11735 |
| Submission Date: | 23 June 1997 |
| Trade Name: | EASY BOND |
| Common Name: | Dentin Bonding System |
| Classification Name: | Tooth Bonding Agent |
| Equivalence: | Prime & Bond 2.1, Clearfil Liner Bond 2, Optibond, Syntac |
| Description/Intended Use: | EASY BOND may be described as a single-bottle, light-cured,<br>dentin bonding system especially formulated for use with resin<br>composite restorative materials. It will also create reliable bonds<br>properly prepared metallic surfaces that are free from<br>contamination. EASY BOND is recommended on moist dentin<br>substrates that have had any smear layer removed. |

The above-cited material contains ingredients that are common in dental resins and bonding agents, and pose no health hazard when used according to directions. Use of resinous materials may be contraindicated in persons with known acrylate and/or methacrylate and/or hypersensitivities. The material herein described is polymerizable with currently available visible light curing devices.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nelson J. Gendusa, DDS Director of Research Parkell Products, Incorporated 155 Schmitt Boulevard Farmingdale, New York 11735

AUG 2 9 1007

Re : K972421 Easy Bond Trade Name: Regulatory Class: II Product Code: KLE Dated: June 23, 1997 Received: June 24, 1997

Dear Dr. Gendusa:

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 The general controls provisions of the Act of the Act. include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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 Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

{2}------------------------------------------------

Paqe 2 - Dr. Gendusa

through 542 of the Act for devices under the Electronic emough Radiation Control provisions, or other Federal laws or requlations.

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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 Office of Compriance at (30%) 33 100% - 100% - 100% per 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

Ws. Calabrese

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

Enclosure

{3}------------------------------------------------

| 510(k) Number (if known): | K972421 |
|---------------------------|---------|
|---------------------------|---------|

Device Name:

EASY BOND

1300

Indications For Use: :

For use as a tooth-bonding agent that seals patent dentinal tubules to reduce hypersensitivity and aids in the retention of tooth-colored dental to reduce hypersenstering into are over EASY BOND that has been painted onto prepared cavities.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner

(Division Sign-Of Division of Dental, and General Hospita 5,10(k) Numbar

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)