(63 days)
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.
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.
This document is a 510(k) summary for a dental bonding agent called "EASY BOND." It does not contain information about acceptance criteria, device performance, or a study proving that a device meets particular acceptance criteria, as it is a notice of intent to market a device and the FDA's response finding substantial equivalence.
Therefore, I cannot extract the requested information from the provided text. The document primarily focuses on regulatory classification, intended use, and the FDA's clearance for marketing based on substantial equivalence to existing devices, rather than detailed performance study results.
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510(k) SUMMARY
AUG 2 9 1997
| Submitted By: | Parkell Products Inc. |
|---|---|
| 155 Schmitt Blvd. | |
| Box 376 | |
| Farmingdale, NY 11735 | |
| TEL: 516-249-1134 | |
| FAX: 516-249-1242 | |
| 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,dentin bonding system especially formulated for use with resincomposite restorative materials. It will also create reliable bondsproperly prepared metallic surfaces that are free fromcontamination. EASY BOND is recommended on moist dentinsubstrates 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.
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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
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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 (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
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| 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)
§ 872.3200 Resin tooth bonding agent.
(a)
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.(b)
Classification. Class II.