(146 days)
The 2 bond 2 system is used for the seating of non-metal, laboratory fabricated restorations such as: Artglass, porcelain, ceramic and composite inlays, onlays, veneers, crowns, and bridges.
2 bond 2 is used for the seating of metal-supported, laboratory fabricated restorations such as: crowns, bridges, inlays/onlays Maryland bridges, brackets and splints.
Not Found
This document is a 510(k) clearance letter from the FDA for a dental bonding system called "2 bond 2." It does not contain any information about acceptance criteria, device performance studies, or clinical trial details. The letter is an administrative document indicating that the device has been cleared for market based on substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information based on the provided text. To answer your questions, I would need a technical document, a clinical study report, or a summary of safety and effectiveness for the "2 bond 2" device, which typically accompanies a 510(k) submission but is not included in this clearance letter.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three lines extending from its head, representing the department's mission to protect the health of all Americans and provide essential human services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
OCT - 2 1997
Ms. Sharon Parker Requlatory Affairs Manager Heraeus Kulzer, Incorporated 10005 Muirlands Boulevard Irvine, California 92718-2595
Re : K971733 Trade Name: 2 Bond 2 Requlatory Class: II Product Code: KLE Dated: August 5, 1997 Received: August 7, 1997
Dear Ms. Parker:
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 reguirements 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 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 regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does
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not affect any 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 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 diagnostic 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 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 (800) 638-2041 or (301) 443-6597 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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INDICATIONS FOR USE
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510(k) Number: __ K97/733
2 bond 2 Device Name:
The 2 bond 2 system is used for the seating of non-metal, laboratory fabricated restorations such as: Artglass, porcelain, ceramic and composite inlays, onlays, veneers, crowns, and bridges.
2 bond 2 is used for the seating of metal-supported, laboratory fabricated restorations such as: crowns, bridges, inlays/onlays Maryland bridges, brackets and splints.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.
CONCURRENCE OF CHRD, OFFICE OF DEVICE EVALUATION (OED)
Susan Runner
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510/k) Number _
Prescription Use _ 14 (Per 21 CFR 801.109
OR
No Over-The Counter Use_
§ 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.