(29 days)
G-BOND PLUS is one-bottle typed light-cured bonding agent, and intended to be used for bonding light-cured composite resin to tooth.
Not Found
The provided document is an FDA 510(k) clearance letter for a dental bonding agent named "G-BOND PLUS." This document focuses on the regulatory authorization for marketing the device based on its substantial equivalence to a predicate device. It does not contain information regarding acceptance criteria for a specific performance study, the device's reported performance against such criteria, or details of a study that would demonstrate such performance (e.g., sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies with AI).
Therefore, I cannot answer your request based on the provided text. This document is a regulatory approval notice, not a scientific study report.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 1 2008
Mark Heiss, DDS Director, Regulatory Affairs GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803
Re: K082768
Trade/Device Name: G-BOND PLUS Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: September 17, 2008 Received: September 23, 2008
Dear Dr. Heiss:
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 - Dr. Heiss
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
J.H.amuels Endm. for 11
Chiu S. Lin, Ph. D Division 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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Section 5
Indications for Use
K0927108 510{k) Number (if known): _
Device Name: G-BOND PLUS
Indications for Use:
G-BOND PLUS is one-bottle typed light-cured bonding agent, and intended to be used for bonding light-cured composite resin to tooth.
Prescription Use (Part 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Luane
(Division Sign-Off) Division of Sign-Olf)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K052768
Page 5.1 of 5.1
§ 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.