(382 days)
the bonding Adhesive to be used as an orthodontic bonding agent, for the bonding of orthodontic braces on the tooth (brackets, tubes and which ever) for a limited period of time.
Not Found
This is a 510(k) clearance letter for a device called "Smart-Bond," an orthodontic bonding agent. The provided text is a regulatory document and does not contain information about acceptance criteria, device performance studies, or technical details about the device's efficacy or safety. Therefore, I cannot generate the requested table and study details.
The document only states that the device is substantially equivalent to a legally marketed predicate device, allowing it to proceed to market. It does not include performance data or clinical trial results.
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Image /page/0/Picture/1 description: The image is the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
5 1999 APR
Mr. Mark Manni Manager of Quality Assurance and Regulatory affairs G.A.C. International, Incorporated 185 Oval Drive Central Islip, New York 11722
Re : K981036 Trade Name: Smart-Bond Regulatory Class: II Product Code: DYH Dated: December 18, 1998 Received: January 6, 1999
Dear Mr. Manni
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 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (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 requlatory 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 obligation you might have under sections 531 through 542 of
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Page 2 - Mr. Manni
the Act for devices under the Electronic Product Radiation the Act for devices ander on rederal laws or regulations.
This letter will allow you to begin marketing your device as Info recei will as one ket notification. The FDA described in your sia... puivalence of your device to a legally marketed predicate device results in a classification for your marketed predicate actros 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 regaratic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on Compirated at (301) 337 ising of your device, please contact che Dffice of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to the regulation entification" (21 CFR 807.97). Other general prematice nocirrour responsibilities under the Act may be Information of Jourision of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at at Its coll-free namber (000)- 300 ===========================================================================================================================================
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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Smart-Bond Device Name:_
Indications For Use:
the bonding Adhesive to be used as an orthalontic bonding agent, for Adhesive to be used as an othershill bonding agently by a programs.
of orthodontic braces on the tooth (brackets, tubes and which addere of) for a limited period of time.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) Over-The-Count. Use OR Prescription Use (Per 21 CFR 801.109) (O. .......................................................................................................................................................................... suser (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
(10 mm)
8.4
§ 872.3750 Bracket adhesive resin and tooth conditioner.
(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.