(65 days)
Sebond Pink: Paste opaquer with integrated metal-resin bonding system, for framework retention (no additional bonder necessary)
Sebond Smart: Odorless metal primer, universally suitable for all metals, guarantees a lasting bond.
Sebond Grip: Increases the bond (in combination with a metal primer, e. g. Sebond Smart) between metal and opaquer, for more safety and less spalling.
Not Found
The provided text is a 510(k) summary from the FDA for a dental bonding agent. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The document only states that the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot provide the requested information.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the HHS logo, which is a stylized depiction of a human figure embracing the world. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the logo.
Public Health Service
JUN 2 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Michael Wierz Export Sales Manager Schütz-Dental GmbH Dieselstr. 5-6 61191 Rosbach GERMANY
Re: K051050
Trade/Device Name: Sebond Pink Light 5G, Sebond Pink Dark 5G, Sebond Smart 5ML, Sebond Grip 3G Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: April 20, 2005 Received: April 25, 2005
Dear Mr. Wierz:
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 - Mr. Wierz
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 Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Seritte Y. Michieu M.D.
Chiu Lin, Ph.D. 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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| Indications for Use | |
|---|---|
| 510(k) Number (if known): | K051050 |
| Device Name: | |
| Indications for Use: | |
| Sebond Pink | Paste opaquer with integrated metal-resin bonding system, for framework retention (no additional bonder necessary) |
| Sebond Smart. | Odorless metal primer, universally suitable for all metals, guarantees a lasting bond. |
| Sebond Grip | Increases the bond (in combination with a metal primer, e. g. Sebond Smart) between metal and opaquer, for more safety and less spalling. |
| 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 Purser
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(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number._
Number KOSb3
§ 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.