OPTIBOND SOLO PLUS 2

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for Sybron Dental Specialties, Inc. The word "SYBRON" is in large, bold, black letters at the top of the image. Below that, in smaller, bold, black letters, are the words "DENTAL SPECIALTIES, INC." K991808 # Section III - 510(k) Summary of Safety and Effectiveness ## Submitter: Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person May 1999 Date Summary Prepared: #### Device Name: - . Trade Name - OptiBond Solo Plus 2 - Common Name Bonding Agent . - Classification Name Resin Tooth Bonding Agent, per 21 CFR § 872.3200 . ### Devices for Which Substantial Equivalence is Claimed: - Kerr Corporation, OptiBond Solo Plus . #### Device Description: The device is a multi-purpose bonding agent designed to be used in direct situations including composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, amalgam sealing and bonding composite core build-up materials, and for indirect situations including veneers, onlays, inlays, crowns, and post cementation. #### Intended Use of the Device: The intended use of OptiBond Solo Plus 2 is for bonding in direct situations, i.e., composite to enamel and/or dentin, composite repair, porcelain repair, composite to metal, amalgam sealing, bonding composite core build-up materials, and for indirect situations, i.e., veneers, onlays, inlays, crowns, post cementation. #### Substantial Equivalence: OptiBond Solo Plus 2 is substantially equivalent to other legally marketed devices in the United States. The bonding agent marketed by Kerr Corporation functions in a manner similar to and is intended for the same use as the product manufactured by Kerr Dental Materials Center. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure in profile, with three curved lines representing the body and head. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUL - 9 1999 Ms. Colleen Boswell Manager, Regulatory Affairs Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867 Re : K991808 OptiBond Solo Plus 2 Trade Name: Requlatory Class: II Product Code: KLE May 26, 1999 Dated: Received: May 27, 1999 Dear Ms. Boswell: 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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. {2}------------------------------------------------ Page 2 - Ms. Boswell this response to your premarket notification Please note: Flease note: "Chip refect 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 regulations. This letter will allow you to begin marketing your device as Inib itcell will who aremarket notification. The FDA described in your leguivalence of your device to a legally Linding of bubboarded in a classification for your markeed predious and thus, pour device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of villo draghobero at (301) 594-4692. Additionally, for questions on compreaded advertising of your device, please contact the office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to the regulation cherclose, "Missimally of "Other general information on your responsibilities under the Act may be Information on your wis on of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at at its coll free namber (o://www.fdfl.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 {3}------------------------------------------------ # ારવવા Section I - Indications for Use 510(k) Number: K9911808 Device Name: OptiBond Solo Plus 2 Indications for Use: OptiBond Solo Plus 2 is a multi-purpose bonding agent designed to be used in direct situations, i.e., composite to enamel and/or dentin, composite repair, porcelain repair, , composite to metal, amalgam sealing, bonding composite core build-up materials, and indirect situations, i.e., veneers, onlays, inlays, crowns, (used in conjunction with a resin luting agent) post cementation. Susan Rumpes (Division Sign-Off) Division of Dental, Infection Control, and General Hospita 5 : O(k) Number _ **Prescription Use** **(Per 21 CFR 801.109)**