TOKUYAMA M-BOND

{0}------------------------------------------------ Exhibit D 510(k) Summary K011854 Submitted by: - Daniel J. Manelli Manelli Denison & Selter, P.L.L.C. 2000 M Street, NW (Suite 700) Washington, DC 20036 Telephone: 202-261-1000 On behalf of Tokuyama America, Inc. 510(k) Submission: Tokuyama M Bond August 10, 2001 The product is a self cured adhesive resin cement. It is intended for use in adhesion and fixation between tooth and prosthesis, tooth and tooth, and between two or more prostheses. Clinical applications include the cementation of inlays, onlays, crowns, metal posts and cores and similar applications. The product is for use only by dental practitioners; it is not intended for OTC use. It contains materials that pose no health hazard when used according to directions and has received the approval of the Japanese Government. It is substantially equivalent to various marketed dental cement products, including the following: | Bistite II SC (Tokuyama) | K991711 | |--------------------------|---------| | C&B Metabond (Parkhill) | K960464 | | Panavia 21 (Kurarey) | K933030 | The use of the product is contra-indicated for patients who are hypersensitive to methacrylate monomers. It should not be allowed to come into contact with skin, mucosal membrane, eyes or clothing. Should contact with the eyes occur, the eyes should be thoroughly flushed with water followed by immediate contact with a physician. {1}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three swooping lines forming its body and wings. The eagle faces to the right. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 SEP - 4 2001 Tokuyama America, Incorporated C/O Mr. Daniel J. Manelli Attorney Manelli, Dension & Selter, P.L.L.C 2000 M Street Northwest, Suite 700 Washington, DC 20036 Re : K011854 Tokuvama M-Bond Trade/Device Name: Requlation Number: 872.3275 II Regulatory Class: Product Code: EMA Dated: June 13, 2001 Received: June 13, 2001 Dear Mr. Manelli: 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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸੈ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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. {2}------------------------------------------------ Page 2 - Mr. Manelli concerning your device in the Federal Register. Please note: this response to your premarket notification submission does ent affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic emroduct Radiation Control provisions, or other Federal laws or regulations. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA asbeing 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html. Sincerely yours, Victor Timothy A. Ulatowski Timot Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Exhibit C 510(k) Number (if known): K011854 Tokuyama M - Bond Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications For Use: For use as a dental cement for adhesion and fixation between tooth and r or ass a a actiture of noth, and between two or more prostheses. (Please Do Not Write Below This Line - Continue On Another Page If Needed) Concurrence of CDRH, Office of Device evaluation (ODE) Susan Rumm OR (Division Sign-Off) Division of Dental, Infection Control, General Hospital Deyic Humber ....................................................................................................................................................................... Prescription Use (Per 21 CFR 801.109) \$\checkmark\$ Over-The-Counter Use