← Product Code [KLE](/productcode/KLE) · K973245 # TOKUSO REBASE MR. BOND (K973245) _Tokuyama America, Inc. · KLE · Oct 7, 1997 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K973245 ## Device Facts - **Applicant:** Tokuyama America, Inc. - **Product Code:** [KLE](/productcode/KLE.md) - **Decision Date:** Oct 7, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3200 - **Device Class:** Class 2 - **Review Panel:** Dental ## Indications for Use For use as a bonding primer with self curing resins to enhance the adhesion of resin to the metal components of removable dentures. ## Device Story Tokuso Rebase Mr. BOND is a dental bonding primer applied by dental professionals to enhance the adhesion of self-curing acrylic resins to metal components within removable dentures. The device is not intended for over-the-counter use. It is applied during the denture fabrication or repair process in a clinical setting. The product contains materials common in dental applications. It is contraindicated for patients with known hypersensitivity to methacrylate monomers. Proper handling is required to avoid contact with skin or eyes; in case of contact, immediate rinsing with water is advised. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics Bonding primer containing methacrylate monomers. Designed for use with self-curing acrylic resins to facilitate chemical bonding to metal denture components. Non-sterile, chemical-based dental material. ## Regulatory 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. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ K973245 OCT - 7 1997 EXHIBIT D ## 510(k) Summary Daniel J. Manelli Submitted by: Farkas & Manelli, P.L.L.C. 1233 20th Street, NW (Suite 700) Washington, DC 20036 > On behalf of Tokuyama America, Inc. 510(k) Submission: Tokuso Rebase Mr. BOND August 25, 1997 The product is a bonding primer designed for use with Tokuyama's Tokuso Rebase or other types of self-curing acrylic resins to enhance the bonding of resin to metal in dentures. It is not intended for OTC use. It contains materials that are common in dental use and pose no health hazard when used according to directions. It was approved in November 1990 for marketing in Japan by the Ministry of Health and Welfare. 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 or eyes. Should contact with the skin occur, the affected area should be washed thoroughly with soap and water. Should the product come into contact with the eyes, it should be immediately rinsed out thoroughly with water and a physician should be contacted at once. {1}------------------------------------------------ Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a human figure with outstretched arms. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856 OCT - 7 1997 Mr. Daniel J. Manelli Attorney Tokuyama America, Incorporated C/O Farkas & Manelli, P.L.L.C. 1233 20th Street, N.W. #700 Washington, DC 20036 Re: K973245 Tokuso Rebase Mr. Bond Trade Name: Regulatory Class: II Product Code: KLE Dated: August 28, 1997 Received: August 29, 1997 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 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 regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 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 {2}------------------------------------------------ Page 2 - Mr. Manelli 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 described in your 510(k) premarket notification. The FDA findinq 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) 594-4618. 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 regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fqa.gov/cdrh/dsmamain.html". Sincerely yours, Timothy A. Ulatowski Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health . Enclosure {3}------------------------------------------------ Exhibit C Page 1 of of l | 510(k) Number (if known): | K973245 | |---------------------------|------------------------| | Device Name: | Tokuso Rebase Mr. BOND | Indications For Use: For use as a bonding primer with self curing resins to enhance the adhesion of resin to the metal components of removable dentures. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) unter (Division Sign-Off) Control, Division of Dental, Into and General Hospita 510(k) Number Prescription Use OR (Per 21 CFR 801.109) OF Over-The-Counter Use .. (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/device/K973245](https://fda.innolitics.com/device/K973245) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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