(111 days)
For use in dental procedures as a bonding primer with light cured resin filling material to enhance the adhesion of resin filling material to the tooth
The product is a tooth enamel/dentin bonding resin for use with Tokuyama's Tokuso Estelite or other types of light cured composite resins to enhance the bonding of these materials to the tooth. It may be used in anterior and posterior applications. After mixing and applying the primer and allowing it to dry, as directed, the bonding agent is applied to the whole cavity preparation. After air drying, the bonding agent is cured with currently marketed visible light curing devices.
This document is a 510(k) premarket notification for a dental bonding agent, Tokuso Mac Bond II. It confirms the device's substantial equivalence to previously marketed devices and permits its market entry. However, the document does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or multi-reader multi-case studies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the provided text lacks this specific data.
The document primarily focuses on:
- Device Identification: Tokuso Mac Bond II, a resin tooth bonding agent.
- Intended Use: As a bonding primer with light-cured resin filling material to enhance adhesion to the tooth in dental procedures (anterior and posterior applications).
- Predicate Devices: Tokuso Light Bond, Scotchbond Adhesive System, Clearfil Liner Bond 2.
- Regulatory Information: Classified as Class II, Product Code EBF.
- Safety Information: Contains common dental materials, contraindicated for methacrylate monomer hypersensitivity, precautions for skin/eye contact, and flammability.
To answer your specific questions, information from a different part of the 510(k) submission (e.g., performance data, bench testing results, clinical study reports) would be necessary.
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EXHIBIT C
APR 27 1998
KA980058
510(k) Summary
Submitted by:
Daniel J. Manelli Farkas & Manelli, P.L.L.C. 2000 M Street, NW (Suite 700) Washington, DC 20036 Telephone: 202-261-1000 202-887-0336 Facsimile:
On behalf of Tokuyama America, Inc. 510(k) Submission: Tokuso Mac Bond II December 30, 1997
Device Classification Name: Resin tooth bonding agent (21 CFR §872.3200)
Predicate Devices: Tokuso Light Bond, Scotchbond Adhestie System, Clearfil Liner Bond 2
The product is a tooth enamel/dentin bonding resin for use with Tokuyama's Tokuso Estelite or other types of light cured composite resins to enhance the bonding of these materials to the tooth. It may be used in anterior and posterior applications. After mixing and applying the primer and allowing it to dry, as directed, the bonding agent is applied to the whole cavity preparation. After air drying, the bonding agent is cured with currently marketed visible light curing devices.
The product 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.
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. Neither the product nor its vapors should be exposed to an open flame.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized representation of three human profiles facing to the right, with flowing lines suggesting movement or progress.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 7 1998
Tokuyama America, Incorporated C/O Mr. Daniel J. Manelli Farkas & Manelli, P.L.L.C. 2000 M. Street, NW Suite 700 Washington, DC 20036
Re : K980058 Tokuso Mac Bond II Trade Name: Regulatory Class: II Product Code: EBF Dated: April 15, 1998 April 17, 1998 Received:
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 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. ਵਿ 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 requlation 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 through 542 of
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Page 2 - Mr. Manelli
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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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.fda.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
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510(k) Number (if known): K980058
Tokuso Mac Bond II bonding agent Device Name:
Indications For Use:
(Per 21 CFR 801.109)
For use in dental procedures as a bonding primer with light cured resin filling material to enhance the adhesion i of resin filling material to the tooth
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number | K980058 | |
|---|---|---|
| -- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------- |
| Prescription Use | OR | Over-The-Counter Use |
|---|---|---|
| ------------------ | ---- | ---------------------- |
(Optic
(Optional Format 1-2-96)
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.