(111 days)
For use in dental procedures as a resin filling material
The product is a tooth shade resin material for use in dental restorations. It consists of the company's Tokuyama's Mac Bond II bonding agent and Palfique Estelite Paste.
Mac Bond II 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.
After curing, restoration is completed with Palfique Estelite Paste or other composite resin brands.
The provided text is a 510(k) summary for the Tokuso Mac Bond II and Palfique Estelite, and the FDA's response regarding its substantial equivalence. This type of document, particularly from 1998, focuses on demonstrating equivalence to predicate devices based on material composition and intended use, rather than rigorous performance studies with detailed acceptance criteria as one might find for a more complex medical device in a modern submission.
Therefore, the requested information regarding acceptance criteria, specific study details (sample sizes, expert adjudication, MRMC, standalone performance), and ground truth establishment is largely not present in the provided text. The document primarily attests to the device's composition and intended use being similar to existing, legally marketed devices.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in the document. For a 510(k) of this nature in 1998, the primary "acceptance criterion" was demonstrating substantial equivalence to predicate devices in terms of materials, intended use, and safety, rather than specific performance metrics like accuracy or sensitivity.
- Reported Device Performance: Not detailed in terms of quantitative metrics. The document states that the product is "a tooth shade resin material for use in dental restorations" and "Mac Bond II is a tooth enamel/dentin bonding resin... to enhance the bonding of these materials to the tooth." This implies performance related to bonding and restorative function, but no specific data or metrics are provided.
2. Sample size used for the test set and the data provenance:
- Not Applicable/Not Provided. The document does not describe a "test set" in the context of evaluating performance metrics with a specific sample size. The evaluation for this 510(k) was based on comparison to predicate devices, not a clinical trial with a defined test set of patients or samples.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable/Not Provided. The concept of "ground truth" established by experts for a test set is not present in this document, as it's not a study evaluating diagnostic or prognostic accuracy.
4. Adjudication method for the test set:
- Not Applicable/Not Provided. No test set or adjudication method is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a dental material, not an AI-assisted diagnostic tool. Therefore, an MRMC study and AI assistance are not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a dental material, not an algorithm.
7. The type of ground truth used:
- Not Applicable/Not Provided. The concept of "ground truth" as typically used in performance studies (e.g., pathology, outcomes data) is not relevant for this type of device and submission. The "truth" being established here is that the device is substantially equivalent to existing, legally marketed dental materials based on its composition and stated intended use.
8. The sample size for the training set:
- Not Applicable/Not Provided. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not Applicable/Not Provided. As there is no training set.
Summary of available information from the text:
- Device Name: Tokuso Mac Bond II (bonding agent) and Palfique Estelite (composite resin paste)
- Intended Use: Tooth shade resin material for use in dental restorations; Mac Bond II enhances bonding of light-cured composite resins to enamel/dentin.
- Predicate Devices: Palfique Estelite, Scotchbond Multipurpose Adhesive, 3M Brand Restorative Z-100, Clearfil A P-X & Liner Bond II. This comparison forms the basis of the "study" for substantial equivalence.
- Safety Information: Contra-indicated for patients hypersensitive to methacrylate monomers; should not contact skin or eyes; not for OTC use.
The document represents an older style of 510(k) submission for a relatively low-risk device (dental restorative material), where the focus was heavily on chemical composition, material properties (implied by comparison to predicates), and intended use rather than detailed clinical performance studies with quantitative metrics.
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APR 2 7 1998
EXHIBIT C
510(k) Summary
Daniel J. Manelli Submitted by: Farkas & Manelli, P.L.L.C. 2000 M Street, NW (Suite 700) Washington, DC 20036 Telephone: 202-261-1000 Facsimile: 202-887-0336
On behalf of Tokuyama America, Inc. 510(k) Submission: Tokuso Mac Bond II December 30, 1997
Device Classification Name: Tooth Shade Resin Material (21 CFR §872.3690)
Predicate Devices: Palfique Estelite, Scotchbond Multipurpose Adhesive, 3M Brand Restorative Z-100, Clearfil A P-X & Liner Bond II
The product is a tooth shade resin material for use in dental restorations. It consists of the company's Tokuyama's Mac Bond II bonding agent and Palfique Estelite Paste.
Mac Bond II 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.
After curing, restoration is completed with Palfique Estelite Paste or other composite resin brands.
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 seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three intertwined human profiles. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is black and white.
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 : K980054 Trade Name: Palfique Estelite Regulatory Class: 「II Product Code: EBF Dated: April 15, 1998 Received: April 17, 1998
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. ਨੇ substantially equivalent determination assumes compliance with --the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Druq 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 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 requlation (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) 638-204% or (301) 443-6597 or at its internet address "http://www.fda/gov/cdrh/dsmamain.html".
Sincerely yours
Timo A. 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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| Page | 1 of 1 |
|---|---|
| 510(k) Number (if known): | K980054 |
| Device Name: | Palfique Estelite |
Indications For Use:
: 1
ﻳ
For use in dental procedures as a resin filling material
(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 | K980054 |
| Prescription Use (Per 21 CFR 801.109) | ✓ | OR | Over-The-Counter Use ______ (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.