PALFIQUE ESTELITE

K980054 · Tokuyama America, Inc. · EBF · Apr 27, 1998 · Dental

Device Facts

• Record ID: K980054
• Device Name: PALFIQUE ESTELITE
• Applicant: Tokuyama America, Inc.
• Product Code: EBF · Dental
• Decision Date: Apr 27, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

For use in dental procedures as a resin filling material

Device Story

Tokuso Mac Bond II and Palfique Estelite Paste comprise a tooth shade resin system for dental restorations. System includes a bonding agent (Mac Bond II) and a light-cured composite resin (Palfique Estelite). Clinician applies primer to cavity preparation, allows to dry, applies bonding agent, air dries, and cures with standard visible light curing devices. Restoration is completed with composite paste. Used in clinical dental settings by licensed professionals. System enhances bonding of composite resins to tooth enamel and dentin. Benefits include effective restoration of tooth structure in anterior and posterior applications.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Tooth shade resin material consisting of methacrylate monomer-based bonding agent and light-cured composite paste. Operates via visible light curing. Intended for professional dental use. Materials are standard dental resins.

Indications for Use

Indicated for use in dental procedures as a resin filling material for anterior and posterior restorations. Contraindicated for patients with hypersensitivity to methacrylate monomers.

Regulatory Classification

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.

Predicate Devices

• Palfique Estelite
• Scotchbond Multipurpose Adhesive
• 3M Brand Restorative Z-100
• Clearfil A P-X
• Liner Bond II

Submission Summary (Full Text)

{0}------------------------------------------------

## APR 2 7 1998

K980054

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: [phone] 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.

{1}------------------------------------------------

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

{2}------------------------------------------------

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] 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

{3}------------------------------------------------

| 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) |
|---------------------------------------|---|----|------------------------------------------------------|
|---------------------------------------|---|----|------------------------------------------------------|