RESIN TOOTH BONDING AGENT

K994302 · Parkell, Inc. · KLE · Feb 7, 2000 · Dental

Device Facts

• Record ID: K994302
• Device Name: RESIN TOOTH BONDING AGENT
• Applicant: Parkell, Inc.
• Product Code: KLE · Dental
• Decision Date: Feb 7, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

TO BE NAMED may be described as a single-bottle, light cured, dentin-bonding system especially formulated for use with resin composite restorative materials. The material is self-etching and does not require acid etching of tooth surfaces. It will also reliably bond to properly prepared porcelain or alloy surfaces that are free of contamination.

Device Story

Single-bottle, light-cured, self-etching dentin-bonding system; eliminates need for separate acid etching. Applied by dental professionals in clinical settings to tooth surfaces, porcelain, or alloy. Functions as adhesive interface for direct composite restorations, indirect restorations (inlays, onlays, veneers, crowns), and treatment of root hypersensitivity. Provides chemical bond between tooth structure/restorative material and restoration; improves retention and marginal seal; reduces post-operative sensitivity.

Clinical Evidence

No clinical data provided. Substantial equivalence based on bench testing and comparison to legally marketed predicate devices.

Technological Characteristics

Single-bottle, light-cured, self-etching resin-based adhesive system. Formulated for bonding to dentin, enamel, porcelain, and cast alloys. Applied via brush or applicator; polymerized using standard dental curing lights.

Indications for Use

Indicated for use as a dentin bonding agent with direct filling materials (composite resins, resin-modified glass ionomers, compomers); as a bonding agent with resin cements or composite luting agents for indirect tooth-colored restorations (inlays, onlays, laminate veneers); for treatment of hypersensitive exposed root surfaces; and as a cavity sealant for prepared dentin prior to laboratory-fabricated restorations (porcelain-fused-to-metal crowns, cast alloy inlays/onlays). Prescription use only.

Regulatory Classification

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.

Predicate Devices

• Gluma One Bond
• Clearfil SE Bond
• Optibond Solo

Submission Summary (Full Text)

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FEB 7 2000

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## 994302

## 510(k) SUMMARY

| Submitter: | Parkell, Inc.<br>155 Schmitt Blvd.<br>Box 376<br>Farmingdale, NY 11735<br>TEL: [phone]<br>FAX: [phone] |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Nelson J. Gendusa, DDS<br>Director of Research<br>Parkell<br>155 Schmitt Blvd.<br>Box 376<br>Farmingdale, NY 11735 |
| Submission Date: | 14 December 1999 |
| Trade Name: | Currently Not Available |
| Common Name: | Dentin Bonding System |
| Classification Name: | Resin Tooth Bonding Agent |
| Equivalence: | Gluma One Bond, Clearfil SE Bond, Optibond Solo, et al. |
| Description/Intended Use: | "TO BE NAMED" may be described as a single-bottle, light<br>cured, dentin-bonding system especially formulated for use with<br>resin composite restorative materials. The material is self-etching<br>and does not require acid etching of tooth surfaces. It will also<br>reliably bond to properly prepared porcelain or alloy surfaces that<br>are free of contamination. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

7 2000 FEB

Mr. Nelson J Gendusa, D.D.S. Director of Research Parkell, Incorporated 155 Schmitt Boulevard Farmingdale, NY 11735

Re : K994302 PARKELL RESIN TOOTH BONDING AGENT Trade Name: Requlatory Class: II Product Code: KLE December 17, 1999 Dated: Received: December 21, 1999

Dear Dr. Gendusa:

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, Druq, 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. ನ್ನಡ 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 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

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Page 2 - Dr. Gendusa

obligation you might have under sections 531 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 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 [phone] or [phone] 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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K994307 510(k) Number (if known):

Device Name: _ "TO BE NAMED"

This material is indicated for the following: Indications for Use:

1. A dentin bonding agent used with direct filling materials that include but may not be limited to, composite

resins, resin modified glass ionomers or compomers, etc.

2. A dentin bonding agent used with resin cements or composite luting agents to retain indirect tooth-colored

restorations that include but may not be limited to indirect composite or porcelain inlays and onlays, lamin

veneers, either resin or porcelain, etc.

3. Treatment of hypersensitive areas of exposed root surfaces.

4. A cavity sealant applied to exposed dentin that has been prepared to receive a laboratory fabricated

restoration such as porcelain-fused-to-metal crowns, cast alloy inlays or onlays, etc.

- PRESCRIPTION DEVICE

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devi 510(k) Number