RESIN TOOTH BONDING AGENT

• K Number: K994302
• Device Name: RESIN TOOTH BONDING AGENT
• Manufacturer: PARKELL, INC.
• Date Cleared: 2000-02-07 ( 48 days)
• Product Code: KLE
• Regulation Number: 872.3200
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended 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.

Device Description

"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.

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, a study, sample sizes, data provenance, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, or training set details. The document is a 510(k) summary and an FDA clearance letter for a dental bonding agent, primarily focusing on its intended use, classification, and substantial equivalence to previously marketed devices. It does not contain the kind of technical study details you are requesting.

Summary

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FEB 7 2000

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994302

510(k) SUMMARY

Submitter:	Parkell, Inc.155 Schmitt Blvd.Box 376Farmingdale, NY 11735TEL: [phone]FAX: [phone]
Contact:	Nelson J. Gendusa, DDSDirector of ResearchParkell155 Schmitt Blvd.Box 376Farmingdale, 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, lightcured, dentin-bonding system especially formulated for use withresin composite restorative materials. The material is self-etchingand does not require acid etching of tooth surfaces. It will alsoreliably bond to properly prepared porcelain or alloy surfaces thatare free of contamination.

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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 a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The bird is positioned within a circular border, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. The text is in all capital letters and is evenly spaced around the curve.

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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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

Regulation Number and Section

§ 872.3200 Resin tooth bonding agent.

(a)
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.(b)
Classification. Class II.