COMP. E

K032179 · Parkell, Inc. · KLE · Sep 9, 2003 · Dental

Device Facts

• Record ID: K032179
• Device Name: COMP. E
• Applicant: Parkell, Inc.
• Product Code: KLE · Dental
• Decision Date: Sep 9, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

For use in repairing, adding to, or otherwise modifying the surface of resins . Especially useful for enhancing co-polymentzation between an old and a new composite resin when the former requires refreshing or repair in clinical life. May also be used as the primer of indirect, resin-based restorations to enhance the bond of these with resin-based luting materials. This agent is also useful for bond of highly cross-inked denture teeth, acrylic or composite, to denture base resins, This material will improve the union between resin surfaces in a myriad of situations, both intra- and exta-orally.

Device Story

Comp.E is a light-cured, resin-based primer; applied to surfaces of existing composite resin restorations or indirect restorations to enhance co-polymerization and bonding with new resin materials or luting agents. Used by dental professionals in clinical settings; facilitates repair or modification of resin surfaces intra-orally or extra-orally. Improves union between old and new resin surfaces; enhances clinical longevity of restorations.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Light-cured, resin-based primer. Formulated to enhance co-polymerization between resin surfaces. Applied as a liquid primer.

Indications for Use

Indicated for dental patients requiring repair, modification, or refreshing of existing composite resin restorations, bonding of indirect resin-based restorations, or bonding of denture teeth (acrylic or composite) to denture base resins.

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

• Special Bond
• Special Bond II

Submission Summary (Full Text)

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

## 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: | 15 April 2003 |
| Trade Name: | Currently Not Available |
| Common Name: | Resin Primer |
| Classification Name: | Material, Tooth Shade, Resin |
| Equivalence: | Special Bond and Special Bond II |
| Description/Intended Use: | A light-cured, resin-based primer that is used to enhance<br>the bond of old to new resin-based materials. The<br>material is indicated for use on the intaglio of indirect<br>composite restorations. It can be used to refresh the<br>worn but otherwise intact surfaces of composite resin<br>restorations. |

:

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

Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" written around it. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes. The symbol is composed of curved lines and is positioned in the center of the circle.

Public Health Service

SEP - 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nelson J. Gendusa, DDS Director of Research Parkell, Incorporated 155 Schmitt Boulevard, Box 376 Farmingdale, New York 11735

Re: K032179

Trade/Device Name: Comp.E Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Codes: KLE and EBI Dated: July 09, 2003 Received: July 14, 2003

Dear Dr. Gendusa:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

## Page 2 - Nelson J. Gendusa, DDS

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Susan Runner
Susan Runner, DDS, MA

Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Page 1 of 1

510(k) Number (if known):_

Device Name: _Comp. E

Indications for Use: For use in repairing, adding to, or otherwise modifying the surface of resins . Especially useful for enhancing co-polymentzation between an old and a new composite resin when the former requires refreshing or repair in clinical life. May also be used as the primer of indirect, resin-based restorations to enhance the bond of these with resin-based luting materials. This agent is also useful for bond of highly cross-inked denture teeth, acrylic or composite, to denture base resins, This material will improve the union between resin surfaces in a myriad of situations, both intra- and exta-orally.

Kai Mully for MSR

(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

510(k) Number: K 032179