TOUCH&BOND-PLUS

K020239 · Parkell, Inc. · KLE · Mar 20, 2002 · Dental

Device Facts

• Record ID: K020239
• Device Name: TOUCH&BOND-PLUS
• Applicant: Parkell, Inc.
• Product Code: KLE · Dental
• Decision Date: Mar 20, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This material is indicated for the following: 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 and cast alloy restorations that include but may not be limited to indirect composite or porcelain inlays and onlays, laminate veneers, either resin or porcelain, porcelain-fused-to-metal crowns, etc. 3. Treatment of hypersensitive areas of exposed root surfaces. 4. A cavity sealant and desensitizer applied to exposed dentin that has been prepared to receive a laboratory fabricated restoration such as porcelain-fused-to-metal crowns, cast alloy or tooth-colored inlays or onlays, veneers, etc.

Device Story

Touch&Bond-Plus is a single-bottle, self-etching, self-priming, light-cured resin tooth bonding agent containing 4-META. Device eliminates need for separate acid etching of tooth surfaces. Applied by dental professionals in clinical settings to tooth structures; polymerized using standard light-cure devices. Functions as adhesive for direct/indirect restorations and as sealant/desensitizer for hypersensitive dentin. Benefits include simplified clinical application and reduction of post-operative sensitivity.

Clinical Evidence

No clinical data provided; substantial equivalence supported by bench testing.

Technological Characteristics

Single-bottle, self-etching, self-priming, light-cured resin bonding system. Contains 4-META monomer. Compatible with standard dental light-cure devices. No specific ASTM standards or software components described.

Indications for Use

Indicated for patients requiring dental restorations or treatment of hypersensitive exposed root surfaces. Used as a bonding agent for direct filling materials (composite resins, resin-modified glass ionomers, compomers) and indirect restorations (inlays, onlays, veneers, crowns). Also used as a cavity sealant and desensitizer for prepared dentin.

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
• Optibond Solo Plus
• Optibond Solo Plus 2
• Clearfil SE Bond
• Touch&Bond

Submission Summary (Full Text)

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K020239

MAR 2 0 2002

## 510(k) SUMMARY

Parkeil, Inc. Submitter: 155 Schmitt Blvd. Box 376 Farmingdale, NY 11735 TEL: [phone] FAX: [phone] Nalson J. Gendusa, DDS Contact: Director of Research Parkell 155 Schmitt Blvd. Box 376 Farmingdale, NY 11735 15 January 2002 Submission Date: Touch&Bond-Plus Trade Name; Dentin Bonding System Common Name; Resin Tooth Bonding Agent Classification Name: Gluma One Bond, Optibond Solo Plus, Optibond Solo Equivalence: Plus 2, Clearfil SE Bond, Touch&Bond. Single bottle, self-etching, self-priming, light-cured bond-Description/Intended Use;

ing system that contains 4-META. Does not require acid etching of tooth surfaces, and can be polymerized with any available light-cure device. For use as the adhesive agent for direct or indirect restorations, and can be used as a sealant/desensitizer to minimize post-operative sensitivity,

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling three stylized birds in flight, arranged in a stacked formation.

## Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAR 2 0 2002

Dr. Nelson J. Gendusa Director of Research Parkell, Incorporation 155 Schmitt Boulevard Farmingdale, New York 11735

Re: K020239

Trade/Device Name: Touch&Bond-Plus Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE Dated: January 18, 2002 Received: January 23, 2002

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.

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.

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Page 2 - Dr. Gendusa

You must comply with all the Act's requirements, including, but not limited to: registration You must comply with an the Pice b roqu21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 607), laceling (21 CFR Pat 820) 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 I his letter will anow you to ocgin manoling of substantial equivalence of your device to 310(K) premiation notheation: "The 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 IT you desire specific ac not 10: your your vitro diagnostic devices), please contact the and additionally 21 CLR Part 609110 103. Additionally, for questions on the promotion and Office of Colliphance at (301) 89 contact the Office of Compliance at [phone]. advertising or Jour ar a regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under nothication (ZTCI K Furt 007.97). Sales got Small Manufacturers, International and the Act may be obtained them and Boumber [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Patron Cuscattiffor

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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Page ____ of _l

| 510(k) Number (if known): | K020239 |
|---------------------------|-----------------|
| Device Name: | TOUCH&BOND-PLUS |

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

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 and cast alloy restorations that include but may not be limited to indirect composite or porcelain inlays and onlays, laminate veneers, either resin or porcelain, porcelain-fused-to-metal crowns, etc.
3. Treatment of hypersensitive areas of exposed root surfaces.
4. A cavity sealant and desensitizer applied to exposed dentin that has been prepared to receive a laboratory fabricated restoration such as porcelain-fused-to-metal crowns, cast alloy or tooth-colored inlays or onlays, veneers, etc.

Susan Renner

(Division Sign-Off) piration of Dental, Infection Control,
Division of Dental, Infection Control,
and General Hosspital Devices
510(k) Number ___________________________________________________