BOND-3 ADHESIVE

K020499 · Jeneric/Pentron, Inc. · KLE · Apr 22, 2002 · Dental

Device Facts

• Record ID: K020499
• Device Name: BOND-3 ADHESIVE
• Applicant: Jeneric/Pentron, Inc.
• Product Code: KLE · Dental
• Decision Date: Apr 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

Bond-3 Adhesive is used for the adhesion of tooth (dentin and enamel) to various polymeric filling materials (composites) and used with other conditioners or combination of conditioners for bonding composite to metal including amalgam, gold, semi precious, and non precious alloys, porcelain and glass and luting of same to Dentin and Enamel.

Device Story

Bond-3 Adhesive is a dental bonding agent used by clinicians to facilitate adhesion between tooth structure (dentin/enamel) and restorative materials (composites, metals, porcelain, glass). The device functions as an adhesive system, applied during restorative dental procedures to ensure the retention of filling materials or luting of restorations. It incorporates Methacryl-POSS to provide material improvements over the predicate. The clinician applies the adhesive to the prepared tooth surface or restoration interface to bond the restorative material. This improves the clinical success of dental restorations by ensuring durable attachment to the tooth substrate.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Resin-based dental bonding agent containing Methacryl-POSS. Classified as a resin tooth bonding agent (21 CFR 872.3200).

Indications for Use

Indicated for dental patients requiring adhesion of tooth structure (dentin and enamel) to polymeric filling materials (composites) and bonding of composites to metal (amalgam, gold, semi-precious, non-precious alloys), porcelain, and glass, including luting to dentin and enamel.

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

• Bond-1 (K936222)

Submission Summary (Full Text)

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K020499

#### 21.0 510(K) SUMMARY

Bond-3 Adhesive and Dentin Conditioning Adhesive System (Bond-1) K936222 are both used for the adhesion of tooth to various polymeric filling materials (composites) and used with other conditioners or combination of conditioners for bonding composite to metal including amalgam, gold, semi precious, and non precious alloys, porcelain and glass and luting of same to Dentin and Enamel. Bond-3 Adhesive and Dentin Conditioning Adhesive System (Bond-1) However, Bond-3 Adhesive Contains additional K936222 contain the same materials. Methacryl-POSS for added improvements. Safety and effectiveness have not been affected.

Jeneric/Pentron, Inc. 510K Submission - Bond-3 Adhesive 21.0

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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 & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with three lines representing the body or wings.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 2 2002

Ms. Annmarie Tenero Jeneric/Pentron. Incorporated 53 North Plains Industrial Road Wallingford, Connecticut 06492

Re: K020499

Trade/Device Name: Bond-3 Adhesive Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Codes: KLE and EMA Dated: February 13, 2002 Received: February 14, 2002

#### Dear Ms. Tenero:

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 (1 vir 1) it 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 - Ms. Annmarie Tenero

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 (QS) 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 and additionally 21 CFR Part 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" (21CFR Part 807.97). 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,

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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# 5.0 INDICATION FOR USE STATEMENT

# KO20499

510(k) NUMBER (IF KNOWN):

DEVICE NAME: Bond-3 Adhesive

#### INDICATION FOR USE:

Bond-3 Adhesive is used for the adhesion of tooth (dentin and enamel) to various polymeric filling materials (composites) and used with other conditioners or combination of conditioners for bonding composite to metal including amalgam, gold, semi precious, and non precious alloys, porcelain and glass and luting of same to Dentin and Enamel.

Susan Runnes

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices Silo(k) Number - Kospital Dag

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

OR

Over --The-Counter-Use (Optional Format 1-2-96)

5.0

Jeneric/Pentron, Inc. 510K Submission - Bond-3 Adhesive