NANO-BOND II ADHESIVE SYSTEM

K071500 · Pentron Clinical Technologies · KLE · Aug 10, 2007 · Dental

Device Facts

• Record ID: K071500
• Device Name: NANO-BOND II ADHESIVE SYSTEM
• Applicant: Pentron Clinical Technologies
• Product Code: KLE · Dental
• Decision Date: Aug 10, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended Use

Nano-Bond II Adhesive System is used for the adhesion of dentin 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

Nano-Bond II Adhesive System is a light-cured, reinforced dentin bonding agent used in dental procedures. The system consists of a self-etch primer, an adhesive, and an optional dual-cure activator. It is applied by dental professionals in a clinical setting to facilitate the adhesion of composite filling materials to dentin, enamel, and various restorative materials including metals, porcelain, and glass. By creating a bond between the tooth structure and the restorative material, the device aids in the retention and sealing of dental restorations, potentially improving clinical outcomes and restoration longevity.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Light-cured, reinforced dentin bonding agent. Components: Nano-Bond Self-Etch Primer, Nano-Bond II Adhesive, and optional Nano-Bond II Dual Cure Activator. Form factor: liquid kit/refills. Energy source: light-curing (external dental curing light).

Indications for Use

Indicated for dental patients requiring adhesion of dentin to polymeric filling materials (composites) and bonding of composites to metal (amalgam, gold, 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

• Nano Bond (Bond-3 Adhesive) (K020499)

Submission Summary (Full Text)

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# K071500

## 510(k) Summary

## Nano-Bond II Adhesive System

AUG 1 0 2007

#### ADMINISTRATIVE INFORMATION

| Manufacturer Name: | Pentron Clinical Technologies, LLC<br>53 North Plains Industrial Road<br>Wallingford, CT 06492<br>Telephone [phone]<br>Fax [phone] |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Greg Moreau |
| Representative/Consultant: | Floyd G. Larson<br>PaxMed International, LLC<br>11234 El Camino Real, Suite 200<br>San Diego, CA 92130<br>Telephone [phone]<br>Fax [phone]<br>email: [e-mail] |

#### DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name: Common Name: Classification Name: Classification Regulations : Product Codes: Classification Panel: Reviewing Branch:

Nano-Bond II Adhesive System Resin, dental cement Resin tooth bonding agent, dental cement (21 CFR 872.3200, 872.3275) Class II KLE, EMA Dental Products Dental Devices

#### ESTABLISHMENT REGISTRATION

Establishment Registration Number: 3003690896 Owner/Operator Number: 9050352

#### INTENDED USE

Nano-Bond II Adhesive System is used for the adhesion of dentin 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.

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K071500

#### DEVICE DESCRIPTION

Nano-Bond II Adhesive System is a light-cured, reinforced dentin bonding agent. It is provided in a kit containing two components, Nano-Bond Self-Etch Primer and Nano-Bond II Adhesive and an optional component, Nano-Bond II Dual Cure Activator. The components also are available individually as refills.

#### EQUIVALENCE TO MARKETED PRODUCT

Pentron Clinical Technologies, LLC submits the information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, Nano-Bond II Adhesive System is substantially equivalent in indications and design principles to the following predicate device which has been determined by FDA to be substantially equivalent to preamendment devices: Nano Bond (Bond-3 Adhesive) (K020499) from Jeneric/Pentron, Inc.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three talons. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Pentron Clinical Technologies, LLC C/O Mr. Floyd G. Larson President PaxMed International, LLC 11234 El Camino Real, Suite 200 San Diego, California 92130

AUG 1 0 2007

Re: K071500

Trade/Device Name: Nano-Bond II Adhesive System Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: II Product Code: KLE, EMA Dated: May 25, 2007 Received: May 31, 2007

Dear Mr. Larson:

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.

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Page 2 - Mr. Larson

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 (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), 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 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/industry/support/index.html.

Sincerely yours,

Ques

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known): K071500

Device Name: Nano-Bond II Adhesive System

Indications for Use:

Nano-Bond II Adhesive System is used for the adhesion of dentin 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.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|----------------------------------------------|---------|
| Division of Anesthesiology, General Hospital | |
| Infection Control, Dental Devices | |
| 510(k) Number: | K071507 |

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