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 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.

AI/ML Overview

This document describes a 510(k) premarket notification for the "Nano-Bond II Adhesive System". This submission is for a dental adhesive, not an AI/ML powered device. As such, the information you've requested regarding AI/ML device performance criteria, studies, and data provenance is not applicable to this 510(k) submission.

The document focuses on demonstrating substantial equivalence to a predicate device ("Nano Bond (Bond-3 Adhesive) (K020499)") based on intended use and design principles. It does not contain sections on acceptance criteria in the context of diagnostic performance metrics, details of clinical study design with human readers, ground truth establishment, or sample sizes for training/test sets as would be relevant for an AI/ML medical device.

Therefore, I cannot extract the requested information because it is not present in the provided text, which pertains to a traditional dental adhesive system.

Summary

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K071500

510(k) Summary

Nano-Bond II Adhesive System

AUG 1 0 2007

ADMINISTRATIVE INFORMATION

Manufacturer Name:	Pentron Clinical Technologies, LLC53 North Plains Industrial RoadWallingford, CT 06492Telephone 1 (203) 303-2280Fax 1 (203) 284-4986
Official Contact:	Greg Moreau
Representative/Consultant:	Floyd G. LarsonPaxMed International, LLC11234 El Camino Real, Suite 200San Diego, CA 92130Telephone 1 (858) 792-1235Fax 1 (858) 792-1236email: flarson@paxmed.com

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

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K071500

DEVICE DESCRIPTION

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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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:

Prescription Use X (Part 21 CFR 801 Subpart D)

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Page 1 ofPage 15 of 79

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.