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 Description

Bond-3 Adhesive and Dentin Conditioning Adhesive System (Bond-1) K936222 contain the same materials. However, Bond-3 Adhesive Contains additional Methacryl-POSS for added improvements. Safety and effectiveness have not been affected.

AI/ML Overview

This document is a 510(k) submission for a dental adhesive (Bond-3 Adhesive). It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and results.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in the provided text. The submission explicitly states that "Safety and effectiveness have not been affected" by the addition of Methacryl-POSS, implying that the performance is considered similar to the predicate device (Bond-1 Adhesive K936222) which shares the same materials.

Here's a breakdown of what can and cannot be extracted from the given text:

1. A table of acceptance criteria and the reported device performance:

Not available. The document states that Bond-3 Adhesive contains additional Methacryl-POSS for "added improvements" and then asserts "Safety and effectiveness have not been affected." This is a claim of equivalence, not a presentation of specific acceptance criteria or performance data for Bond-3 itself. For a dental adhesive, acceptance criteria would typically involve bond strength (e.g., shear or tensile bond strength) to dentin, enamel, and various restorative materials, as well as biocompatibility, shelf life, and handling properties. None of these are detailed here.

2. Sample size used for the test set and the data provenance:

Not available. No specific test set or study data is presented to evaluate the performance of Bond-3 Adhesive against acceptance criteria. The submission relies on the substantial equivalence to a predicate device (Bond-1 Adhesive K936222) which is stated to contain the same materials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not available. Since no specific performance study is detailed, there's no mention of a test set requiring expert ground truth establishment.

4. Adjudication method for the test set:

Not applicable/Not available. As above, no performance study or test set is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a dental adhesive, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable/Not available. No specific performance study is detailed where ground truth would be established. The regulatory decision is based on substantial equivalence.

8. The sample size for the training set:

Not applicable/Not available. This is a physical dental adhesive, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established:

Not applicable/Not available. As above, no training set exists for this device.

Summary based on the provided text:

The provided document is a 510(k) summary for a dental adhesive. It aims to demonstrate substantial equivalence to a previously cleared predicate device (Bond-1 Adhesive K936222). The key assertion is that the addition of Methacryl-POSS to Bond-3 Adhesive does not adversely affect safety and effectiveness, implying its performance is comparable to the predicate. There are no detailed performance studies, acceptance criteria, or specific test results presented in this submission. The FDA's letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to market under general controls.

Summary

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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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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:

Susan Runnes

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

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

5.0

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

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.