Dentin Conditioning and Adhesive System (Bond-1) is used for adhesion to Dentin of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bonding of 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

We are adding a component called Bond-1 Self Cure Activator to be used in conjunction with Dentin Conditioning and Adhesive System (Bond-1). The formula for Bond-1 Self Cure Activator is attached in the application. Bond-1 Self Cure Activator, when mixed with Dentin Conditioning and Adhesive System, allows the Bond-1 C&B to cure with or without the use of light.

AI/ML Overview

The provided text is a 510(k) summary for a dental adhesive system (Dentin Conditioning and Adhesive System (Bond-1)) seeking to add a new component, Bond-1 Self Cure Activator. This document is a regulatory filing, not a scientific study report. Therefore, it does not contain the acceptance criteria or a study demonstrating the device meets those criteria.

The information typically found in such a study would include:

Acceptance Criteria for Performance: These would define the minimum performance thresholds for the dental adhesive, such as bond strength (e.g., megapascals of shear or tensile bond strength) to dentin and other restorative materials, or microleakage scores. These criteria would likely be based on international standards (e.g., ISO standards for dental materials) or established clinical benchmarks.
Reported Device Performance: This would be the actual measured performance of the device (Bond-1 with the Self Cure Activator) in laboratory tests, compared against the acceptance criteria.
Study Design: Details about the type of study (e.g., in vitro bond strength test, microleakage study), sample sizes for the test groups (e.g., number of teeth, number of bonded specimens), and the materials used.
Data Provenance: Information on where the tests were conducted.
Ground Truth Establishment: For dental materials, "ground truth" often refers to the objective measurement of a physical property (like bond strength). This is not typically established by human experts in the same way as an imaging device. Instead, it's determined by standardized laboratory procedures and equipment (e.g., universal testing machine for bond strength).
Training Set Data: This kind of dental material study typically doesn't involve "training sets" in the machine learning sense. The performance is measured directly.

Summary based on the provided text:

This document is a 510(k) Pre-market Notification for a modification to an existing dental adhesive system. It does not present a study or acceptance criteria for the device's performance. Instead, it states that a new component (Bond-1 Self Cure Activator) is being added to an already approved device (Dentin Conditioning and Adhesive System (Bond-1), previously approved under K973388). The goal of this filing is to demonstrate substantial equivalence to the predicate device, not necessarily to re-demonstrate comprehensive performance against specific acceptance criteria in a new study.

The text does not include the following information that would be necessary to answer the prompt directly:

A table of acceptance criteria and the reported device performance.
Sample sizes used for any test set or data provenance.
Number of experts used to establish ground truth or their qualifications.
Adjudication method for a test set.
Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
Information on a standalone algorithm performance.
The type of ground truth used (beyond implying standardized material testing if a study were present).
Sample size for a training set.
How ground truth for a training set was established.

In essence, the provided document is a regulatory letter acknowledging receipt and review of a 510(k) submission, and the 510(k) summary itself is a description of the device and its intended use, rather than a detailed report of a study and its results against acceptance criteria.

Summary

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K013542

21.0 510(K) SUMMARY

Jeneric/Pentron, Inc. 510K Submission - Bond 1 C&B K013543

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three overlapping lines, possibly representing an abstract human figure or a symbol of health and well-being.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 4 2002

Ms. Annmarie Tenero Jeneric/Pentron, Incorporated 53 North Plains Industrial Road P.O. Box 724 Wallinford, Connecticut 06492-0724

Re: K013542

Trade/Device Name: Dentin Conditioning and Adhesive System (Bond-1) Regulation Number: 872.3200 Regulation Name: Dental Adhesive System Regulatory Class: II Product Code: KLE Dated: December 3, 2001 Received: December 4, 2001

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 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 - Ms. 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) 594-4613dditionally, 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 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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K013542

FEB 1 4 2002

6.0 EXECUTIVE SUMMARY

INDICATIONS FOR USE:

Dentin Conditioning and Adhesive System (Bond-1) is used for adhesion to Dentin of various Denin Conditioning and Admosive Bystens (2) vith other conditioners or combination of polyment inning matchals (composites) acce 1. colding amalgam, gold, semi precious and conditioners for vollaning of composite to no luting of same to dentin and enamel. Dentin non precious andys, porcelan and glass and hang of the FDA on September 12, 1997 under 510(k) # K973388.

We are adding a component called Bond-1 Self Cure Activator to be used in conjunction with We are additioning and Adhesive System (Bond-1). The formula for Bond-1 Self Cure Activator is attached in the application.

MODIFIED OR ENHANCED VERSION OF PREDICATE DEVICE:

MODIFIED OK ENIANCED TEXDICAL Cure Activator to be used in conjunction with we are adding a component cance Bone 7 Deli Carmula for Bond-1 Self Curre Activator is Dentin Conditioning and Adnesve Bystem. "The Activator, when mixed with Dentin Conditioning
attached in the application. Bond-1 Self Cure Activate the was of light allached in the application. "Dond T Bon Carol of C&B to cure with or without the use of light.

IDENTIFY ALL ACCESSORIES:

Robert wms for Dr. Susan Rummer

Division Sign-Off) വിഴിടിഠന ടിട്ടുന-ഠനം
Division of Dental, Infection Control, and General Hospital Devices 42 ් (උද්) Number -

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.