Bond-1 C&B is used for adhesion to dentin and bonding various polymeric filling materials (composites). Also, Bond 1C&B is used for bonding of composite to metal, including (composited) i semi precious and non precious alloys, porcelain and glass and luting of same to Dentin and Enamel. Bond 1 C&B was approved by the FDA on March 21, 2000 under 510(k) # K994359.

We are adding a component called Bond-1 Self Cure Activator to be used in conjunction with Bond 1 C&B. The formula for Bond-1 Self Cure Activator is attached in the application. Bond-1 Self Cure Activator, when mixed with Bond-1 C&B will allow Bond-1 C&B to cure with or without the use of light.

Device Description

AI/ML Overview

This document describes a 510(k) submission for a dental bonding agent, Bond-1 C&B, with the addition of a "Bond-1 Self Cure Activator." It is a regulatory submission for a Class II medical device (Resin Tooth Bonding Agent) seeking clearance based on substantial equivalence to a previously approved device.

Crucially, this is not a study that proves a device meets acceptance criteria in the way a diagnostic AI device or a complex medical device with performance metrics would. This submission is for a dental adhesive and its self-cure activator. The "acceptance criteria" here are related to chemical composition, material properties, and functionality, primarily demonstrating that the new component (self-cure activator) does not negatively impact the established performance of the existing Bond-1 C&B and provides the intended self-curing capability.

Therefore, many of the requested categories (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, training sets for AI) are not applicable to this type of device submission.

Here's how to address the request based on the provided document:

Acceptance Criteria and Device Performance Study for Bond-1 C&B with Self-Cure Activator

This 510(k) submission (K013543) details the addition of a "Bond-1 Self Cure Activator" to an existing FDA-approved dental bonding agent, Bond-1 C&B (K994359). The "study" referenced in the document is the justification for substantial equivalence, focusing on the functionality of the new activator. The acceptance criteria relate to the intended function of the self-cure activator, which is to allow Bond-1 C&B to cure with or without light.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred from function)	Reported Device Performance (Inferred from submission)
Curing Mechanism	Device (Bond-1 C&B + Self-Cure Activator) must cure in the absence of light.	Bond-1 Self Cure Activator, when mixed with Bond-1 C&B, "will allow Bond-1 C&B to cure with or without the use of light." (This is the primary claim and de facto performance goal).
Compatibility	The addition of the activator should not compromise the established performance characteristics (e.g., adhesion, bond strength) of the original Bond-1 C&B.	Implied by the substantial equivalence claim. The submission adds a component to be "used in conjunction with" the existing product, suggesting compatibility. No specific performance data for adhesion or bond strength with the activator is provided in these snippets, but would typically be part of a full submission to demonstrate non-inferiority or equivalence.
Safety	The new component and combined product must be safe for intended dental use.	Implied by FDA clearance. Safety data (e.g., biocompatibility testing) would have been submitted to FDA, but is not detailed in these provided excerpts.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified in the provided documents. For a chemical additive, testing would likely involve a series of material property tests (e.g., bond strength, curing time, cytotoxicity) on a certain number of samples, not a "test set" in the sense of patient data.
Data Provenance: Not specified. For a dental material, this would typically be laboratory test data generated by the manufacturer.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not Applicable. For a dental bonding agent and its activator, "ground truth" is established through standardized material testing methods (e.g., ISO or ADA standards for bond strength, curing characteristics) conducted in a laboratory, rather than expert interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of subjective data (e.g., medical images). Material property testing results are objective and do not require expert adjudication in this manner.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not Applicable. This is a dental bonding agent, not a diagnostic imaging device or an AI system that assists human readers. MRMC studies are for evaluating the impact of AI on human reader performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not Applicable. This device is a chemical product, not an algorithm or AI system.

7. Type of Ground Truth Used

Material Property Testing Results: The "ground truth" for this device would be objective measurements from standardized laboratory tests, demonstrating the efficacy of the self-cure mechanism (e.g., successful polymerization in the absence of light) and maintaining the established properties of Bond-1 C&B. This would typically include chemical characterization, mechanical property testing (e.g., shear bond strength, flexural strength), and biocompatibility assays. The document states "The formula for Bond-1 Self Cure Activator is attached in the application," implying that the chemical composition itself is a key part of the ground truth and justification.

8. Sample Size for the Training Set

Not Applicable. This is a chemical product, not an AI/machine learning model that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not Applicable. As there is no training set, this does not apply.

Summary

{0}------------------------------------------------

510(K) SUMMARY 21.0

FEB 2 2 2002

KO13543

Bond-1 C&B is used for adhesion to dentin and bonding various polymeric filling materials (composites). Also, Bond 1C&B is used for bonding of composite to metal, including (composited). I noo, 2011-01-2015 and non precious alloys, porcelain and glass and luting of same to Dentin and Enamel. Bond 1 C&B was approved by the FDA on March 21, 2000 under 510(k) # K994359.

We are adding a component called Bond-1 Self Cure Activator to be used in conjunction with To are adding a componia for Bond-1 Self Cure Activator is attached in the application. Bond-1 Self Cure Activator, when mixed with Bond-1 C&B will allow Bond-1 C&B to cure with or without the use of light.

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

{1}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/12 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 eagle-like symbol with three curved lines representing wings or feathers.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 2 2002

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

Re: K013543

Trade/Device Name: Bond-1 C & D Regulation Number: 872.3200 Regulation Name: Resin Tooth Bonding Agent 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.

{2}------------------------------------------------

Page 2 - Ms. Tenero

You must comply with all the Act's requirements, including, but not limited to: registration 1 od inust compry wart 807); labeling (21 CFR Part 801); good manufacturing practice alle listing (21 OF Reviews the quality systems (QS) regulation (21 CFR Part 820); and if requirements to be relia 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 11ms letter will and wife of you to begine in 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 A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

5.0 INDICATION FOR USE STATEMENT

510(k) NUMBER (IF KNOWN): K013543

Bond 1 C&B DEVICE NAME:

INDICATION FOR USE:

Susan Runoy

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

(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 1 C&B K013543

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.