Kerr Nexus One Bottle Adhesive is indicated for all applications where a simple, dependable adhesive is required to bond etched natural tooth structure to composite restorative materials, porcelain, and both precious and non-precious metals.

Device Description

Kerr Nexus One Bottle Adhesive is an all purpose dental adhesive consisting of a visible light curable methacrylate resin based mixture of monomers capable of forming both chemical and mechanical adhesive bonds to natural tooth structures ( enamel and dentin ) and to commonly used restorative materials ( composite resin, porcelain and metals ). It is supplied as a one bottle, single step dental adhesive that is simple to use and produces fast, strong adhesion suitable for all commonly used restorative techniques. The organic solvent component allows the application of the adhesive to flow into micro-fissures of the substrate smoothly and when the fast evaporating solvent is removed a thin resin layer remains to form a tight bonding interface between tooth and restorative materials.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Kerr Nexus One Bottle Adhesive (a dental adhesive)

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safety
Cytotoxicity (MEM Elution Method USP23)	Passed (Independent Laboratory Evaluation by Toxicon Corporation)
Mutagenicity (Salmonella Typhimurium REVERSE MUTATION ASSAY (Ames Test))	Passed (Independent Laboratory Evaluation by Toxicon Corporation)
Efficacy / Substantial Equivalence
Bonds etched natural tooth structure to composite restorative materials, porcelain, and both precious and non-precious metals effectively.	"Performs as well or better than PRIME & BOND 2.1 and ONE-STEP" (predicate devices).
Provides fast, strong adhesion suitable for all commonly used restorative techniques.	"Produces fast, strong adhesion suitable for all commonly used restorative techniques."
Simple to use (one bottle, single step).	"Simple to use and produces fast, strong adhesion... One bottle, single-step dental adhesive."
Forms chemical and mechanical adhesive bonds.	"Capable of forming both chemical and mechanical adhesive bonds to natural tooth structures... and to commonly used restorative materials."

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

Test Set Sample Size: Not explicitly stated for specific efficacy or safety tests within the document. The efficacy is based on "in-house testing and side by side test comparisons." The biocompatibility tests are referred to as "various types of biocompatibility tests," implying multiple tests, but the quantity of samples per test is not mentioned.
Data Provenance: Not explicitly stated. The document refers to "in-house testing" and tests by an "independent laboratory" (Toxicon Corporation). It's most likely prospective testing conducted specifically for this submission, rather than retrospective analysis of existing data.

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

Number of Experts: Not applicable or not stated for the technical bench testing.
Qualifications of Experts: N/A. The evaluation was based on laboratory testing for biocompatibility and bench testing for efficacy against predicate devices. Ground truth here refers to measurable outcomes from these tests.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The efficacy and safety are determined by objective laboratory tests and comparative bench testing, not by expert consensus on subjective interpretations.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

MRMC Study: No. This device is a dental adhesive, and its performance is evaluated through physical and chemical bench testing, not through a diagnostic interpretation or a human-in-the-loop scenario that would require an MRMC study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Standalone Performance: Not applicable in the context of AI. The "standalone" performance here would refer to the intrinsic adhesive properties and biocompatibility of the material itself, which were indeed tested without human interpretation as part of a diagnostic process.

7. The Type of Ground Truth Used

Type of Ground Truth:
- Safety: Laboratory test results based on established international standards (ISO 10993 for biocompatibility) and specific assays (MEM Elution, Ames Test). The ground truth is the chemical and biological response observed in these standardized tests.
- Efficacy: Bench test results comparing the adhesive properties (e.g., bond strength, flow characteristics) of the Kerr Nexus One Bottle Adhesive against two legally marketed predicate devices (Prime & Bond 2.1 and One-Step). The ground truth is the measurable performance of the adhesive in these controlled laboratory settings, demonstrating "as well or better than" the predicates.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This is a material-based medical device (dental adhesive), not a machine learning model. There is no "training set" in the context of an AI algorithm. Its development would involve material science research and formulation optimization, not data-driven model training.

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

Ground Truth for Training Set: Not applicable, as there is no training set for a machine learning model. The "ground truth" for the development of the adhesive would stem from dental material science principles, empirical testing during product development, and established industry standards for adhesive performance and biocompatibility.

Summary

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510 ( k ) Summary

K972858

Statement of Safety an Effectiveness

SEP 2 6 1997

Kerr Nexus One Bottle Adhesive

Submitter

Sybron Dental Specialties Inc. 1717 West Collins Avenue Orange, CA 82867 (714) 516-7486 - Phone (714) 516-7488 - Fax William R. Pike - contact Person

Device Name

Trade Name: Not yet Determined Common Name: One Bottle direct and indirect all-purpose dental adhesive Classification Name: Resin Tooth Bonding Agent, 76KLE, Class II, CFR872.3200 Classification: Dental Device Panel

Devices for which Substantial Equivalence is claimed

Prime & Bond 2.1 ( Product of Dentsply International Inc. ) One-Step ( Product of BISCO, Inc. )

Background

Kerr/Dental Materials Center currently manufactures a product marketed under the Trade name Nexus Universal Luting System ( 510 (k) Reference K954762). It is used by dentist to cement pre-fabricated restoration to the tooth. Kerr Nexus one bottle system is simply

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the replacement of the existing three-bottle system into one bottle system. This is a product based on the requests from the customers for a simple bonding system.

Safety

The safety of Kerr Nexus One Bottle Adhesive has been demonstrated by subjecting cured samples of the adhesive to various types of biocompatibility tests as recommended in the ISO 10993 biocompatibility guidance standard. These tests were conducted by an independent laboratory which specializes in safety and toxicity evaluation. No unknown chemical component is used in this device.

Independent Laboratory Evaluation by Toxicon Corporation

A.) Cytotoxicity Study ( MEM Elution Method USP23 )
B.) Mutagenicity : Salmonella Typhimurium REVERSE MUTATION ASSAY ( Ames Test )

EFFICACY

Effectiveness or suitability to intended purpose of Kerr Nexus One Bottle Adhesive has been demonstrated by a combination of in-house testing and side by side test comparisons to predicate products currently on the market. Results of this bench testing indicates that Kerr Nexus One Bottle Adhesive performs as well or better than PRIME & BOND 2.1 and ONE-STEP, two predicate devices currently on the market and being represented as one step all-purpose dental adhesives.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

SEP 26 1997

Mr. William R. Pike Regulatory Affairs Specialist Regulator) Dental Specialities, Incorporated 1717 W. Collins Avenue Orange, California 92667

K972858 Re : Kerr Nexus One Bottle Adhesive Trade Name: Regulatory Class: II Product Code: KLE Dated: August 4, 1997 Received: August 4, 1997

Dear Mr. Pike:

We have reviewed your Section 510(k) notification of intent to we have reviewed referenced above and we have determined the marroo is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the oommerco pevice Amendments, or to devices that have been realer soles in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Failure to Administration (FDA) will verify such assumptions. comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531

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Page 2 - Mr. Pike

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timo 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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510 (k) Number: K972858

Device Name : Kerr Nexus One Bottle Adhesive

Indications For Use : Kerr Nexus One Bottle Adhesive is indicated for all applications where a simple, dependable adhesive is required to bond etched natural tooth structure to composite restorative materials, porcelain, and both precious and non-precious metals.

(Dension Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K972858

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.