KERR NEXUS ONE BOTTLE ADHESIVE

K972858 · Sybron Dental Specialties, Inc. · KLE · Sep 26, 1997 · Dental

Device Facts

• Record ID: K972858
• Device Name: KERR NEXUS ONE BOTTLE ADHESIVE
• Applicant: Sybron Dental Specialties, Inc.
• Product Code: KLE · Dental
• Decision Date: Sep 26, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended 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.

Device Story

Kerr Nexus One Bottle Adhesive is a visible light-curable, methacrylate resin-based dental adhesive. It functions as a single-step bonding agent to create chemical and mechanical bonds between natural tooth structures and restorative materials (composite, porcelain, metals). The organic solvent component facilitates flow into micro-fissures; upon solvent evaporation, a thin resin layer remains to form a tight interface. Used by dentists in clinical settings for restorative techniques. The device simplifies the bonding process by consolidating a previously multi-bottle system into a single-bottle application, improving clinical efficiency and ease of use.

Clinical Evidence

Bench testing only. Biocompatibility evaluated via Cytotoxicity (MEM Elution Method USP23) and Mutagenicity (Salmonella Typhimurium Reverse Mutation Assay/Ames Test). Efficacy demonstrated through side-by-side bench testing comparisons against predicate devices (Prime & Bond 2.1 and One-Step).

Technological Characteristics

Visible light-curable methacrylate resin-based monomer mixture. Single-bottle, single-step application. Solvent-based delivery system. Biocompatibility tested per ISO 10993. Class II dental device (Resin Tooth Bonding Agent).

Indications for Use

Indicated for bonding etched natural tooth structure (enamel and dentin) to composite restorative materials, porcelain, and precious/non-precious metals in dental restorative procedures.

Regulatory Classification

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.

Predicate Devices

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

Reference Devices

• Nexus Universal Luting System (K954762)

Submission Summary (Full Text)

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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 [phone] - Phone [phone] - 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 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.

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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