NEXUS 2

K992160 · Sybron Dental Specialties, Inc. · EMA · Aug 18, 1999 · Dental

Device Facts

• Record ID: K992160
• Device Name: NEXUS 2
• Applicant: Sybron Dental Specialties, Inc.
• Product Code: EMA · Dental
• Decision Date: Aug 18, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of Nexus 2 is for luting inlays, crowns, bridges, porcelain veneers and endodontic posts.

Device Story

Nexus 2 is a dual-cured (chemical and light-cured), resin-based dental cement. It is supplied as a two-part, base/catalyst paste system. The device is used by dental professionals in a clinical setting to lute (cement) indirect restorations, including inlays, onlays, crowns, bridges, porcelain veneers, and endodontic posts. The clinician mixes the two-part paste and applies it to the restoration or tooth surface to provide adhesion. The dual-cure mechanism allows for polymerization via light activation or chemical reaction, ensuring setting in areas where light may not reach. This facilitates secure attachment of dental prosthetics, improving restoration retention and patient oral function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Dual-cured (chemical and light-cured) resin-based dental cement. Two-part, base/catalyst paste/paste system. Class II device (21 CFR 872.3275).

Indications for Use

Indicated for luting inlays, crowns, bridges, porcelain veneers, and endodontic posts in dental patients.

Regulatory Classification

Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

Predicate Devices

• Nexus Universal Luting Cement (Kerr Corporation)

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the logo for Sybron Dental Specialties, Inc. The word "SYBRON" is in large, bold, black letters at the top of the image. Below that, in smaller, bold, black letters, are the words "DENTAL SPECIALTIES, INC."

# Section III - 510(k) Summary of Safety and Effectiveness

## Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 [phone] - Phone [phone] - Facsimile Colleen Boswell - Contact Person

Date Summary Prepared: June 1999

## Device Name:

- . Trade Name - Nexus 2
- Common Name - Luting Cement
- Classification Name -- Dental Cement, per 21 CFR § 872.3275 .

## Devices for Which Substantial Equivalence is Claimed:

- Kerr Corporation, Nexus Universal Luting Cement .
### Device Description:

The device is a dual cured, chemical and light cured, dental cement designed to be used for luting inlays, onlays, crowns, bridges, porcelain veneers and endodontic posts. Nexus 2 is a two-part, base/catalyst - paste/paste, system.

### Intended Use of the Device:

The intended use of Nexus 2 is for luting inlays, crowns, bridges, porcelain veneers and endodontic posts.

### Substantial Equivalence:

Nexus 2 is substantially equivalent to other legally marketed devices in the United States. The modified formulation of Nexus functions in a manner similar to and is intended for the same use as the original Nexus formula currently manufactured by Kerr Dental Materials Center.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Image /page/1/Picture/3 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus-like symbol with three wavy lines, representing health and well-being. Encircling the symbol are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

AUG 1 8 1999

AUG 1 8 1999

Ms. Colleen Boswell Manager, Requlatory Affairs Sybron Dental Specialties Incorporated 1717 West Collins Avenue Orange, California 92867

K992160 Re : Trade Name: Nexus 2 Requlatory Class: II Product Code: EMA Dated: June 24, 1999 Received: June 24, 1999

Dear Ms. Boswell:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device 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 Medical Device Amendments, or to devices that have been reclassified 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 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements 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 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Ms. Boswell

This letter will allow you to begin marketing your device as Inis lected will arow you on begdescribed in your siews, e of your device to a legally marketed or subscantial equiration a classification for your device and predicate acrisour device to proceed to the market. ends, bermine for your device for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in xİtro regulation (ar crx rais ase contact the Office of Compliance at Additionally, for questions on the promotion and [phone]. advertising of your device, please contact the Office of Also, please note the regulation Compliance at [phone]. entitled, "Misbranding by reference to premarket notification" (21 Other general information on your responsibilities CFR 807.97). under the Act may be obtained from the Division of Small anael one not may at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Latino Cucariffox

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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Section I - Indications for Use

510(k) Number:

K992160

Device Name: Nexus 2

Indications for Use:

Nexus 2 is a dual cured, resin-based, dental cement designed to be used for luting inlays, Nexus 2 13 a addr Carou, porcelain veneers and endodontic posts.

Suver Runn

(Division Sign-Off) Division of Dental, Inf and General Hospita 510(k) Number