NEXUS 3

K062519 · Kerr Corporation · EMA · Oct 19, 2006 · Dental

Device Facts

• Record ID: K062519
• Device Name: NEXUS 3
• Applicant: Kerr Corporation
• Product Code: EMA · Dental
• Decision Date: Oct 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Nexus 3 is a resin cement for the cementation of ceramic, resin, and metal-based veneers, inlays, onlays, crowns, bridges and posts, bonding of amalgam restorations, and as corebuildup material.

Device Story

Nexus 3 is a resin cement system used by dental professionals for restorative procedures. It consists of two delivery formats: a single-syringe light-cure veneer cement and a dual-syringe dual-cure all-purpose resin cement. The device is applied by a dentist in a clinical setting to bond dental restorations—including veneers, inlays, onlays, crowns, bridges, and posts—or to perform core buildups. It functions as a restorative material to secure dental prosthetics to tooth structure or to restore tooth integrity. The cement is cured via light or dual-cure mechanisms to provide mechanical retention and structural support for the restoration.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Resin cement system. Delivery formats: single-syringe light-cure and dual-syringe dual-cure. Intended for permanent cementation and core-buildup. Class II device (21 CFR 872.3275).

Indications for Use

Indicated for cementation of ceramic, resin, and metal-based veneers, inlays, onlays, crowns, bridges, and posts; bonding of amalgam restorations; and core-buildup material. For prescription use.

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 2

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a logo for Sybron Dental Specialties. The logo features the letters 'sds' in a stylized font, with a curved line above the letters. Below the letters, the words 'SYBRON DENTAL SPECIALTIES' are printed in a simple, sans-serif font. The logo is black and white.

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

Submitter:

OCT 1 9 2006

Sybron Dental Specialties, Inc. 100 Bayview Circle, Suite 6000 Newport Beach, California 92660 [phone] - Phone [phone] - Facsimile Colleen Boswell - Contact Person

Date Summary Prepared: August 2006

#### Device Name:

- . Trade Name - Nexus 3
- Common Name -- Dental Cement ●
- Classification Name Dental Cement, per 21 CFR § 872.3275 .

## Devices for Which Substantial Equivalence is Claimed:

- . Sybron Dental Specialties, Inc., Nexus 2
#### Device Description:

Nexus 3 is a resin cement system comprising of a single-syringe light-cure veneer cement and a dual-syringe dual-cure all-purpose resin cement.

#### Intended Use of the Device:

The intended use of Nexus 3 is as a resin cement for the cementation of ceramic, resin, and metal-based veneers, inlays, onlays, crowns, bridges and posts, bonding of conding of amalgam restorations, and as core-buildup material.

## Substantial Equivalence:

Nexus 3 is substantially equivalent to other legally marketed devices in the United States. Nexus 3 functions in a manner similar to and is intended for the same use as the product Nexus 2 cleared for marketing for Sybron Dental Specialties, Inc.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings. The eagle is positioned to the right of a circular inscription that reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## OCT 1 9 2006

Ms. Colleen Boswell Director, Corporate Compliance Sybron Dental Specialties, Incorporated 100 Bayview Circle, Suite 6000 Newport Beach, California 92660

Re: K062519

Trade/Device Name: Nexus 3 Regulation Number: 21 CFR 872.3275(b) Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: August 25, 2006 Received: August 29, 2006

Dear Ms. Boswell:

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 commence 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 coan. therefore, market the device, subject to the general controls provisions of the Act. To ameral controls provisions of the Act include requirements for annual registration, listing of levines, 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 an be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA nav publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Colleen Boswell

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. 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Chiu S. Lin, PhD

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use K062519

510(k) Number (if known):

Device Name: Nexus 3

### Indications For Use:

Nexus 3 is a resin cement for the cementation of ceramic, resin, and metal-based veneers, inlays, onlays, crowns, bridges and posts, bonding of amalgam restorations, and as corebuildup material.

× Prescription Use (Part 21 CFR 801 Subpart D)

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AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

*[Signature]*

| | Division of Anesthesiology, General Hospital |
|--|----------------------------------------------|
| | Infection Control, Dental Devices |
| | K062519 |

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