Nexus 2 Modified is a dual cured, resin-based, dental cement designed to be used for luting inlays, onlays, crowns, bridges, porcelain veneers and endodontic posts.

Device Description

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

AI/ML Overview

The provided text is a 510(k) summary for a dental luting cement, Nexus 2 Modified. It focuses on establishing substantial equivalence to a predicate device based on its intended use and functional similarities, rather than presenting a study with acceptance criteria and device performance metrics. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics is not available in the given document.

Here's a breakdown of what can be extracted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not available in the provided document. The 510(k) summary for Nexus 2 Modified describes the device and its intended use, focusing on demonstrating substantial equivalence to a predicate device (Nexus 2). It does not present specific acceptance criteria or quantitative performance data from a prospective study to assess the device's performance against such criteria.

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

This information is not available in the provided document. The submission focuses on functional characteristics and intended use for substantial equivalence, not a clinical or performance study with a test set.

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

This information is not available in the provided document. No test set requiring expert ground truth establishment is described.

4. Adjudication Method for the Test Set

This information is not available in the provided document.

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

No, an MRMC comparative effectiveness study was not done or at least not described in this 510(k) summary. The submission is for a dental luting cement, which typically does not involve human readers interpreting images, and thus an MRMC study would not be relevant.

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

This information is not applicable/available. The device is a dental luting cement, not an algorithm or AI-powered device.

7. The Type of Ground Truth Used

This information is not applicable/available. There is no ground truth, expert consensus, pathology, or outcomes data described in relation to a study in this document. The "ground truth" in the context of this 510(k) is the established performance and safety of the predicate device, which Nexus 2 Modified aims to be substantially equivalent to.

8. The Sample Size for the Training Set

This information is not applicable/available. As the device is a dental cement, not an AI or algorithm, there is no "training set" in the computational sense.

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

This information is not applicable/available.

Summary of available information from the document:

The 510(k) summary for Nexus 2 Modified focuses on demonstrating substantial equivalence to the original Nexus 2 formulation manufactured by Kerr Corporation. The device is a dual-cured, resin-based dental cement for luting inlays, onlays, crowns, bridges, porcelain veneers, and endodontic posts. The document does not describe any studies with acceptance criteria, performance metrics, test sets, or ground truth establishment typically associated with medical device performance evaluations or AI/algorithm submissions. The FDA's letter states that the device is substantially equivalent based on the indications for use.

Summary

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OCT - 2 2001

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

Submitter:

Sybron Dental Specialties, Inc. 1717 W. Collins Avenue Orange, California 92867 (714) 516-7484 - Phone (714) 516-7488 - Facsimile Colleen Boswell - Contact Person

Date Summary Prepared: August 2001

Device Name:

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

Devices for Which Substantial Equivalence is Claimed:

Kerr Corporation, Nexus 2 o

Device Description:

Intended Use of the Device:

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

Substantial Equivalence:

Nexus 2 Modified is substantially equivalent to other legally marketed devices in the United States. Nexus 2 Modified functions in a manner similar to and is intended for the same use as the original Nexus 2 formulation that is currently manufactured by Kerr Corporation.

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Image /page/1/Picture/1 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" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three overlapping wings, creating a sense of movement or flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 2 2001

Ms. Colleen Boswell Director, Corporation Compliance Sybron Dental Specialties, Incorporated 1717 West Collins Avenue Orange, California 92867

Re: K013008

Trade/Device Name: Nexus 2 Modified Regulation Number: 872.3274 Regulation Name: Luting Cement Regulatory Class: II Product Code: EMA Dated: August 31, 2001 Received: September 6, 2001

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 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.

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Page 2 - Ms. Boswell

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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" (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

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KO13008

Section I

Indications for Use Statement

Ver/ 3 - 4/24/96

Applicant: Kerr Dental Materials Center

Labels	Values
510(k) Number (if known):	K0/3008
Device Name:	Nexus 2 Modified

Indications For Use:

Nexus 2 Modified is a dual cured, resin-based, dental cement designed to be used for luting
inlays, onlays, crowns, bridges, porcelain veneers and endodontic posts.

Susan Runne
(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices

Labels	Values
510(k) Number	K0/3008

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)
(Optional Format 1-2-96)

Regulation Number and Section

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)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.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. 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.(2)
Classification. Class II.