The device is a non-eugenol temporary cement that is used for the cementation of temporary restorations. Temp-Bond NE 2 is a two-part, base/catalyst - paste/paste system. The product will not inhibit the set of permanent resin cements or soften acrylic temporary restorations. Temp-Bond NE 2 is indicated for patients who are allergic to eugenol.

AI/ML Overview

The provided 510(k) summary for Temp-Bond NE 2 does not contain the information requested regarding acceptance criteria and performance studies in the specific format required.

This document is a premarket notification (510(k)) submission to the FDA. Such submissions primarily focus on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting extensive performance study data against pre-defined acceptance criteria, especially for a Class II device like a temporary dental cement. The focus is on comparing the new device's characteristics (materials, intended use, and performance) to the predicate.

Therefore, I cannot populate the table or answer most of the questions based on the provided text.

Here is what I can extract and the reasons why other information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in the document	Not specified in the document

Reasoning: The document states that "The modified formulation of Temp-Bond NE functions in a manner identical to and is intended for the same use as the original Temp-Bond NE formula currently manufactured by Kerr Corporation." This statement serves as the primary basis for demonstrating substantial equivalence. It implies that the performance of Temp-Bond NE 2 is expected to be the same as the predicate, but it does not define specific, quantifiable acceptance criteria or present performance data from a dedicated study.

2. Sample size used for the test set and the data provenance

Sample size: Not specified.
Data provenance: Not applicable, as no specific performance study with a test set is described. The comparison is based on the new device's formulation and intended use being identical to the predicate.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of experts: Not applicable.
Qualifications of experts: Not applicable.

Reasoning: No test set or ground truth establishment by experts is described for this submission. The "ground truth" for substantial equivalence is based on the established performance and safety of the predicate device.

4. Adjudication method for the test set

Adjudication method: Not applicable.

Reasoning: No test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC study: No.
Effect size: Not applicable.

Reasoning: This device is a temporary dental cement, not an AI-powered diagnostic device. MRMC studies are not relevant to its type of evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone study: No.

Reasoning: This is not an algorithm-based device.

7. The type of ground truth used

Type of ground truth: The "ground truth" for this 510(k) is the established safety and effectiveness of the legally marketed predicate device (Kerr Corporation, Temp-Bond NE), to which Temp-Bond NE 2 is claimed to be substantially equivalent. This is not a ground truth derived from expert consensus, pathology, or outcomes data for a specific study of the new device.

8. The sample size for the training set

Sample size: Not applicable.

Reasoning: This submission does not describe an AI/ML-based device that would require a training set.

9. How the ground truth for the training set was established

Ground truth establishment: Not applicable.

Reasoning: As above, not an AI/ML-based device.

In summary, the provided 510(k) notification focuses on establishing substantial equivalence to a predicate device, which is a different regulatory pathway than demonstrating performance against specific acceptance criteria through a dedicated clinical or performance study for a novel device or an AI/ML product.

Summary

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K003658

JAN - 4 2001

Image /page/0/Picture/2 description: The image shows a logo for "sds Kerr Sybron Dental Specialties". The logo is black and white and features the text "sds Kerr" in a bold, sans-serif font. The text "SYBRON DENTAL SPECIALTIES" is below the main text in a smaller font. There is a curved line above the text, which is part of the logo design.

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: November 2000

Device Name:

Trade Name Temp-Bond NE 2 .
Common Name - Temporary Dental Cement
Classification Name Dental Cement Other Than Zinc-Oxide Eugenol, per 21 CFR & . 872.3275 (b)

Devices for Which Substantial Equivalence is Claimed:

. Kerr Corporation, Temp-Bond NE

Device Description:

Intended Use of the Device:

The intended use of Temp-Bond NE 2 is for the cementation of temporary restorations.

Substantial Equivalence:

Temp-Bond NE 2 is substantially equivalent to other legally marketed devices in the United States. The modified formulation of Temp-Bond NE functions in a manner identical to and is intended for the same use as the original Temp-Bond NE formula currently manufactured by Kerr Corporation.

1717 West Collins Avenue, Orange, (AS2867 800-KERRI23 714-516-7400

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows a black and white seal for the Department of Health & Human Services - USA. The seal is circular with text around the perimeter. Inside the circle is a stylized image of an eagle.

JAN - 4 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re : K003658 Temp-Bond NE 2 Trade Name: Requlatory Class: II Product Code: EMA Dated: November 22, 2000 November 28, 2000 Received:

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 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). 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 Current Good Manufacturing Practice requirements, 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 Administration (FDA) will verify such assumptions. Failure to 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 obligation you might have under sections 531 through 542 of the Act for devices under the Electronic

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Page 2 - Ms. Boswell

Product Radiation Control provisions, or other Federal laws or regulations.

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) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note "Misbranding by reference to the regulation entitled, premarket notification" (21CFR 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/dsma/dsmamain.html".

Sincerely yours.

Timotheus Hlabiskin

Ulatowski Timo Directo 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:

K003658

Device Name: Temp-Bond NE 2

Indications for Use:

Temp-Bond NE is a non-eugenol temporary cement used for the cementation of temporary restorations.

Susan Rumser

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Pr 0036 ビイC(k) Number _

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.