EsTemp NE is light-curing temporary filling materials. It has characteristics of high elasticity and high compressive strength. This elastic consistency assures easy removal from cavity, even in case of undercuts, final treatment of cavity is not necessary.

AI/ML Overview

This document describes the EsTemp NE dental cement, and its evaluation for substantial equivalence to a predicate device. It is a 510(k) summary, which focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device. Therefore, the study described is a comparison study against a predicate device, not a standalone performance study with defined acceptance criteria in the same way one might evaluate a novel AI algorithm.

However, based on the provided text, we can infer and construct elements related to acceptance criteria and the "study" (which is a comparative analysis in this context).

1. Table of Acceptance Criteria and Reported Device Performance

Because this is a 510(k) submission for a dental cement, the acceptance criteria are primarily based on demonstrating comparable performance to a predicate device across key characteristics. The "performance" is the new device's properties as compared to the predicate.

Acceptance Criteria (Inferred from 510(k) Equivalence)	Reported Device Performance (EsTemp NE vs. TempBond NE)
Similar Intended Use: Cementation of temporary and provisional restorations.	EsTemp NE's indication for use is "Cementation of temporary and provisional restoration such as crowns, bridges, inlay and onlay," which is consistent with the general intended use of dental cements like the predicate, TempBond NE. The document explicitly states: "EsTemp NE has the similar device characteristics as the predicate device, the TempBond NE; intended use... are similar."
Similar Material/Chemical Composition/Design: Material compositions and design principles should be comparable.	The document states: "EsTemp NE is similar to other commercially available products based on the ... material composition employed and performance characteristics. They are substantially equivalent in design, function and intended use to the predicate devices." Also, "EsTemp NE has the similar device characteristics as the predicate device, the TempBond NE; ...material, chemical composition, design and use concept are similar."
Comparable Mechanical Properties: Key physical properties relevant to dental cement function should be similar to the predicate.	The document states: "EsTemp NE have the similar mechanical properties as the predicate device: compressive strength, flexural strength, flow thickness, wear, polymerization shrinkage and thermal expansion coefficience." While specific values are not provided in this summary, the claim of "similar" indicates that these properties met the acceptance range for substantial equivalence.
Safety Data/Biocompatibility: The device should be safe for its intended use, typically demonstrated through biocompatibility testing.	The document states: "Safety tests including biocompatibility have been performed to ensure the devices comply with the US regulations and ISO 3107." This demonstrates that safety, a fundamental acceptance criterion, was met.

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

The provided 510(k) summary does not specify sample sizes for the empirical tests (e.g., for compressive strength, flexural strength, etc.) comparing EsTemp NE to TempBond NE.

Data Provenance: The company, SPIDENT Co., Ltd., is located in Incheon, Korea. It is highly probable that the data was generated in Korea, but the summary does not explicitly state the country of origin of the raw test data. The study is retrospective in the sense that the data was collected to support an existing product for market clearance, rather than a prospective trial with human subjects. However, the tests themselves (mechanical properties, biocompatibility) would have involved newly created samples of the EsTemp NE and predicate for direct comparison.

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

This type of information is not applicable to this 510(k) submission. Dental cement testing for substantial equivalence relies on objective, quantifiable physical and chemical property comparisons, and biocompatibility studies. It does not involve "expert ground truth" in the way an AI diagnostic device would with image annotations.

4. Adjudication Method for the Test Set

This is not applicable as the "test set" involves objective laboratory measurements, not subjective expert reviews requiring adjudication.

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

This is not applicable. This submission is for a dental cement, not an AI or diagnostic imaging device that would involve human readers or AI assistance.

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

This is not applicable as the device is a physical dental cement, not an algorithm.

7. The Type of Ground Truth Used

For this dental cement, the "ground truth" for comparison against the predicate device is established by:

Standardized Laboratory Measurements: Utilizing established ASTM, ISO, or similar standards for testing properties like compressive strength, flexural strength, flow thickness, wear, polymerization shrinkage, and thermal expansion coefficient.
Biocompatibility Standards: Compliance with ISO 3107 (and likely other relevant ISO standards for medical device biocompatibility).
Predicate Device Performance: The established performance characteristics of the legally marketed predicate device (TempBond NE) serve as the benchmark for "truth" in terms of what constitutes acceptable performance for this class of device.

8. The Sample Size for the Training Set

This is not applicable. Dental cements are not "trained" in the way AI algorithms are. Their performance is inherent in their material composition and manufacturing process.

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

This is not applicable for the reasons stated above.

Summary

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Image /page/0/Picture/0 description: The image shows a logo with the word "SPIDENT" inside a rectangular box. The letters are in a simple, sans-serif font. The box is outlined with a thick black line, and there is a small gap in the top right corner of the box.

SPIDENT Co., Ltd. #312. 151B-6L. NamdongKongDan, Incheon, Korea 405-821 Tel: +82(32)819-4570 Fax : +82(32)819-4572

11/00290

FEB 1 7 2010

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92(c).

Date: November 27, 2009

Company and Correspondent making the submission:

	Company
Name	SPIDENT Co., Ltd.
Address	#312, 151B-6L, NamdongKongDan,Incheon, Korea 405-821
PhoneFax	+82(32)819-4570+82(32)819-4572
Contact	K. H. Baek

1. Device:
  Proprietary Name - EsTemp NE Common Name - Dental Cement Classification Name - Cement, Dental
1. Predicate Device: TempBond NE, K894219
1. Classifications Names & Citations: EMA, 872.3275
1. Description:

The EsTemp NE is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. They are substantially equivalent in design, function and intended use to the predicate devices.

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Image /page/1/Picture/0 description: The image shows the word "SPIDENT" in a stylized font. The word is enclosed in a rectangular box with a break in the top and bottom lines between the "D" and "E". The font is sans-serif and appears to be a custom design. The overall design is simple and clean, with a focus on the word itself.

SPIDENT Co., Ltd. #312, 151B-6L, NamdongKongDan, Incheon, Korea 405-821 Tel: +82(32)819-4570 Fax : +82(32)819-4572

6. Indication for use:

Cementation of temporary and provisional restoration such as crowns, bridges, inlay and onlay.

7. Review:

EsTemp NE has the similar device characteristics as the predicate device, the TempBond NE; intended use, material, chemical composition, design and use concept are similar.

EsTemp NE have the similar mechanical properties as the predicate device: compressive strength, flexural strength, flow thickness, wear, polymerization shrinkage and thermal expansion coefficience.

EsTemp NE has been subjected to extensive safety, performance, and product validations prior to release. Safety tests including biocompatibility have been performed to ensure the devices comply with the US regulations and ISO 3107.

Based on the comparison of intended use and technical features, the EsTemp NE is substantially equivalent to the predicate devices.

8. Conclusions:

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, FDA's "Guidance for the Preparation of Premarket notifications for Dental Composite" and based on the information provided in this premarket notification SPIDENT Co., Ltd. concludes that the EsTemp NE is safe and effective and substantially equivalent to predicate devices as described herein.

1. SPIDENT Co., Ltd. will update and include in this summary any other information deemed reasonably necessary by the FDA.
  END

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002

Spident Company Limited C/O Mr. Marc M. Mouser Responsible Third Party Official Underwriters Laboratories, Incorporated 2600 NW Lake Road Camas, Washington 98607-9526

FEB 1 7 2010

Re: K100290

Trade/Device Name: EsTemp NE Regulation Number: 21CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: January 19, 2010 Received: February 2, 2010

Dear Mr. Mouser:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2- Mr. Mouser

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDeviccs/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours

Susan Punney

Anthony D. Watson, B.S., M.S., M.B.A. 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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K100290 510(k) Number K _

Device Name: EsTemp NE

Indication for use:

Cementation of temporary and provisional restoration such as crowns, bridges, inlay and onlay.

Prescription Use (Per 21CFR801 Subpart D) AND/OR Over-The-Counter Use (Per 21CFR807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Starr

(Division Sign-Off) Division of Anesthesiology. General Hoapital Infection Control. Dental Devices

510(k) Number: K100290

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.