ESTELITE SIGMA QUICK is is a light cured, radiopaque, submicron-filled composite resin for use in anterior and posterior restorations and is indicated for all carious classes.
For use as a tooth shade resin in dental procedures.

Device Description

ESTELITE SIGMA QUICK is is a light cured, radiopaque, submicron-filled composite resin for use in anterior and posterior restorations.
The chemical structure of ESTELITE SIGMA QUICK is nearly identical to Tokuyama's own ESTELITE SIGMA (a modification of K#980051) and ESTELITE FLOW QUICK (K#051808). ESTELITE SIGMA QUICK is formulated to shorten the curing time of the resin material compared to ESTELITE SIGMA.

AI/ML Overview

This document describes the 510(k) summary for ESTELITE SIGMA QUICK, a tooth shade resin material. The device is intended for use in anterior and posterior restorations and for all carious classes.

Based on the provided text, a conventional acceptance criteria table and detailed study information as typically seen for AI/ML device submissions cannot be generated. This is because the submission is for a dental material, not an AI/ML powered device. The "study" referenced in the document is a substantial equivalence determination rather than a clinical trial with performance metrics.

Here's a breakdown based on the provided text, explaining why certain sections cannot be fulfilled:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (from document)	Reported Device Performance (from document)
Substantial Equivalence	Demonstrates substantial equivalence to legally marketed predicate devices.	The chemical structure is "nearly identical" to ESTELITE SIGMA (K#980051) and ESTELITE FLOW QUICK (K#051808). Differences "do not raise new questions of safety or effectiveness."
Intended Use	For use in anterior and posterior restorations and all carious classes.	Matches the stated Intended Use.
Curing Time	Shorten the curing time compared to ESTELITE SIGMA.	ESTELITE SIGMA QUICK is "formulated to shorten the curing time of the resin material compared to ESTELITE SIGMA." (Note: No specific quantitative performance metric is provided for the reduction in curing time).
Radiopacity	Radiopaque	Radiopaque (stated in "Intended Use" description)

Rationale: The provided text is a 510(k) summary for a dental material (resin), not an AI/ML device. Therefore, the "acceptance criteria" are based on demonstrating substantial equivalence to predicate devices and meeting general material properties. There are no performance metrics like sensitivity, specificity, or AUC which would be relevant for an AI/ML diagnostic or therapeutic device. The "reported device performance" is descriptive of its characteristics relative to its predicates and intended function.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable and not provided in the document because this 510(k) pertains to a medical device material (tooth shade resin) and not an AI/ML-powered diagnostic or therapeutic device that would typically undergo testing with a 'test set' of data. The assessment here is based on chemical composition and material properties compared to predicate devices, not on the analysis of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable and not provided in the document. As explained above, this is for a dental material, not an AI/ML device requiring expert-established ground truth on a test set of data. The FDA's assessment is based on the provided chemical and physical properties and comparison to predicate devices, not on expert interpretations of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not provided in the document. There is no 'test set' in the context of an AI/ML device validation that would require an adjudication method.

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 information is not applicable and not provided in the document. MRMC studies are specific to evaluating the impact of AI on human reader performance, which is not relevant for a dental material like ESTELITE SIGMA QUICK.

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

This information is not applicable and not provided in the document. "Standalone algorithm performance" refers to the performance of an AI/ML algorithm on its own, which is not relevant for a dental material.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not applicable and not provided in the document. The concept of "ground truth" as used in AI/ML device evaluations (e.g., pathology, clinical outcomes, expert consensus on images) is not relevant for the substantial equivalence determination of a dental material. The "truth" in this context is based on the known properties and safety of the predicate devices and the chemical and physical characterization of the new device.

8. The sample size for the training set

This information is not applicable and not provided in the document. There is no 'training set' for a dental material. This concept is relevant for AI/ML models that learn from data.

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

This information is not applicable and not provided in the document. As there is no training set, there is no ground truth establishment for it.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" in this context is the 510(k) premarket notification process for demonstrating substantial equivalence. The manufacturer, Tokuyama Dental Corporation, presented information to the FDA to show that the ESTELITE SIGMA QUICK is substantially equivalent to their own legally marketed predicate devices: ESTELITE SIGMA (K#980051 as modified) and ESTELITE FLOW QUICK (K#051808).

Key elements of this "study" as described in the document:

Comparison of Chemical Structure: The document states, "The chemical structure of ESTELITE SIGMA QUICK is nearly identical to Tokuyama's own ESTELITE SIGMA... and ESTELITE FLOW QUICK..."
Discussion of Differences: While the ESTELITE SIGMA QUICK has a "slightly different chemical formulation," the manufacturer asserted that "these differences do not raise new questions of safety or effectiveness." One key difference highlighted is that ESTELITE SIGMA QUICK is "formulated to shorten the curing time of the resin material compared to ESTELITE SIGMA."
Intended Use Alignment: The intended use for ESTELITE SIGMA QUICK (anterior and posterior restorations, all carious classes, radiopaque, light-cured) aligns with the typical uses of such dental materials and presumably with its predicates.
FDA Review: The FDA reviewed the submitted information and determined that the device is "substantially equivalent" to the legally marketed predicate devices, thereby allowing it to proceed to market. The FDA's issuance of the substantial equivalence determination serves as the "proof" that the device meets the regulatory acceptance criteria for market authorization.

It's crucial to understand that this is a material science and regulatory compliance "study," not a clinical performance study as would be conducted for an AI/ML diagnostic device.

Summary

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KO 80940

510(k) SUMMARY Tokuyama Dental Corporation ESTELITE SIGMA QUICK

JUN 19 2008

Name of Device

Trade or Proprietary Name: Common Name: Classification Name: Product Code:

ESTELITE SIGMA QUICK tooth shade resin material material, tooth shade, resin EBF

Preparation Date

March 28, 2008

510(k) Sponsor

Tokuyama Dental Corporation 38-9 Taitou 1-chome, Taitou-ku Tokyo 110-0016 Japan

510(k) Sponsor Contact

Keith A. Barritt Fish & Richardson P.C. 1425 K Street, N.W., Suite 1100 Washington, DC 20005 Phone: (202) 783-5070 Facsimile: (202) 783-2331

Intended Use

ESTELITE SIGMA QUICK is is a light cured, radiopaque, submicron-filled composite resin for use in anterior and posterior restorations and is indicated for all carious classes.

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Technological Characteristics and Substantial Equivalence

The chemical structure of ESTELITE SIGMA QUICK is nearly identical to Tokuyama's own ESTELITE SIGMA (a modification of K#980051) and ESTELITE FLOW QUICK (K#051808). ESTELITE SIGMA QUICK is formulated to shorten the curing time of the resin material compared to ESTELITE SIGMA.

The ESTELITE SIGMA QUICK is substantially equivalent, for purposes of FDA market authorization, to Tokuyama's own ESTELITE SIGMA (K#980051 as modified) and ESTELITE FLOW QUICK (K#051808). Although the ESTELITE SIGMA QUICK has a slightly different chemical formulation than either product, these differences do not raise new questions of safety or effectiveness, as discussed below.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 9 2008

Tokuyama Dental Corporation C/O Mr. Keith A. Barritt, Esq. Fish & Richardson P.C. 1425 K Street, N.W., Suite 1100 Washington, DC 20005

Rc: K080940

Trade/Device Name: ESTELITE SIGMA QUICK Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: April 2, 2008 Received: April 4, 2008

Dear Mr. Barritt:

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.

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Page 2- Mr. Barritt

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 (Scctions 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 (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sutie y. Mickeonds

Chiu Lin, Ph.D. 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

510(k) Number (if known): K080940

Device Name: Estelite Sigma Quick

Indications for Use:

For use as a tooth shade resin in dental procedures.

Prescription Use X (21 CFR Part 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suren Russo

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

Page 1 of

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.