Direct restorations for all cavity classes in anterior and posterior teeth
Direct veneers
Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.)
Intraoral repairs of fractured restorations

Device Description

The subject device, CLEARFIL MAJESTY ES-2, is a light-cure, radiopague restorative material which provides accurate color matching, high polishability and excellent physical properties, making it ideal for both anterior and posterior restorations. It is formulated with optimal viscosity assuring easy handling and placement. It is packaged in traditional svringes or Pre-loaded tips (PLTs). The lightness/ value based unique shade taking system of its Shade guide provides shade taking options for single (Classic) and dual (Premium) shade lavering for highly esthetic restorations.

AI/ML Overview

The provided document is a 510(k) summary for a dental restorative material (CLEARFIL MAJESTY ES-2) and does not describe a study involving an AI/CADeX device or its performance against acceptance criteria in the way typically expected for such devices (e.g., sensitivity, specificity, AUC).

Instead, this document focuses on proving substantial equivalence to predicate devices based on intended use, chemical ingredients/safety, and physical/mechanical properties as measured against an industry standard (ISO 4049:2009).

Therefore, a table of acceptance criteria and device performance, as well as details regarding sample sizes, ground truth establishment, expert involvement, and MRMC studies, are not applicable in the context of this device's submission and the information provided.

However, I can extract the relevant information regarding how the device's "effectiveness/performance" was established for its substantial equivalence claim:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Compliance with ISO 4049: 2009 for Polymer-based Restorative Materials	The subject device, CLEARFIL MAJESTY ES-2, "complies with all requirements of ISO 4049: 2009."
Substantial equivalence to predicate devices (CLEARFIL MAJESTY Esthetic and CLEARFIL MAJESTY Flow) based on ISO 4049: 2009.	The subject device and the predicate device comply with ISO 4049: 2009, indicating substantial equivalence in safety and effectiveness.

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

Not Applicable. The document describes a comparison against an international standard (ISO 4049:2009) for physical and mechanical properties, not a clinical test set with patient data. The standard itself would specify testing methodologies and sample sizes for various properties, but these details are not provided in this 510(k) summary.

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

Not Applicable. Ground truth, in the context of a medical device involving clinical assessment or image interpretation, is not relevant here. The "ground truth" for this device's performance is adherence to the physical and mechanical property specifications outlined in ISO 4049:2009. This standard is established by technical committees.

4. Adjudication method for the test set:

Not Applicable. There was no "test set" in the sense of a set of cases requiring adjudication by experts.

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:

Not Applicable. This device is a dental restorative material, not an AI/CADeX system for diagnostic assistance. No MRMC study was performed or is relevant.

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

Not Applicable. This device is a dental restorative material, not an algorithm or AI system.

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

The "ground truth" or reference standard for evaluating the device's technical performance was adherence to the physical and mechanical property specifications defined by the international standard ISO 4049:2009 for polymer-based restorative materials.

8. The sample size for the training set:

Not Applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not Applicable. There is no "training set" for this type of device.

Summary

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[CLEARFIL MAJESTY ES-2, Kuraray Noritake Dental Inc.] Section 3: Summary

Date:

510(k) Summary

3-1. 510(k) owner (submitter) 1) Name

Address
Contact person
Contact person in U.S.

Kuraray Noritake Dental Inc.

1621 Sakazu. Kurashiki, Okayama 710-0801. Japan

Michio Takigawa · Quality Assurance Department

Kiyoyuki Arikawa KURARAY AMERICA INC. 33 Maiden Lane, 6th Floor, New York, NY 10038 Tel: (212)-986-2230 (Ext. 115) or (800)-879-1676 Fax: (888)-700-5200

3-2. Name of Device 1) Trade / Proprietary name

Classification name
Common name

CLEARFIL MAJESTY ES-2

Tooth shade resin material (21 CFR section 872.3690. Product code: EBF)

Dental light-cured restorative composite

3-3. Predicate device 1) CLEARFIL MAJESTY Esthetic

2) CLEARFIL MAJESTY Flow

510(k) Number: Product Code: 21 CFR Section: Applicant: Inc.

K061860 EBF 872.3690 Kuraray Noritake Dental

510(k) Number: K063593 Product Code: EBF 872.3690 21 CFR Section: Applicant: Inc.

Kuraray Noritake Dental

JUL 25 2012

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3-4. Description of device

1. The subject device, CLEARFIL MAJESTY ES-2, is a light-cure, radiopague restorative material which provides accurate color matching, high polishability and excellent physical properties, making it ideal for both anterior and posterior restorations. It is formulated with optimal viscosity assuring easy handling and placement. It is packaged in traditional svringes or Pre-loaded tips (PLTs).
  The lightness/ value based unique shade taking system of its Shade guide provides shade taking options for single (Classic) and dual (Premium) shade lavering for highly esthetic restorations.

It is intended for the following indications:

[1]Direct restorations for all cavity classes in anterior and posterior teeth

[2]Direct veneers
[3]Correction of tooth position and tooth shape (c.g. diastema closure, dwarfed tooth. etc.)

[4]Intraoral repairs of fractured restorations

1. It is classified into tooth shade resin material (21 CFR section 872.3690, Product code: EBF ) according to 21 CFR § 872 since it is composed of materials such as Bisphenol A diglycidylmethacrylate (Bis-GMA).
1. Physical and mechanical properties of the subject device are evaluated according to ISO 4049: 2009 (Dentistry - Polymer-based restorative materials). According to ISO 4049: 2009, the subject device is classified into the following:
- Type 1: Polymer-based restorative materials;
- Class 2: materials whose setting is effected by light;
- Group 1: materials whose use requires the energy to be applied intra-orally.

3-5. Substantial Equivalence Discussion

l ) Intended uses

The INDICATIONS of the subject device were written up based on that of the predicate device. Therefore, the intended purposes of the subject device are substantially the same as that of the predicate one.

2) Chemical ingredients / Safety

All chemical ingredients of the subject device are equivalent to those of the predicate devices, CLEARFIL MAJESTY Esthetic and CLEARFIL MAJESTY Flow.

Regarding the predicate devices, there have not been any reported problems or recalls according to the post-market adverse event reporting requirements in the US.

3) Effectiveness / Performance

The subject device complies with all requirements of ISO 4049: 2009 as polymer-based restorative materials.

Regarding the comparison with the predicate device according to ISO 4049: 2009, the subject device and the predicate device comply with ISO 4049: 2009 indicating that the subject device is substantially equivalent in safety and effectiveness to the predicate device.

3-6. Biocompatibility

All the chemical ingredients of the subject device are equivalent to those of the predicate devices. CLEARFIL MAJESTY Esthetic and CLEARFIL MAJESTY Flow.

Regarding the predicate devices, there have not been any reported problems or recalls according to the post-market adverse event reporting requirements in the US. Accordingly, it was considered that the subject device was substantially equivalent in safety to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

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

JUL 25 2012

Kurarav Noritake Dental, Incrporated C/O Mr. Kiyoyuki Arikawa General Manger Kuraray America, Incorporated 33 Maiden Lane, 6th Floor New York, New York 10038

Re: K121583

Trade/Device Name: Clearfil Majesty ES-2 Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: May 28, 2012 Received: May 30, 2012

Dear Mr. Arikawa:

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. Arikawa

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/MedicalDevices/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,

Antimony A. mart

Anthony D. Watson, B.S., M.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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Indications for Use

K 12 1583 510(k) Number (if known):

Device Name: CLEARFIL MAJESTY ES-2

Indications for Use:

Direct restorations for all cavity classes in anterior and posterior teeth
Direct veneers
Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.)
Intraoral repairs of fractured restorations

Over-The-Counter Use Prescription Use イ N/A AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Deyice Evaluation (ODE)

Susan Rummer

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

510(k) Number: K121583

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.