Direct restorations for anterior and posterior teeth (Class I - V cavities)
Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.)
Intraoral repairs of fractured crowns/bridges

Device Description

CLEARFIL MAJESTY Posterior is a light-cure, radiopaque restorative composite resin which provides accurate color matching, high polish ability and excellent physical properties, making it ideal for both anterior and posterior restorations. It is formulated with optimal viscosity assuring casy handling and placement.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: CLEARFIL MAJESTY Posterior (KURARAY MEDICAL INC.)
Device Type: Light-cure, radiopaque restorative composite resin (Tooth shade resin material)

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) submission leverages the concept of "substantial equivalence" to a predicate device (K063595). Therefore, the acceptance criteria are primarily based on meeting the same performance standards as the predicate device and complying with a recognized international standard.

Acceptance Criterion	Reported Device Performance
Intended Uses	The intended uses of the subject device (CLEARFIL MAJESTY Posterior) are identical to those of the predicate device.
Chemical Ingredients / Safety	All chemical ingredients of the subject device have been used in the predicate device. The chemical composition is "very similar" to the predicate device. This similarity suggests equivalent safety. The predicate device's safety was previously established and it had no reported problems or recalls for 2 years. Conclusion: Biologically safe.
Effectiveness / Performance (Physical/Mechanical Properties)	Evaluated according to ISO 4049: 2000 "Dentistry - Polymer-based filling, restorative and luting materials" in comparison with the predicate device. Both the subject device and the predicate device comply with ISO 4049:2000. This indicates that the subject device is "as effective as and performs as well as" the predicate device.
Biocompatibility	All chemical ingredients are the same as the predicate device. The predicate device's biocompatibility was established in its original application and it had no reported problems or recalls for 2 years post-market. Conclusion: Biologically safe.
Radiopacity	The device is described as "radiopaque," which is a property often required for restorative materials to be visible on radiographs. (While not explicitly listed as a test result, its mention in the description implies it meets the standard for this characteristic.)
Color Matching, High Polishability, Optimal Viscosity	These are described as characteristics of the device, implying they meet expected standards for clinical performance. Although quantitative acceptance criteria are not presented in this document, these attributes are inherent to the device's design and intended clinical benefits, aligning it with the performance expected of a "tooth shade resin material" for aesthetic and functional restorations.

2. Sample Size for Test Set and Data Provenance

The primary study cited is a comparison of physical and mechanical properties based on ISO 4049.

Sample Size (Test Set): Not explicitly stated in the provided text. The document mentions "physical and mechanical properties of the subject device were evaluated according to ISO 4049 in comparison with the predicate device." ISO standards typically define the number of samples required for specific tests, but the exact number used in this particular evaluation is missing.
Data Provenance: The study was conducted by KURARAY MEDICAL INC., which is based in Japan ("1621 Sakazu, Kurashiki, Okayama 710-0801, Japan"). The testing described appears to be prospective laboratory testing for the purpose of premarket submission.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. This submission relies on an equivalency study to a predicate device and compliance with an international standard (ISO 4049) for physical and mechanical properties. There is no mention of a clinical study or expert review to establish ground truth for a test set in the traditional sense, as this is a material science testing rather than a diagnostic or interpretive device.

4. Adjudication Method for Test Set

Not applicable. See point 3.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is a material science product; MRMC studies are typically for diagnostic imaging devices or algorithms where human interpretation is involved.

6. Standalone Performance Study

Yes, in essence. The evaluation of the device's physical and mechanical properties against ISO 4049 and in comparison to the predicate device can be considered a standalone performance study in the context of material science. The algorithm, in this case, is the material itself and its inherent properties.

7. Type of Ground Truth Used

ISO 4049: 2000 Standard Requirements: The primary ground truth for performance is the set of specifications and test methods defined by this international standard for "Dentistry - Polymer-based filling, restorative and luting materials."
Predicate Device Performance: The performance characteristics of the legally marketed predicate device (K063595) also serve as a comparative ground truth.

8. Sample Size for Training Set

Not applicable / Not explicitly mentioned. Material science testing typically doesn't involve "training sets" in the way machine learning algorithms do. The "training" for the device design would involve research and development to formulate the material to meet desired specifications, but no data set of this nature is described.

9. How Ground Truth for Training Set Was Established

Not applicable. See point 8. The "ground truth" for material development generally stems from established dental material science principles, clinical needs, and the performance characteristics of existing successful products (like the predicate device).

Summary

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[CLEARFIL MAJESTY Posterior, KURARAY MEDICAL INC.]

MAR - 5 2010

1400328

Dalc: February 2, 2010

510(k) Summary

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

Address
Contact person
Contact person in U.S.

KURARAY MEDICAL INC.

1621 Sakazu, Kurashiki, Okayama 710-0801, Japan

Michio Takigawa Quality Assurance Department

Kiyoyuki Arikawa KURARAY AMERICA INC. 600 Lexington Avenue, 26th Floor New York, NY 10022 Tcl: (212)-986-2230 (Ext. 115) or (800)-879-1676 Fax: (212)-867-3543

3-2. Name of Device

Trade / Proprietary name
Classification name
Common name
Device Listing number

3-3. Predicate device

CLEARFIL MAJESTY Postcrior

CLEARFIL MAJESTY Posterior Tooth shade resin material (21 CFR section 872.3690. Product code: EBF) Restorative composite resin 12001413

510(k) Number:	K063595
Classification:	Tooth shade resin material
Product Code:	EBF
21 CFR Section:	872.3690
Applicant:	KURARAY MEDICAL INC

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3-4. Device Description

All chemical ingredients of the subject device have been used in the predicate device. And the chemical composition of the subject device is very similar to that of the predicate device. Furthermore, physical and mechanical properties of the subject device were evaluated according to ISO 4049 in comparison with the predicate device, in which the similarity between the subject device and the predicate device was shown in terms of effectiveness/performance. Therefore, it was concluded that the subject device was closely similar to the predicate device.

3-5. Similarities and/or differences Discussion

1) Intended uses

The intended uses of the subject device are the same as those of the predicate device.

Direct restorations for anterior and posterior tecth (Class 1 V cavities) (1)
(2) Correction of tooth position and tooth shape (c.g. diastema closure, dwarfed tooth, etc.)
Intraoral repairs of fractured crowns/bridges (3)

2) Chemical ingredients / Safety

The chemical composition of the subject device is very similar to that of the predicate device, suggesting that the safety of the subject device is closely similar to the predicate device. Furthermore, the safety of the predicate device has been shown in the original application. Therefore, we have concluded that the subject device was biologically safe.

3) Effectiveness / Performance

It has been verified that the subject device complies with the requirements of the applicable IDA recognized consensus standard, ISO 4049: 2000 "Dentistry - Polymer-based filling, restorative and luting materials". As to comparison with the predicate device, according to ISO 4049; 2000, both the subject device and the predicate device comply with ISO 4049: 2000, indicating that the subject device is as effective as and performs as well as the predicate device.

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3-6. Biocompatibility

All chemical ingredients of the subject device are the same as those of the predicate device as described in 7-4. From this fact, it can be said that the safety of the subject device is closely similar to the predicate device. Furthermore, we have already shown the biocompatibility of the predicate device in the original application. Additionally, the predicate device has been sold for 2 years and there were no reported problems or recalls according to the post market adverse event reporting requirement. Therefore, it was concluded that the subject device was biologically safe.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

MAR ~ 5 2010

Kuraray Medical, Incorporated C/O Mr. Kiyoyuki Arikawa Kuraray America, Incorporated 600 Lexington Avenue, 26th Floor New York, New York 1002

Re: K100328

Trade/Device Name: CLEARFIL MAJESTY Posterior Regulation Number: 21CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: February 2, 2010 Received: February 8, 2010

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,

h for

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

1400328 510(k) Number (if known):

Device Name: _CLEARFIL MAJESTY Posterior

Indications for Use:

Direct restorations for anterior and posterior teeth (Class I - V cavities)

1. Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed tooth, etc.)

Intraoral repairs of fractured crowns/bridges

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use _ N/A (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

	RSBetz DDS for Dr. K.P. Mulry
	(Division Sign-Off)
	Division of Anesthesiology, General Hospital
	Infection Control, Dental Devices
510(k) Number:	K100328

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.