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 PLT (PLT:Pre-loaded tip) 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 easy handling and placement. CLEARFIL MAJESTY Posterior PLT, with its special dispensing system, can be quickly and conveniently placed directly into the cavity.
In this application, we have precisely defined the amount of dl-Camphorquinone and N.N-Diethanol-p-toluidine (DEPT) contained in CLEARFIL MAJESTY Posterior PLT in range of chemical composition shown in the original application in order to improve its sensitivity to ambient light.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental restorative material, CLEARFIL MAJESTY Posterior PLT. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical studies with new acceptance criteria and performance evaluations for the subject device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not present in this document.

The document primarily relies on:

Comparison of Chemical Composition: The subject device has precisely defined amounts of dl-Camphorquinone and N,N-Diethanol-p-toluidine (DEPT) within the range of the predicate device.
Compliance with Standards: The subject device, like the predicate, complies with ISO 4049:2000 "Dentistry - Polymer-based filling, restorative and luting materials" for physical and mechanical properties.
Similarity of Intended Use: The intended uses are identical to the predicate device.
Biocompatibility by Reference: All chemical ingredients are the same as the predicate and its safety has been previously established and confirmed by the predicate device being on the market for 2 years with no reported problems or recalls.

In lieu of a table of acceptance criteria and reported device performance, the document states:

"Furthermore, physical and mechanical properties of the subject device were evaluated according to ISO 4049 in comparison with the predicate device, in which the substantial equivalence between the subject device and the predicate device was shown in terms of effectiveness/performance."

And, "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."

Summary of available information:

A table of acceptance criteria and the reported device performance: Not explicitly stated as acceptance criteria in the context of a new efficacy study. The device's performance is demonstrated by its compliance with ISO 4049:2000, which is also met by the predicate device.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for this type of submission. Performance was shown through compliance with an international standard.
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): Not applicable.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 diagnostic or assistance tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. Compliance with an engineering standard (ISO 4049:2000) was used to demonstrate performance.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary

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K092281

July 24, 2009 Date:

510(k) Summary

OCT & 7 2009

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

Address

3-2. Name of Device

Contact person
Contact person in U.S.
Trade / Proprietary name
Classification name
Device Listing number
Common name

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 Tel: (212)-986-2230 (Ext. 115) or (800)-879-1676 Fax: (212)-867-3543

CLEARFIL MAJESTY Posterior PLT Tooth shade resin material (21 CFR section 872.3690. Product code: EBF) Restorative composite resin R001413

3-3. Predicate device 1) CLEARFIL MAJESTY Posterior PLT

K071169 510(k) Number: Tooth shade resin material Classification: Product Code: EBF 872.3690 21 CFR Section: KURARAY MEDICAL INC. Applicant:

Quality Assurance Department Ote Center Bldg. 7F, 1-1-3 Otemachi, Chiyoda-ku, Tokyo, 100-0004, Japan Tel : +81.(0)3.6701.1706 Fax : +81.(0)3.6701.1805

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3-4. Device Description

In this application, we have precisely defined the amount of dl-Camphorquinone and N.N-Diethanol-p-toluidine (DEPT) contained in CLEARFIL MAJESTY Posterior PLT in range of chemical composition shown in the original application in order to improve its sensitivity to ambient light. Each of the detailed description is as follows.

Chemical ingredient	(weight %)
	Predicate device	Subject device
dl-Camphorquinone	not more than 0.1	0.02
N,N-Diethanol-p-toluidine(DEPT)	not more than 0.1	0.10

All chemical ingredients of the subject device have been used in the predicate device. And 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 substantial equivalence between the subject device and the predicate device was shown in terms of effectiveness/performance. Therefore, it was concluded that the subject device was substantially equivalent to the predicate device.

3-5. Substantial Equivalence 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 teeth (Class I V cavities) (1)
Correction of tooth position and tooth shape (e.g. diastema closure, dwarfed (2) tooth, etc.)
Intraoral repairs of fractured crowns/bridges (3)
1. 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 substantially equivalent to the predicate device. Furthermore, the safety of the predicate device has been shown in the original application. Therefore, it was 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 FDA 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 An enembed in 7-4. From this fact, it can be said that the safety of the subject device is substantially equivalent 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 seal of the Department of Health & Human Services (HHS). The seal features a stylized image of an eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Kuraray Medical, Incorporated C/O Mr. Kiyoyuki Arikawa Kuraray America, Incorporated 600 Lexington Avenue, 26th Floor New York, New York 10022

OCT 2 7 2009

Re: K092281

Trade/Device Name: CLEARFIL MAJESTY Posterior PLT Regulation Number: 21CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: July 24, 2009 Received: August 4, 2009

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.

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 (CDRII'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.

for
Susan Peterson, D.D.S., M.A.

Susan Runner, D.D.S., Acting 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): KO92281

Device Name: _CLEARFIL MAJESTY Posterior PLT

Indications for Use:

1. 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.)
1. 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)

	Kevin Mulvy for MSR
Division Sign-Off)

Division of Anesthesiology, General Hospital
Infection Control, Dental Devices

510(k) Number:	K092281
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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.