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.

CLEARFIL MAJESTY Posterior PLT, the applicant device, is substantially the same as CLEARFIL MAJESTY Posterior, the predicate device where the only difference is the container form; the applicant device comes in tips while the predicate device is filled in syringes. The tips used in the applicant device are the same as those used in CLEARFIL AP-X PLT, the predicate device, except for the color. The applicant device is substantially equivalent to the predicate devices.

AI/ML Overview

This document is a 510(k) premarket notification for a dental restorative material, not a software or AI-powered device. Therefore, many of the requested elements for an AI/software device study are not applicable or present in this submission.

Based on the provided text, here's a breakdown of the acceptance criteria and the "study" (validation) for the device:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Intended Uses (Functionality)	The device (CLEARFIL MAJESTY Posterior PLT) is intended for:
1) Direct restorations for anterior and posterior teeth (Class I - V cavities)	Implicitly met by substantial equivalence claim to predicate devices with these indications.
2) Correction of tooth position and tooth shape (e.g., diastema closure, dwarfed tooth, etc.)	Implicitly met by substantial equivalence claim to predicate devices with these indications.
3) Intraoral repairs of fractured crowns/bridges	Implicitly met by substantial equivalence claim to predicate devices with these indications.
Chemical Composition / Safety	All chemical compositions are exactly the same as the predicate device (CLEARFIL MAJESTY Posterior), suggesting substantial equivalence in safety.
Effectiveness / Performance (Physical Properties)	Complies with the requirements of ISO 4049:2000 "Dentistry - Polymer-based filling, restorative and luting materials." Both the applicant device and the predicate device (CLEARFIL MAJESTY Posterior) comply with this standard, indicating the applicant device is as effective and performs as well.
Biocompatibility	All chemical compositions have been used in the predicate devices, indicating substantial equivalence in biocompatibility.
Substantial Equivalence (Overall comparison to predicate devices)	The device is deemed "substantially equivalent" to predicate devices (CLEARFIL MAJESTY Posterior and CLEARFIL AP-X PLT). The only difference is the container form (pre-loaded tips vs. syringes), and the tips themselves are the same as another predicate (CLEARFIL AP-X PLT) except for color.

Study Information (as applicable to this type of device submission):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This document does not describe a clinical study of the device that would involve a "test set" in the context of an AI/software device. The validation is primarily based on bench testing against an international standard (ISO 4049:2000) and a comparison of chemical compositions and intended uses to existing predicate devices.
- No specific sample sizes for physical property testing (as would be done for ISO 4049) are provided in this summary.
- No information on data provenance for testing is provided, beyond the standard itself being international.
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 this device, is adherence to a recognized international standard for dental materials and chemical composition.
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 is not an AI or imaging device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for demonstrating substantial equivalence is:
  - Compliance with ISO 4049:2000 for physical properties.
  - Identical chemical composition to a predicate device.
  - Similar intended uses to predicate devices.
  - Prior safe use of the chemical components in other legally marketed devices.
The sample size for the training set:
- Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.

Key Takeaways from the 510(k) Summary:

The manufacturer is seeking Substantial Equivalence for a new form factor (pre-loaded tips) of an existing dental restorative material. The core of their argument is:

Chemical Identity: The new device has the exact same chemical composition as a previously cleared predicate device (CLEARFIL MAJESTY Posterior).
Performance Standard Compliance: Both the new device and a predicate device meet the requirements of the international standard ISO 4049:2000 for dental polymer-based restorative materials.
Use of Previous Components: The pre-loaded tips themselves are adopted from another existing predicate device (CLEARFIL AP-X PLT), with only a color change.
Identical Intended Uses: The indications for use are equivalent to the predicate devices.

This type of 510(k) relies heavily on demonstrating that the new device is fundamentally the same as a legally marketed predicate device, rather than requiring extensive new clinical trials or complex AI model validation.

Summary

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SCHEMATIC SUMMARY

K071169

Date: April 27, 2007

510(k) Summary

JUN 2 0 2007

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

1. Name

Address
Contact person
Contact person in U.S.

KURARAY MEDICAL INC. 1621 Sakazu, Kurashiki, Okayama 710-0801, Japan

Michio Takigawa Quality Assurance Department

CLEARFIL MAJESTY Posterior PLT

(21 CFR section 872.3690. Product code: EBF)

Tooth shade resin material

Restorative composite resin

R001413

Applicant:

510(k) Number:

Classification:

Product Code:

Applicant:

21 CFR Section:

Koji Nishida 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

3-2. Name of Device

1. Trade / Proprietary name
1. Classification name

Common name
Device listing number

3-3. Predicate device

CLEARFIL MAJESTY Posterior
CLEARFIL AP-X PLT

510(k) Number: K063595 Classification: Tooth shade resin material Product Code: EBF 21 CFR Section:

872.3690 KURARAY MEDICAL INC.

K023002 Tooth shade resin material EBF 872.3690 KURARAY MEDICAL INC.

3-4. Device Description

Quality Assurance Department

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3-5. Substantial Equivalence Discussion

1) Intended uses

It is intended to be used for the indications listed in the left hand column of the below table that are equivalent to the predicate devices.

Table 3: Indications for Use and predicate devices

Indications for Use	Predicate devices
1) Direct restorations for anterior and posteriorteeth (Class I - V cavities)	CLEARFIL MAJESTY Posterior,CLEARFIL AP-X PLT
2) Correction of tooth position and tooth shape(e.g. diastema closure, dwarfed tooth, etc.)	CLEARFIL MAJESTY Posterior
3) Intraoral repairs of fractured crowns/bridges	CLEARFIL MAJESTY Posterior

2) Chemical composition / Safety

All the chemical composition of CLEARFIL MAJESTY Posterior PLT, the applicant device, are exactly the same as those in CLEARFIL MAJESTY Posterior, the predicate device
suggesting the safety of the applicant device is substantially equivalent to the predicat device.

3) Effectiveness / Performance

CLEARFIL MAJESTY Posterior PLT, the applicant device, is verified to comply with the requirements of the applicable FDA recognized consensus standard, ISO 4049: 2000 "Dentistry - Polymer-based filling, restorative and luting materials". As to compare with CLEARFIL MAJESTY Posterior, the predicate device, according to ISO 4049: 2000, both the applicant and the predicate devices comply with ISO 4049: 2000 indicating that the applicant device is as effective as and performs as well as the predicate device.

3-6. Biocompatibility

All the chemical compositions of CLEARFIL MAJESTY Posterior PLT, the applicant device, have been used in the predicate devices as shown in the table of "Section 7: Substantial Equivalence Discussion, Table: 7-2" where all the chemical compositions of the applicant device are listed in the left hand column and the predicate devices containing the composition are listed in the right hand. From that table, it can be said that the safety of the applicant device is substantially equivalent to the predicate devices.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged in a circle around the eagle. The eagle is facing to the right. The image is in black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JUN 2 0 2007

Re: K071169

Trade/Device Name: CLEARFIL MAJESTY™ Posterior PLT Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: April 27, 2007 Received: May 03, 2007

Dear Mr. Nishida:

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. Koji Nishida

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 (Sections 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" (21 CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Clus
Shia-S. Liu, Ph.D.

Chiu S. Lin, PhD 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): L07116

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.)

Intraoral repairs of fractured crowns/bridges

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

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

N/A

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

R. Betz DDS for Dr. Susan Renner

v. General Hos

19(k) Number

2-1

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.