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

Device Description

CLEARFIL MAJESTY IC is an intra-oral, light-cured restorative composite that is available direct injection method into preparations with its syringe and replaceable tips. It is the radiopaque equivalent of 1mm aluminium and classified as a Type 1 and Class 2 (Group 1) material by ISO 4049. It is indicated for both anterior and posterior restorations and provides accurate color matching, high polishability and excellent physical properties.

AI/ML Overview

The medical device in question is CLEARFIL MAJESTY IC, a dental light-cured restorative composite. The provided document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study for novel performance claims. As such, the information you've requested about acceptance criteria and study particulars for device performance in a clinical setting is not fully available in this type of submission.

This submission primarily relies on non-clinical testing to demonstrate that the physical and mechanical properties of the subject device are substantially equivalent to those of the predicate device(s).

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" for each test item but rather states that the "Result demonstrated substantial equivalence" to the predicate device. The underlying acceptance criterion for each test would be that the subject device's performance falls within a range considered comparable to the predicate device, as defined by relevant ISO standards (specifically ISO 4049:2009 for polymer-based restorative materials) and FDA guidance for dental composite resin devices.

Test Item	Acceptance Criterion (Implicit)	Reported Device Performance
Sensitivity to ambient light	Substantially equivalent to Primary Predicate device.	The result demonstrated substantial equivalence.
Depth of cure	Substantially equivalent to Primary Predicate device.	The result demonstrated substantial equivalence.
Flexural strength	Substantially equivalent to Primary Predicate device.	The result demonstrated substantial equivalence.
Water sorption and solubility	Substantially equivalent to Primary Predicate device.	The result demonstrated substantial equivalence.
Shade, filling and restorative materials	Substantially equivalent to Primary Predicate device.	The result demonstrated substantial equivalence.
Color stability after irradiation and water sorption	Substantially equivalent to Primary Predicate device.	The result demonstrated substantial equivalence.
Radio-opacity	Substantially equivalent to Primary Predicate device.	The result demonstrated substantial equivalence.
Compressive strength	Substantially equivalent to Primary Predicate device.	The result demonstrated substantial equivalence.
Elastic modulus	Substantially equivalent to Primary Predicate device/Reference device.	The result demonstrated substantial equivalence.
Intensity for curing	Substantially equivalent to Primary Predicate device.	The result demonstrated substantial equivalence.
Wavelength for curing	Substantially equivalent to Primary Predicate device.	The result demonstrated substantial equivalence.
Filler particle size distribution	Substantially equivalent to Primary Predicate device.	The result demonstrated substantial equivalence.
Surface hardness	Substantially equivalent to Primary Predicate device.	The result demonstrated substantial equivalence.
Curing time	Substantially equivalent to Primary Predicate device.	The result demonstrated substantial equivalence.
Biocompatibility (ISO 10993-1:2009)	Substantially equivalent to Primary Predicate device/Reference device based on ingredients, indications, manufacturing process, contact part, and duration.	Substantially equivalent in biocompatibility.
Shelf Life (based on ISO 4049:2009)	Properties maintained after accelerated aging equivalent to 48 months at 2-25 °C/36-77 °F.	Determined to be 48 months at 2-25 °C/36-77 °F.

2. Sample Size Used for the Test Set and Data Provenance

The document describes non-clinical testing (e.g., material property tests) rather than a clinical test set involving human subjects. Therefore, information regarding "sample size for the test set" in a clinical context and "data provenance (e.g. country of origin of the data, retrospective or prospective)" is not applicable or provided. The tests described are laboratory-based evaluations of material properties.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable. The evaluations were non-clinical material property tests, not assessments requiring expert consensus on a test set (e.g., image interpretation). The "ground truth" for these tests would be the established scientific methods and resulting measurements according to ISO standards.

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

This information is not applicable as the study involved non-clinical material property testing, not an adjudication process for expert opinions.

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. The device is a dental restorative material, not an AI-assisted diagnostic or therapeutic device. No MRMC study or AI assistance is mentioned or relevant to this 510(k) submission.

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

This information is not applicable as the device is a dental restorative material, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is based on established scientific and engineering standards and methodologies, specifically:

ISO 4049: 2009 (Dentistry - Polymer-based restorative and materials) for physical and mechanical properties.
"Dental Composite Resin Devices – Premarket Notification [510(k)] Submissions – Guidance for Industry and FDA Staff" for additional physical properties.
ISO 10993-1:2009 for biological evaluation (biocompatibility).

Performance is compared against the predicate device's performance under these established methods.

8. The Sample Size for the Training Set

This information is not applicable. This is not a machine learning device, so there is no concept of a "training set."

9. How the Ground Truth for the Training Set was Established

This information is not applicable. There is no training set for this device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 3, 2019

Kuraray Noritake Dental Inc. Yasujiro Ohara Manager Ote Center Bldg. 7F, 1-1-3, Otemachi Chiyoda-ku, Tokyo 100-0004 JAPAN

Re: K182430

Trade/Device Name: CLEARFIL MAJESTY IC Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: January 31, 2019 Received: February 4, 2019

Dear Yasujiro Ohara:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

{1}------------------------------------------------

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Malvina Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known): K182430

Device Name: CLEARFIL MAJESTY IC

Indications for Use:

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

[2] Direct veneers

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

[4] Intraoral repairs of fractured restorations

Prescription Use _____________________________________________________________________________________________________________________________________________________________ Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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)

{3}------------------------------------------------

510(k) Summary

Kuraray Noritake Dental Inc.

CLEARFIL MAJESTY IC

Dental light-cured restorative composite

21 CFR 872.3690

EBF

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

1. Name
1. Address
1. Contact person

Contact person in US

1621 Sakazu, Kurashiki, Okayama 710-0801, Japan Yasujiro Ohara Quality Assurance Department Manabu Suzuki KURARAY AMERICA, INC. 33 Maiden Lane, 6th Floor, New York, NY 10038 Tel: (212)-986-2230 (Ext. 115) or (800)-879-1676 Fax: (212)-867-3543

3-2. Name of Device

1. Trade / Proprietary Name:
1. Regulation Number:
1. Product Code:
1. Common Name

3-3. Primary Predicate Device

CLEARFIL MAJESTY ES-2	510(k) Number:Classification:Product Code:21 CFR:Applicant:	K121583Tooth shade resin materialEBF872.3690Kuraray Noritake Dental Inc.
CLEARFIL MAJESTY ES Flow	510(k) Number:Classification:Product Code:21 CFR:Applicant:	K130371Tooth shade resin materialEBF872.3690Kuraray Noritake Dental Inc.
ESTENIA C&B	510(k) Number:Classification:Product Code:21 CFR:Applicant:	K042929Tooth shade resin materialEBF872.3690Kuraray Noritake Dental Inc.
Filtek One Bulk Fill Restorative	510(k) Number:Classification:Product Code:21 CFR:Applicant:	K163207Tooth shade resin materialEBF872.36903M Company
CLEARFIL MAJESTY Posterior PLT	510(k) Number:Classification:Product Code:21 CFR:Applicant:	K092281Tooth shade resin materialEBF872.3690

{4}------------------------------------------------

	Applicant:	Kuraray Noritake Dental Inc.
EPRICORD	510(k) Number:	K033267
	Classification:	Tooth shade resin material
	Product Code:	EBF
	21 CFR:	872.3690
	Applicant:	Kuraray Noritake Dental Inc.

3-4. Device Description

3-5. Indications for Use Statement

The subject device is indicated for the following uses:

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

3-6. Substantial Equivalence Discussion

1) Indications for Use

The Indications for Use of the subject device is identical to the primary predicate device. Therefore, the Indications for Use of the subject device is substantially equivalent to that of the primary predicate device.

The indications of the subject device and the primary predicate device are as listed on the following table.

	Subject device	Primary predicate device
Trade name	CLEARFIL MAJESTY IC	CLEARFIL MAJESTY ES-2
Indicationsfor Use	[1] Direct restorations for all cavity classes inanterior and posterior teeth[2] Direct veneers[3] Correction of tooth position and tooth shape(e.g. diastema closure, dwarfed tooth, etc.)[4] Intraoral repairs of fractured restorations	[1] Direct restorations for all cavity classes inanterior and posterior teeth[2] Direct veneers[3] Correction of tooth position and tooth shape(e.g. diastema closure, dwarfed tooth, etc.)[4] Intraoral repairs of fractured restorations

Table 3-6. Indications for Use of the subject device and the primary predicate device

2) Chemical ingredients

All ingredients in the subject device and its accessories have been used in the primary predicate device and the reference devices.

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

The chemical ingredients of the subject device and its accessories are equivalent to those of the primary predicate device and the reference devices.

{5}------------------------------------------------

Technological characteristics/ Non-Clinical Testing

< Technological characteristics >
Physical and mechanical properties of the subject device were evaluated according to ISO 4049: 2009 (Dentistry - Polymer-based restorative and 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.

In addition, we examined the subject device concerning the Physical Properties described in the "Dental Composite Resin Devices – Premarket Notification [510(k)] Submissions – Guidance for Industry and FDA Staff".

Therefore, we considered sensitivity to ambient light, Depth of cure, flexural strength, water sorption and solubility, shade, filling and restorative materials, color stability after irradiation and water sorption, radio-opacity, compressive strength, elastic modulus, intensity for curing, wavelength for curing, filler particle size distribution, surface hardness and curing time as physical properties when testing the subject device. The subject device doesn't contain chemical ingredients which are corresponded releasable agents "such as fluoride or nitrate ions". The compared test items and the evaluation results are described as follows.

{6}------------------------------------------------

Test item	For comparison:Primary Predicate deviceorReference device	Result
Sensitivity to ambient light	Primary Predicate device	The result demonstrated substantial equivalence.
Depth of cure	Primary Predicate device	The result demonstrated substantial equivalence.
Flexural strength	Primary Predicate device	The result demonstrated substantial equivalence.
Water sorption and solubility	Primary Predicate device	The result demonstrated substantial equivalence.
Shade, filling and restorative materials	Primary Predicate device	The result demonstrated substantial equivalence.
Color stability afterirradiation and watersorption	Primary Predicate device	The result demonstrated substantial equivalence.
Radio-opacity	Primary Predicate device	The result demonstrated substantial equivalence.
Compressive strength	Primary Predicate device	The result demonstrated substantial equivalence.
Elastic modulus	Primary Predicate deviceReference device	The result demonstrated substantial equivalence.
Intensity for curing	Primary Predicate device	The result demonstrated substantial equivalence.
Wavelength for curing	Primary Predicate device	The result demonstrated substantial equivalence.
Filler particle sizedistribution	Primary Predicate device	The result demonstrated substantial equivalence.
Surface hardness	Primary Predicate device	The result demonstrated substantial equivalence.
Curing time	Primary Predicate device	The result demonstrated substantial equivalence.

So we conducted the comparative tests for above test items. And all of tests results demonstrated that each characteristic of the subject device is substantially equivalent to that of the primary predicate device or the reference devices.

{7}------------------------------------------------

< Non-Clinical Testing >

The subject device is categorized into the external communicating device (dentin) and permanent contact device.

All the chemical ingredients of the subject device are equivalent to those of the primary predicate device and the reference devices.

Contacting information about the accessories of the subject device is as follows;

Item	Human contacting information	The reference device
Syringe	Indirect	CLEARFIL MAJESTY ES Flow
Dispensing tip	Direct	510(k) Number; K130371
Dispensing tip cap	Indirect	CLEARFIL MAJESTY Posterior PLT510(k) Number; K092281

All the chemical ingredients of accessories about the subject device are equivalent to those of the reference device.

And biological evaluation was conducted according to ISO10993-1:2009.

Concerning the track records of the ingredients, Indications for Use, manufacturing process, contact part and contact duration, all of these are substantially equivalent to those of the primary predicate device and the reference devices.

Therefore, the subject device and its accessories are substantially equivalent in biocompatibility to the primary predicate device and the reference devices.

Concerning Shelf Life, the subject device was evaluated by using temperature accelerated samples. And the properties of them which are equivalent to storing at 25°C/ 77 °F more than 48 months were complied with ISO 4049: 2009. So the Shelf Life of the subject device was determined to be 48 months at 2-25 °C/ 36-77 °F.

3-7. Conclusion

The comparison for Indications for Use, chemical ingredients and performance data shows that the subject device is substantially equivalent to the primary predicate device and the reference devices.

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.