Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the chemical and physical properties of a dental bonding agent and etching gel, with no mention of AI or ML.

Therapeutic

No
The device is a bonding agent used for dental restorations and treatments, which are considered mechanical or structural interventions rather than therapeutic treatments aimed at curing or preventing disease.

Diagnostic

No

Explanation: The device description and intended use indicate that this product is a bonding agent and etching gel used for dental restorations and treatments, not for identifying or diagnosing a condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components (BOND, K-ETCHANT Syringe) and chemical compositions (light-cure bonding agent, phosphoric acid aqueous solution, colloidal silica), indicating it is a physical medical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use/Indications for Use: The listed uses are all related to dental procedures performed directly on a patient's teeth and surrounding structures (restorations, sealing, treating surfaces, cementation). These are therapeutic and restorative actions, not diagnostic tests performed on samples taken from the body.
Device Description: The description details a bonding agent and etching gel used in dental procedures. It describes how it interacts with dental materials and tooth structure, not how it analyzes biological samples.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
Performance Studies and Metrics: The performance studies and metrics (bond strength, depth of cure, pH) are all related to the physical and chemical properties of the dental material and its interaction with tooth structure, not diagnostic accuracy or performance on biological samples.

In summary, the device is a dental material used for direct and indirect restorations and related procedures, which falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

[1] Direct restorations using light-cured composite resin
[2] Sealing of a prepared cavity or abutment tooth as a pretreatment for indirect restorations
[3] Treatment of exposed root surfaces
[4] Treatment of hypersensitive teeth
[5] Intraoral repairs of fractured restorations
[6] Post cementation and core build-ups
[7] Cementation of indirect restorations

Product codes

KLE

Device Description

CLEARFIL Universal Bond Quick 2 consists of BOND and K-ETCHANT Syringe. BOND is a light-cure bonding agent that allows for the treatment of dentin, enamel, and prosthetic materials. Depending on the indication, BOND is used as self-etching or with K-ETCHANT Syringe for selective enamel etching or total-etching procedures. BOND is intended to be used for both direct and indirect restorations. CLEARFIL DC Activator activates the dual-curing mechanism of BOND; however, the addition of CLEARFIL DC Activator to the adhesive is not required when using BOND with CLEARFIL DC CORE PLUS, self-adhesive resin cements manufactured by Kuraray Noritake Dental Inc. (Kuraray's self-adhesive cements, e.g. PANAVIA SA Cement Universal) or PANAVIA Veneer LC. K-ETCHANT Syringe is an etching gel that consists of 35 % phosphoric acid aqueous solution and colloidal silica.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Since there have not been any international standards concerning performance of this type of device, certain tests were performed on this device, in comparison with the primary predicate device and it was confirmed that this device was substantially equivalent to the primary predicate device in terms of the effectiveness and performance.

Shear/tensile bond strength and Fluoride release testing were performed to validate the substantial equivalence of the subject device with the primary predicate device in terms of safety and effectiveness. The test has met all the criteria indicating that the subject device was as effective as the primary predicate device.

Performance tests showed:

Depth of cure: Equal to or greater than 0.5 mm - COMPLIES
Shear bond strength to bovine enamel: Equal to or greater than 10 MPa - COMPLIES
Shear bond strength to bovine dentin: Equal to or greater than 10 MPa - COMPLIES
Tensile bond strength to dental ceramic: Equal to or greater than 10 MPa - COMPLIES
Tensile bond strength to metal: Equal to or greater than 17 MPa - COMPLIES
Occlusion dentinal tubules: Dentinal tubules are occluded - COMPLIES
pH: 2.4 ± 0.4 - COMPLIES

The results indicate that the subject device and the primary predicate device comply with the requirements of the in-house standard. From the above, it can be said that comparative study of the subject device is substantially equivalent to that of the primary predicate device. It also can be said that shear bond strength to bovine enamel/dentin of the subject device is substantially equivalent to that of the predicate device.

Fluoride release testing was performed to validate the substantial equivalence of the subject device with the primary predicate device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K161042, K213965

Reference Device(s)

K042929

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 872.3200 Resin tooth bonding agent.

(a)
Identification. A resin tooth bonding agent is a device material, such as methylmethacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.(b)
Classification. Class II.

Summary

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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 & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 13, 2023

Kuraray Noritake Dental Inc. Yasujiro Ohara General Manager Tokiwabashi Tower, 2-6-4, Otemachi Chiyoda-ku, Tokyo 100-0004 JAPAN

Re: K231039

Trade/Device Name: CLEARFIL Universal Bond Quick 2 Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: November 13, 2023 Received: November 13, 2023

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 (the 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 available 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

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

2

Sincerely,

Michael E. Adjodha -S

Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

CLEARFIL Universal Bond Quick 2

Indications for Use (Describe)

[1] Direct restorations using light-cured composite resin
[2] Sealing of a prepared cavity or abutment tooth as a pretreatment for indirect restorations

[3] Treatment of exposed root surfaces

[4] Treatment of hypersensitive teeth

[5] Intraoral repairs of fractured restorations

[6] Post cementation and core build-ups

[7] Cementation of indirect restorations

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Date: 11th December, 2023

510(k) Summary

5-1. 510(k) owner (submitter)

1) Name	Kuraray Noritake Dental Inc.
2) Address	1621 Sakazu, Kurashiki, Okayama 710-0801, Japan
3) Contact person	Yasujiro Ohara
General Manager
Quality Assurance Department
4) Contact person in US	Manabu Suzuki
Director
Dental Material Division
KURARAY AMERICA, INC.
32 Old Slip, 7th Floor, New York, NY 10005
Tel: (212)-356-3940 (Ext. 115) or (800)-879-1676
Fax: (888)-700-5200
5-2. Name of Device
1) Trade / Proprietary name	CLEARFIL Universal Bond Quick 2
2) Classification name	Agent, Tooth Bonding, Resin
(21 CFR section: 872.3200. Product code: KLE)
3) Common name	Dental Bonding agent

5

5-3. Predicate devices
1) CLEARFIL Universal Bond Quick	510(k) Number	K161042
(Primary predicate device)	Classification:	Agent, Tooth Bonding, Resin
	Product Code:	KLE
	21 CFR Section:	872.3200
	Applicant:	Kuraray Noritake Dental Inc.
2) BeautiBond Xtreme	510(k) Number	K213965
(Predicate device)	Classification:	Agent, Tooth bonding, Resin
	Product Code:	KLE
	21 CFR Section:	872.3200
	Applicant:	Shofu Dental Corporation
3) ESTENIA C&B	510(k) Number	K042929
(Reference device)	Classification:	Material, Tooth shade, Resin
	Product Code:	EBF
	21 CFR Section:	872.3690
	Applicant:	Kuraray Noritake Dental Inc.

5-4. Device Description

CLEARFIL Universal Bond Quick 2 consists of BOND and K-ETCHANT Syringe. BOND is a light-cure bonding agent that allows for the treatment of dentin, enamel, and prosthetic materials. Depending on the indication, BOND is used as self-etching or with K-ETCHANT Syringe for selective enamel etching or total-etching procedures. BOND is intended to be used for both direct and indirect restorations. CLEARFIL DC Activator activates the dual-curing mechanism of BOND; however, the addition of CLEARFIL DC Activator to the adhesive is not required when using BOND with CLEARFIL DC CORE PLUS, self-adhesive resin cements manufactured by Kuraray Noritake Dental Inc. (Kuraray's self-adhesive cements, e.g. PANAVIA SA Cement Universal) or PANAVIA Veneer LC. K-ETCHANT Syringe is an etching gel that consists of 35 % phosphoric acid aqueous solution and colloidal silica.

This is the new registration application for the subject device and there have not been any prior submissions regarding the subject device.

We are seeking clearance for CLEARFIL Universal Bond Quick 2 BOND in this permission. Concerning K-ETCHANT Syringe which is included as components of CLEARFIL Universal Bond Quick 2, the specification of the component was omitted since we already have had 510(k) clearance of K-ETCHANT Syringe (510(k) Number: 133078).

5-5. Statement of Intended Use

The subject device is indicated for the following uses:

[1] Direct restorations using light-cured composite resin

[2] Sealing of a prepared cavity or abutment tooth as a pretreatment for indirect restorations
[3] Treatment of exposed root surfaces
[4] Treatment of hypersensitive teeth
[5] Intraoral repairs of fractured restorations
[6] Post cementation and core build-ups
[7] Cementation of indirect restorations

6

5-6. Substantial Equivalence Discussion

1) Intended uses

The intended use of the subject device and the predicate devices are listed on the following table.

	Trade name	Intended use
Subject
device	CLEARFIL
Universal Bond
Quick 2	[1] Direct restorations using light-cured composite resin
[2] Sealing of a prepared cavity or abutment tooth as a pretreatment for indirect restorations
[3] Treatment of exposed root surfaces
[4] Treatment of hypersensitive teeth
[5] Intraoral repairs of fractured restorations
[6] Post cementation and core build-ups
[7] Cementation of indirect restorations
Primary
predicate
device	CLEARFIL
Universal Bond
Quick	[1] Direct restorations using light-cured composite resin
[2] Cavity sealing as a pretreatment for indirect restorations
[3] Treatment of exposed root surfaces
[4] Treatment of hypersensitive teeth
[5] Intraoral repairs of fractured restorations
[6] Post cementation and core build-ups
[7] Cementation of indirect restorations
Predicate
device	BeautiBond
Xtreme	[1] Direct restorations with light-cured composite resin
[2] Repair of fractured restorations with light-cured composite resin
[3] Post cementation and core build-up
[4] Cementation of indirect restorations with light-cured/dual-cured resin cement
[5] Treatment of hypersensitive teeth or exposed root surface
[6] Sealing of tooth preparation (cavity or abutment) for indirect restorations

The intended use of the subject device is substantially equivalent to that of CLEARFIL Universal Bond Quick (Primary predicate device) or BeautiBond Xtreme (Predicate device).

Therefore, the intended use of the subject device is substantially equivalent to that of the predicate devices.

1. Chemical ingredients/ Safety
  All ingredients have been used in the primary predicate device or the reference device as described in "Section 12: Substantial Equivalence Discussion". Regarding these primary predicate device and reference device, there have not been any reported problems or recalls according to the post market adverse event reporting requirements in the US.

We evaluated the subject device referring to Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" Guidance for Industry and Food and Drug Administration Staff", ISO 10993 series and ISO 7405. As a result of the evaluation, it was concluded that the subject device is substantially equivalent in biological safety to the primary predicate device and the reference device.

1. Comparison of Technological characteristics/ Effectiveness and Performance
  Since there have not been any international standards concerning performance of this type of device, certain tests were performed on this device, in comparison with the primary predicate device and it was confirmed that this device was substantially equivalent to the primary predicate device in terms of the effectiveness and performance.

Shear/tensile bond strength and Fluoride release testing were performed to validate the substantial equivalence of the subject device with the primary predicate device in terms of safety and effectiveness. The test has met all the criteria indicating that the subject device was as effective as the primary predicate device.

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| Section | Requirement | CLEARFIL
Universal Bond
Quick 2
(Subject device) | CLEARFIL
Universal Bond
Quick
(Primary predicate
device) | BeautiBond
Xtreme
(Predicate device) |
|--------------------------------------------|---------------------------------------------------------------|-----------------------------------------------------------|----------------------------------------------------------------------|--------------------------------------------|
| Appearance | Yellow or orange transparent liquid
No extraneous material | COMPLIES | COMPLIES | |
| Easy of application | Easy to apply | COMPLIES | COMPLIES | |
| Depth of cure | Equal to or greater than 0.5 mm | COMPLIES | COMPLIES | |
| Shear bond strength to
bovine enamel | Equal to or greater than 10 MPa | COMPLIES | COMPLIES | COMPLIES |
| Shear bond strength to
bovine dentin | Equal to or greater than 10 MPa | COMPLIES | COMPLIES | COMPLIES |
| Tensile bond strength to
dental ceramic | Equal to or greater than 10 MPa | COMPLIES | COMPLIES | |
| Tensile bond strength to
metal | Equal to or greater than 17 MPa | COMPLIES | COMPLIES | |
| Occlusion dentinal
tubules | Dentinal tubules are occluded | COMPLIES | COMPLIES | |
| pH | 2.4 ± 0.4 | COMPLIES | COMPLIES | |

The results of comparative study performed were indicated below.

The results indicate that the subject device and the primary predicate device comply with the requirements of the in-house standard. From the above, it can be said that comparative study of the subject device is substantially equivalent to that of the primary predicate device. It also can be said that shear bond strength to bovine enamel/dentin of the subject device is substantially equivalent to that of the predicate device.

Fluoride release testing was performed to validate the substantial equivalence of the subject device with the primary predicate device.

It was concluded that the subject device is substantially equivalent to the primary predicate device.

5-7. Biocompatibility

The subject device is categorized into the external communicating device (tissue/ bone/dentin) and permanent contact device. There is no new ingredient in the subject device. K-ETCHANT Syringe is categorized into the external communicating device that may contact dentin and whose duration of contact is less than 24 hours.

All ingredients in the subject device have been used in the primary predicate device and the reference device as described in "Section 12: Substantial Equivalence Discussion". Regarding these primary predicate device and reference device, there have not been any reported problems or recalls according to the post market adverse event reporting requirements in the US. Moreover, we already have had 510(k) clearance of K-ETCHANT Syringe (510(k) Number: K133078).

Accordingly, it was considered that the subject device was substantially equivalent in biocompatibility to the primary predicate device and the reference device.

5-8. Conclusion

The comparison for intended uses, chemical ingredients/ safety and performance data shows that the subject device is substantially equivalent to the predicate devices and the reference device. This submission information including the nonclinical testing provided supports that the subject device is as safe and as effective as the primary predicate device.