All classes of fillings (according to Black) with light-curing composite or compomer filling materials
Repair of composite resin or compomer fillings
Intraoral repair of composite restorations, porcelain fused to metal, and all-ceramic restorations without extra primer
Protective varnish for glass ionomer fillings

Device Description

EZ Bond Universal, manufactured by Meta Biomed, is classified as a Resin tooth bonding agent (21 C.F.R. §872.3200). EZ Bond universal is a single-bottle solution. Depending on the indication, the adhesive can be used for direct and indirect restorations with light cured composites in a "self-etching" procedure, "total-etching" procedure or" selective-etching" procedure. EZ Bond Universal is methacrylate-based restoratives, cement and sealant materials to dentin, enamel, glass ionomer and various indirect restorative substrates (glass ceramics, alumina and zirconia) without an extra primer step.

AI/ML Overview

The provided text describes the regulatory clearance of a dental bonding agent and includes a section on non-clinical testing. However, it does not contain information about a study involving AI assistance, human readers, or image analysis, which the requested questions (2-9 and parts of 1) are primarily focused on. The device is a "Resin Tooth Bonding Agent," not a device that involves AI algorithms or image interpretation by experts.

Therefore, I can only address the acceptance criteria and performance data available for this specific type of dental product based on the provided document.

Acceptance Criteria and Reported Device Performance

1. A table of acceptance criteria and the reported device performance

The document provides the reported performance values for the subject device and the predicate device against certain technical characteristics. It states that the subject device was tested to evaluate its safety and effectiveness according to ISO standards. While specific numerical acceptance criteria (e.g., "must be > X MPa") are not explicitly listed in a separate column, the values are compared to the predicate device and implicitly against relevant ISO standards.

Characteristic	Acceptance Criteria (Implicit from ISO/Predicate)	Reported Subject Device Performance	Reported Predicate Device Performance (for comparison)
Biocompatibility	Compliant with ISO 10993 series	Achieved compliance	(Not explicitly stated for predicate, assumed compliant as legally marketed)
Film thickness	Within acceptable range (ISO 4049:2019)	4 µm	10.6 µm
Sensitivity to Ambient Light	Material remains physically homogeneous	Material remained physically homogeneous	Material remained physically homogeneous
Bond strength (Dentine)	Within acceptable range (ISO 29022:2013, ISO/TC 11405:2015)	23.2 Mpa	35.8 Mpa
Bond strength (Enamel)	Within acceptable range (ISO 29022:2013, ISO/TC 11405:2015)	23.7 Mpa	26.4 Mpa
Solubility	Within the range of ISO 4049:2009	(Explicitly stated as "within the range")	(Not explicitly stated, assumed compliant)
Shelf Life	2 Years (as per predicate and ISO standards)	2 Years	2 Years

Regarding the other requested information (2-9):

The provided text does not contain any information related to:

2. Sample size used for the test set and data provenance: No information on sample sizes for the performance tests (e.g., number of dentin/enamel samples). No geographical or temporal provenance for the test data.
3. Number of experts used to establish the ground truth and their qualifications: Not applicable for this type of product/testing. Ground truth is based on physical material properties and ISO standard tests, not expert consensus on interpretations.
4. Adjudication method for the test set: Not applicable for this type of product/testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and effect size: This type of study involves human readers interpreting cases, often with AI assistance. This is not relevant to a dental bonding agent.
6. If a standalone (algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.
7. The type of ground truth used: The ground truth for this device's performance is based on physical and chemical property measurements conducted according to established international standards (ISO), not expert consensus, pathology, or outcomes data in the context of interpretation.
8. The sample size for the training set: Not applicable; this device does not use machine learning or AI with training sets.
9. How the ground truth for the training set was established: Not applicable; this device does not use machine learning or AI.

In summary, the document details non-clinical testing for a dental bonding agent, focusing on physical and chemical performance characteristics against ISO standards and comparison to a predicate device. It does not involve any imaging, AI, or human interpretation studies.

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 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.

March 3, 2023

Meta Biomed Co., LTD. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620

Re: K230009

Trade/Device Name: EZ Bond Universal Regulation Number: 21 CFR 872.3200 Regulation Name: Resin Tooth Bonding Agent Regulatory Class: Class II Product Code: KLE Dated: January 3, 2023 Received: January 3, 2023

Dear April Lee:

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.

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

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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/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 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 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).

Sincerely,

Michael E. Adjodha -S

Michael E. Adjodha, M.ChE. 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) K230009

Device Name EZ Bond Universal

Indications for Use (Describe)

· All classes of fillings (according to Black) with light-curing composite or compomer filling materials
· Repair of composite resin or compomer fillings
· Intraoral repair of composite restorations, porcelain fused to metal, and all-ceramic restorations without extra primer
· Protective varnish for glass ionomer fillings

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

	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Submitter

META BIOMED CO., LTD. Suk Song Oh 270, Osongsaengmyeong 1-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, South Korea Email: ef1459@metabiogw.bizmeka.com Phone: +82-43-230-8841 Fax: +82-43-217-1983

Device Information

Trade Name: EZ Bond Universal ●
. Classification Name: agent, tooth bonding, resin
Common Name: Resin Tooth Bonding Agent
. Product Code: KLE
Panel: Dental
Regulation Number: 21 CFR 872.3200
Device Class: Class II
Date prepared: 02/28/2023

Predicate Devices:

. K110302, ADHESIVE EXL-759 by 3M ESPE AG

Device Description

Indication for Use

. All classes of fillings (according to Black) with light-curing composite or compomer filling materials
. Repair of composite resin or compomer fillings
Intraoral repair of composite restorations, porcelain fused to metal, and all-ceramic restorations without extra primer
. Protective varnish for glass ionomer fillings

Official Correspondent

Withus Group Inc April Lee 106 Superior, Irvine, CA 92620 USA Email: withus6664@gmail.com Phone: 1-909-274-9971 Fax: 1-909-460-8122

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Non-clinical Testing

The subject device was tested to evaluation its safety and effectiveness according to the following standards:

Biocompatibility Tests according to ISO 10993-3:2014. ISO 10993-5:2009, ISO 10993-10:2010, -ISO 10993-11:2017.
Performance tests such as Film thickness, Sensitivity to ambient Light, Bond strength-Dentine, -Bond strength-enamel, Fine leakage according to ISO 4049:2019, ISO 29022:2013, ISO/TC 11405:2015
Shelf Life tests according to ISO 4049:2019, ISO 29022:2013. -

Summary of Technological Characteristics:

The subject device and predicate device have same intended use and principle of operation and similar technological characteristics such as capacity, film thickness, Sensitivity to Ambient Light, depth of cure, bond strength and shelf life.

The difference between the subject and predicate device is solubility. As the solubility value of the subject device is within the range that ISO 4049:2009, it doesn't affect safety and effectiveness.

	Subject Device	Predicate Device
Manufacturer	Meta Biomed Co., Ltd.	3M ESPE AG
Device Name	EZ Bond Universal	ADHESIVE EXL-759
510(k) Number	NA	K110302
Common Name	Resin Tooth Bonding Agent	Resin Tooth Bonding Agent
Product Code	KLE	KLE
RegulationNumber	21 CFR 872.3200	21 CFR 872.3200
Indications for Use	All classes of fillings(according to Black) withlight-curing composite orcompomer filling materialsRepair of composite resin orcompomer fillingsIntraoral repair of compositerestorations, porcelain fusedto metal, and all-ceramicrestorations without extraprimerProtective varnish for glassionomer fillings	All classes of fillings (according toBlack) with light-curing composite orcompomer filling materialsCementation of indirect restorationswhen combined with RelyX UltimateAdhesive Resin CementCementation of veneers when combinedwith RelyX Veneer CementBonding of core build-ups made of light-curing composite or core build-upmaterialsBonding of dual-cure cements and corebuild-up materials and self-curecomposites when combined with SingleBond Universal DCARepair of composite or compomerfillingsIntraoral repair of compositerestorations, porcelain fused to metal, and

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		all-ceramic restorations without extraprimer
		• Root surface desensitization
		• Sealing of cavities prior to cementationof amalgam restorations
		• Sealing of cavities and preparation oftooth stumps prior to temporarycementation of indirect restorations
		• Bonding of fissure sealants
		• Protective varnish for glass ionomerfillings
		• Surface treatment of porcelain, ceramics(including glass ceramics, zirconia andalumina), metal and composite.
Principle ofoperation	The device functions as anadhesive layer forenhancing an adhesivenessof polymerizable resin toadherends, and is used byapplying on the surface ofadherends.	The device functions as anadhesive layer forenhancing an adhesivenessof polymerizable resin toadherends, and is used byapplying on the surface ofadherends.
Raw Material	-MDP Phosphate Monomer-HEMA-Ethanol	-MDP Phosphate Monomer-HEMA-Ethanol
Film thickness	$4 \mu m$	$10.6 \mu m$
Sensitivity toAmbient	Material remained physicallyhomogeneous.	Material remained physicallyhomogeneous.
Bond strength,Dentine	23.2 Mpa	35.8 Mpa
Bond strength,enamel	23.7 Mpa	26.4 Mpa
Shelf Life	2 Years	2 Years

Conclusion:

Metabiomed Co., Ltd believes that EZ Bond Universal is substantially equivalent to currently legally marketed product. Product based on comparison of similar intended use and technologies tougher with the non-clinical performance testing. Any differences do not raise different questions of safety and effectiveness than the predicate, nor do they affect the safety or effectiveness of the subject device. These differences therefore, do not render the new device NSE in comparison to the predicate.

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.