EZ Bond Universal

K230009 · Meta Biomed Co., Ltd. · KLE · Mar 3, 2023 · Dental

Device Facts

• Record ID: K230009
• Device Name: EZ Bond Universal
• Applicant: Meta Biomed Co., Ltd.
• Product Code: KLE · Dental
• Decision Date: Mar 3, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3200
• Device Class: Class 2

Intended 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

Device Story

EZ Bond Universal is a single-bottle, methacrylate-based resin tooth bonding agent. It functions as an adhesive layer to bond restorative materials (composites, compomers) to dentin, enamel, and indirect substrates (glass ceramics, alumina, zirconia). Used by dental professionals in clinical settings; applied to tooth surfaces or restorative substrates. Supports self-etching, total-etching, or selective-etching procedures. Eliminates need for extra primer steps. Enhances adhesion of polymerizable resins to dental structures; improves clinical outcomes for direct and indirect restorations.

Clinical Evidence

Bench testing only. Biocompatibility evaluated per ISO 10993-3, -5, -10, -11. Performance testing included film thickness, sensitivity to ambient light, bond strength (dentin/enamel), and fine leakage per ISO 4049:2019, ISO 29022:2013, and ISO/TC 11405:2015. Shelf life validated per ISO standards.

Technological Characteristics

Single-bottle methacrylate-based resin bonding agent. Composition: MDP phosphate monomer, HEMA, ethanol. Principle: Adhesive layer for polymerizable resin. Film thickness: 4 µm. Shelf life: 2 years. Biocompatibility: ISO 10993 compliant. Performance standards: ISO 4049, ISO 29022, ISO/TC 11405.

Indications for Use

Indicated for patients requiring dental restorations, including all classes of fillings (Black's classification) using light-curing composite or compomer materials, repair of composite/compomer fillings, intraoral repair of composite, porcelain-fused-to-metal, and all-ceramic restorations, and as a protective varnish for glass ionomer fillings.

Regulatory Classification

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.

Predicate Devices

• ADHESIVE EXL-759 (K110302)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: [e-mail] Phone: [phone] Fax: [phone]

#### 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

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.

#### 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: [e-mail] Phone: [phone] Fax: [phone]

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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 |
| Regulation<br>Number | 21 CFR 872.3200 | 21 CFR 872.3200 |
| Indications for Use | All classes of fillings<br>(according to Black) with<br>light-curing composite or<br>compomer filling materialsRepair of composite resin or<br>compomer fillingsIntraoral repair of composite<br>restorations, porcelain fused<br>to metal, and all-ceramic<br>restorations without extra<br>primerProtective varnish for glass<br>ionomer fillings | All classes of fillings (according to<br>Black) with light-curing composite or<br>compomer filling materialsCementation of indirect restorations<br>when combined with RelyX Ultimate<br>Adhesive Resin CementCementation of veneers when combined<br>with RelyX Veneer CementBonding of core build-ups made of light-<br>curing composite or core build-up<br>materialsBonding of dual-cure cements and core<br>build-up materials and self-cure<br>composites when combined with Single<br>Bond Universal DCARepair of composite or compomer<br>fillingsIntraoral repair of composite<br>restorations, porcelain fused to metal, and |

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| | | all-ceramic restorations without extra<br>primer |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | • Root surface desensitization |
| | | • Sealing of cavities prior to cementation<br>of amalgam restorations |
| | | • Sealing of cavities and preparation of<br>tooth stumps prior to temporary<br>cementation of indirect restorations |
| | | • Bonding of fissure sealants |
| | | • Protective varnish for glass ionomer<br>fillings |
| | | • Surface treatment of porcelain, ceramics<br>(including glass ceramics, zirconia and<br>alumina), metal and composite. |
| Principle of<br>operation | The device functions as an<br>adhesive layer for<br>enhancing an adhesiveness<br>of polymerizable resin to<br>adherends, and is used by<br>applying on the surface of<br>adherends. | The device functions as an<br>adhesive layer for<br>enhancing an adhesiveness<br>of polymerizable resin to<br>adherends, and is used by<br>applying on the surface of<br>adherends. |
| Raw Material | -MDP Phosphate Monomer<br>-HEMA<br>-Ethanol | -MDP Phosphate Monomer<br>-HEMA<br>-Ethanol |
| Film thickness | $4 \mu m$ | $10.6 \mu m$ |
| Sensitivity to<br>Ambient | Material remained physically<br>homogeneous. | Material remained physically<br>homogeneous. |
| Bond strength,<br>Dentine | 23.2 Mpa | 35.8 Mpa |
| Bond strength,<br>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.