(59 days)
Not Found
No
The summary describes a chemical bonding agent and its performance characteristics, with no mention of AI or ML.
No.
The device is a bonding agent used in dental restorations and is classified as a Resin tooth bonding agent, not a therapeutic device. Its function is to facilitate the adhesion of filling materials, not to treat or cure a disease or medical condition.
No
The device is described as a tooth bonding agent used for restorative dental procedures, not for identifying or assessing a medical condition.
No
The device description clearly states it is a "single-bottle solution" and a "methacrylate-based restoratives, cement and sealant materials," indicating it is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses are all related to dental procedures for filling and repairing teeth. These are direct treatments applied to the patient's body.
- Device Description: The device is described as a "Resin tooth bonding agent" used for bonding restorative materials to tooth structure. This is a material used in a clinical setting on a patient.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
IVD devices are used to test samples (like blood, urine, tissue) outside of the body to gain information about a person's health status. This device is used directly on the patient's teeth for restorative purposes.
N/A
Intended Use / Indications 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
Product codes (comma separated list FDA assigned to the subject device)
KLE
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.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Film thickness: 4 micrometers
Sensitivity to Ambient Light: Material remained physically homogeneous.
Bond strength, Dentine: 23.2 Mpa
Bond strength, enamel: 23.7 Mpa
Shelf Life: 2 Years
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
1
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
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: 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 |
| Regulation | ||
| Number | 21 CFR 872.3200 | 21 CFR 872.3200 |
| Indications for Use | All classes of fillings | |
| (according to Black) with | ||
| light-curing composite or | ||
| compomer filling materialsRepair of composite resin or | ||
| compomer fillingsIntraoral repair of composite | ||
| restorations, porcelain fused | ||
| to metal, and all-ceramic | ||
| restorations without extra | ||
| primerProtective varnish for glass | ||
| ionomer fillings | All classes of fillings (according to | |
| Black) with light-curing composite or | ||
| compomer filling materialsCementation of indirect restorations | ||
| when combined with RelyX Ultimate | ||
| Adhesive Resin CementCementation of veneers when combined | ||
| with RelyX Veneer CementBonding of core build-ups made of light- | ||
| curing composite or core build-up | ||
| materialsBonding of dual-cure cements and core | ||
| build-up materials and self-cure | ||
| composites when combined with Single | ||
| Bond Universal DCARepair of composite or compomer | ||
| fillingsIntraoral repair of composite | ||
| restorations, porcelain fused to metal, and |
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| | | all-ceramic restorations without extra
primer |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | • Root surface desensitization |
| | | • Sealing of cavities prior to cementation
of amalgam restorations |
| | | • Sealing of cavities and preparation of
tooth stumps prior to temporary
cementation of indirect restorations |
| | | • Bonding of fissure sealants |
| | | • Protective varnish for glass ionomer
fillings |
| | | • Surface treatment of porcelain, ceramics
(including glass ceramics, zirconia and
alumina), metal and composite. |
| Principle of
operation | The device functions as an
adhesive layer for
enhancing an adhesiveness
of polymerizable resin to
adherends, and is used by
applying on the surface of
adherends. | The device functions as an
adhesive layer for
enhancing an adhesiveness
of polymerizable resin to
adherends, and is used by
applying on the surface of
adherends. |
| Raw Material | -MDP Phosphate Monomer
-HEMA
-Ethanol | -MDP Phosphate Monomer
-HEMA
-Ethanol |
| Film thickness | $4 \mu m$ | $10.6 \mu m$ |
| Sensitivity to
Ambient | Material remained physically
homogeneous. | Material remained physically
homogeneous. |
| 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.