(224 days)
- Direct anterior and posterior restorations (including occlusal surfaces)
- Core Build-ups
- Splinting
- Indirect restorations including inlays, onlays and veneers
Dental composite resin is a device intended to restore carious lesions or structural defects in teeth.
Ezfil is indicated for Class I , II, IV, V restorations, Core-buildup to replace missing tooth structure, Diastema closures, Direct veneers, Composite and porcelain repairs.
The color is 18 colors with A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4, OP and TL.
The document provided details for a traditional medical device (dental resin) and not a medical device with AI/ML components. Therefore, much of the requested information regarding AI/ML device testing (e.g., sample size for test/training sets, expert qualifications, MRMC studies) is not applicable or available in this document.
However, I can extract the acceptance criteria and performance data for the non-clinical tests performed on the Ezfil device, which are relevant to its substantial equivalence determination.
1. A table of acceptance criteria and the reported device performance
The document states that performance tests were conducted "according to EN ISO 4049:2009" and other ISO standards. Conformance to these standards serves as the acceptance criteria. The document explicitly states that the device "Conformed to ISO 4049" and that "the test results provided in this submission supports that it is substantially equivalent to the primary predicate." While specific numerical performance values are not provided in this summary, the acceptance is that the device meets the requirements of these standards.
| Acceptance Criteria (Standard Conformance) | Reported Device Performance |
|---|---|
| EN ISO 10993-1:2009 (Biocompatibility) | Yes |
| EN ISO 10993-3:2014 (Biocompatibility) | Yes |
| EN ISO 10993-5:2009 (Biocompatibility) | Yes |
| EN ISO 10993-10:2013 (Biocompatibility) | Yes |
| ISO 10993-11:2009 (Biocompatibility) | Yes |
| EN ISO 4049:2009 (Dental Polymer-Based Restorative Materials) | Conformed |
| ISO 3107:2011 (Dental Zinc Oxide/Eugenol Cements and Zinc Phosphate Cements) | Conformed |
| ISO 6507-1:2005 (Metallic Materials - Vickers Hardness Test) | Conformed |
| Shelf Life (3 years) | 3 years |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The tests are non-clinical, likely laboratory-based, and performed on material samples rather than clinical patient data. The manufacturer is based in South Korea (Meta Biomed Co., Ltd.).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is a non-clinical device that does not involve expert interpretation or ground truth establishment in the context of diagnostic performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a non-clinical device.
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
Not applicable. This is a non-AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a non-AI/ML device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" or reference standard would be the defined physical, chemical, and biological properties as specified in the referenced ISO and EN ISO standards. For biocompatibility, this refers to the absence of adverse biological reactions. For performance tests (depth of cure, flexural strength, etc.), it refers to meeting the quantitative limits or qualitative descriptions set by the standards.
8. The sample size for the training set
Not applicable. This is a non-AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is a non-AI/ML device.
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March 05, 2020
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Meta Biomed Co., Ltd. % April Lee Consultant Withus Group Inc 106 Superior Irvine, California 92620
Re: K191991
Trade/Device Name: Ezfil Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: December 2, 2019 Received: December 6, 2019
Dear April Lee:
We have reviewed vour 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,
For Srivinas 'Nandu' Nandkumar, Ph.D. Director DHT1B: Division of Dental 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) K191991
Device Name
Ezfil
Indications for Use (Describe)
- Direct anterior and posterior restorations (including occlusal surfaces)
- Core Build-ups
- Splinting
- Indirect restorations including inlays, onlays and veneers
| 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: Ezfil ●
- . Classification Name: Tooth Shade Resin Material
- Product Code: EBF
- Panel: Dental
- Regulation Number: 21 CFR 872.3690
- Device Class: Class II
- Date prepared: 03/05/2020
Primary Predicate Device:
- · K083610, Filtek Supreme Ultra Universal Restorative manufactured by 3M COMPANY
Device Description
Dental composite resin is a device intended to restore carious lesions or structural defects in teeth.
Ezfil is indicated for Class I , II, IV, V restorations, Core-buildup to replace missing tooth structure, Diastema closures, Direct veneers, Composite and porcelain repairs.
The color is 18 colors with A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4, OP and TL.
Indication for Use
- Direct anterior and posterior restorations (including occlusal surfaces) ●
- Core Build-ups
- Splinting
- Indirect restorations including inlays, onlays and veneers
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 following testing was conducted on our subject device:
- Biocompatibility Tests according to EN ISO 10993-1:2009, EN ISO 10993-3:2014, EN ISO 10993-. 5:2009, EN ISO 10993-10:2013, ISO 10993-11:2009.
- . Performance tests such as Sensitivity of ambient light, Depth of cure, Shade, Color Stability, Flexural strength, Water Sorption, Solubility and Radio-opacity according to EN ISO 4049:2009.
- Shelf Life test: ISO 4049 tests (Package, Sensitivity to Ambient Light, Depth of Cure, Shade, . Colour Stability, Flexural Strength)
- Compressive Testing according to ISO 3107:2011 ●
- Surface Hardness Testing according to ISO 6507-1:2005 ●
Summary of Technological Characteristics:
The subject device and the primary predicate device have intended use and have the similar technological characteristics and are made of similar materials. They encompass the same range of physical and chemical properties. The subject device and predicate devices are packaged in similar material and use similar methods of application.
The subject device is different from the primary predicate device in raw materials, however, the test results provided in this submission supports that it is substantially equivalent to the primary predicate.
| Subject Device | Primary Predicate Device | |
|---|---|---|
| Manufacturer | Meta Biomed Co., Ltd. | 3M COMPANY |
| Device Name | Ezfil | Filtek Supreme Ultra UniversalRestorative |
| 510(k) Number | K191991 | K083610 |
| ClassificationName | Tooth shade resin material | Tooth shade resin material |
| Product Code | EBF | EBF |
| RegulationNumber | 21 CFR 872.3690 | 21 CFR 872.3690 |
| Indications for use | ● Direct anterior and posteriorrestorations (including occlusalsurfaces)● Core Build-ups● Splinting● Indirect restorations includinginlays, onlays and veneers | ● Direct anterior and posteriorrestorations (includingocclusal surfaces)● Core Build-ups● Splinting● Indirect restorations includinginlays, onlays and veneers |
| Raw Material | - Bis-GMA- UDMA | - Bis-GMA- UDMA |
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| - Bis-EMA- TEGDMA- 4-EDAB- Camphorquinone- BP- BHT- Barium Glass- Silica- PVP | - Bis-EMA- TEGDMA- PEGDMA- Silane treated ceramic- Silane treated silica- Silane treated zirconia | |
|---|---|---|
| Principle ofOperation | All shades are radiopaque | All shades are radiopaque |
| PerformanceStandardConformance | Conformed to ISO 4049 | Conformed to ISO 4049 |
| Biocompatibility | Yes | Yes |
| Intended Operator | Dentist | Dentist |
| Shelf Life | 3 years | 3 years |
Conclusion:
Based on documentation supplied with this submission, conclusions drawn from the testing results demonstrate that the subject device is substantially equivalent to our legally marketed primary predicate device.
§ 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.