(224 days)
Not Found
No
The device description and performance studies focus on the material properties and clinical performance of a dental composite resin, with no mention of AI or ML.
Yes
The device is a restorative material used to treat carious lesions or structural defects in teeth, which are considered therapeutic interventions.
No
The device description indicates it is a dental composite resin used for restoring teeth, not for diagnosing conditions. It is a restorative material used after a diagnosis has already been made.
No
The device description clearly states it is a "Dental composite resin," which is a physical material used to restore teeth, not a software application. The performance studies also focus on material properties like biocompatibility, strength, and color stability, further indicating it is a physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description and Intended Use: The description clearly states that this device is a "Dental composite resin" intended to "restore carious lesions or structural defects in teeth." It is applied directly to the teeth.
- Anatomical Site: The anatomical site is "Teeth," which are part of the body but the device is used to restore their structure, not to analyze a specimen taken from them.
- Performance Studies: The performance studies listed focus on the physical and chemical properties of the material itself (biocompatibility, strength, color stability, etc.) and its performance in restoring teeth, not on analyzing biological samples.
The device is a dental restorative material, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
- Direct anterior and posterior restorations (including occlusal surfaces)
- Core Build-ups
- Splinting
- Indirect restorations including inlays, onlays and veneers
Product codes (comma separated list FDA assigned to the subject device)
EBF
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.
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
Dentist
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)
Non-clinical Testing:
- 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
Key results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
§ 872.3690 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.
0
March 05, 2020
Image /page/0/Picture/11 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it.
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
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,
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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3
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 Universal |
| Restorative | ||
| 510(k) Number | K191991 | K083610 |
| Classification | ||
| Name | Tooth shade resin material | Tooth shade resin material |
| Product Code | EBF | EBF |
| Regulation | ||
| Number | 21 CFR 872.3690 | 21 CFR 872.3690 |
| Indications for use | ● Direct anterior and posterior | |
| restorations (including occlusal | ||
| surfaces) | ||
| ● Core Build-ups | ||
| ● Splinting | ||
| ● Indirect restorations including | ||
| inlays, onlays and veneers | ● Direct anterior and posterior | |
| restorations (including | ||
| occlusal surfaces) | ||
| ● Core Build-ups | ||
| ● Splinting | ||
| ● Indirect restorations including | ||
| inlays, onlays and veneers | ||
| Raw Material | - Bis-GMA |
- UDMA | - Bis-GMA
- UDMA |
5
| | - 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 of
Operation | All shades are radiopaque | All shades are radiopaque |
| Performance
Standard
Conformance | 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.