DIAFIL & DIAFIL Capsule

K192510 · DiaDent Group International · EBF · Mar 20, 2020 · Dental

Device Facts

• Record ID: K192510
• Device Name: DIAFIL & DIAFIL Capsule
• Applicant: DiaDent Group International
• Product Code: EBF · Dental
• Decision Date: Mar 20, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

A composite material which has resin organic and inorganic fillers as ingredients, which are being used for aesthetic restoration by getting polymerized directly in the oral cavity. - Direct anterior and posterior restorations

Device Story

Nano-hybrid light-cured composite resin for dental restorations; consists of unpolymerized dimethacrylate monomers, inorganic fillers, and photoinitiators. Used by dentists in clinical settings for direct anterior and posterior restorations. Material is placed into the cavity and polymerized in situ using a dental visible-ray curing unit. Hardened restoration provides aesthetic repair of decayed or damaged tooth structure. Benefits include restoration of tooth form and function.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing including physical properties (flexural strength, water sorption, solubility, radio-opacity, depth of cure) per ISO 4049 and biocompatibility testing per ISO 10993 series (cytotoxicity, irritation, sensitization, systemic toxicity, genotoxicity).

Technological Characteristics

Nano-hybrid light-cured composite resin. Materials: Bis-GMA, TEGDMA, UDMA, Barium-alumino-silicate, Silica, Camphorquinone, Pigments. Form factor: Syringe or capsule. Energy source: External dental visible-ray polymerizer. Conforms to ISO 4049 (dentistry polymer-based restorative materials) and ISO 10993 (biocompatibility).

Indications for Use

Indicated for direct anterior and posterior aesthetic restorations in the oral cavity.

Regulatory Classification

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.

Predicate Devices

• DenFil (K042124)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. Underneath the FDA logo is the word "ADMINISTRATION".

March 20, 2020

Diadent Group International Kab Lee Quality Assurance Manager 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongu-si, 28161 Kr

### Re: K192510

Trade/Device Name: DIAFIL & DIAFIL Capsule Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: February 14, 2020 Received: February 20, 2020

### Dear Kab 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 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

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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 medical devices and radiation-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,

for Srinivas "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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K192510

Device Name DIAFIL & DIAFIL Capsule

Indications for Use (Describe)

A composite material which has resin organic and inorganic fillers as ingredients, which are being used for aesthetic restoration by getting polymerized directly in the oral cavity.

- Direct anterior and posterior restorations

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| <span> <span style="text-decoration: underline;"></span>Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | |
| <b>*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*</b> | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: | |
| Department of Health and Human Services<br>Food and Drug Administration<br>Office of Chief Information Officer<br>Paperwork Reduction Act (PRA) Staff<br><i>[e-mail]</i> | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of | |

of conduct of sponsor, and a person is not required to response 1

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# K192510 Diadent Group International

# 510(k) Summary

### 1.Application Information

| Date Prepared: | March 20, 2020 |
|------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Name and<br>Address: | DiaDent Group International<br>16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-<br>si, Chungcheongbuk-do, 28161, Republic of Korea |
| Contact Person: | Kab Sun, Lee<br>Quality Assurance Manager<br>Phone: [phone]<br>FAX: [phone]<br>Email: [e-mail] |

### 2.Device Information

| Trade Name | DIAFIL & DIAFIL Capsule |
|-------------------------|------------------------------|
| Device Type: | Tooth shade resin material |
| Regulation Description: | Material, Tooth Shade, Resin |
| Review Panel: | Dental |
| Regulation Number: | 21 CFR 872.3690 |
| Product Code: | EBF |
| Device Class: | II |

### 3.Predicate Devices

The legally marketed devices to which substantial equivalence is being claimed are:

| | Primary Predicate Device |
|--------------------|--------------------------|
| 510(k) Number: | K042124 |
| Applicant: | Vericom |
| Device Name: | DenFil |
| Regulation Number: | 21 CFR 872.3690 |
| Product Code: | EBF |
| Device Class: | II |

### 4.Products configuration

The subject device is packaged with the following:

| Package type | Components |
|----------------|---------------------------|
| Refill Package | 1 Syringe of product (4g) |
| Intro Kit | 1 Syringe of Product (1g) |
| Capsule | 1 Bottle (20capsules) |

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### 5.Device Description

The product belongs to Group 1, Class 2 of Type 1 according to the standard classification of ISO 4049. It is a nano hybrid typed light-curved complex resin for aesthetic restoration for both anterior and posterior parts, which is used for restoration that requires aesthetics through decay and damage in a form of paste with unpolymerized dimethacrylate monomer, inorganic filler, and photoinitiators mixed. That is, after recovering with the unpolymerized product, to make a hard restoration by polymerizing through dental visible-ray polymerizer.

### 6.Indications for Use

A composite material which has resin organic and inorganic fillers or complex fillers as ingredients, which are being used for aesthetic restoration by getting polymerized directly in the oral cavity. - Direct anterior and posterior restorations

### 7.Comparison with Predicate Device

### 7.1 Comparison Table

This device compares to the legally marketed devices as follows:

| | Subject Device | Primary Predicate Device | Image | | |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | DIAFIL & DIAFIL Capsule | DENFIL | Composition | - Bis-GMA<br>- TEGDMA<br>- UDMA<br>- Barium-alumino-silicate<br>- Silica<br>- Pigments | - Bis-GMA<br>- TEGDMA<br>- UDMA<br>- Bis-EMA<br>- Barium-alumino-silicate<br>- Silica<br>-Additives |
| | Diadent Group International | Vericom.Co., Ltd | Method of<br>use | 1) Select the shade<br>Separate the area to be treated using<br>rubber dam, etc. Wash the area. Select<br>the appropriate shade. | 1. Shade selection<br>Clean teeth with pumice and water to remove<br>surface stains or extraneous plaque. Teeth<br>are not monochromatic. Consider shade<br>and restoration depth. It is desirable to<br>choose the shade after mocking up.<br>Alternatively, Vita'Lumin® Vacuum shade<br>guide may be used. Using of rubber dam is<br>recommended for isolation. |
| 510(k)<br>Number | K192510 | K042124 | | 2) Treat the decayed parts<br>Remove amalgams or bases and<br>foreign substances at the area to be<br>treated that can be disturbing during the<br>treatment | 2. Cavity preparation<br>- Anterior restoration<br>Using the conventional acid etching, prepare<br>cavity for all Class III, Class IV, and Class V<br>restoration.<br>- Posterior restoration<br>Prepare the cavity. No residual amalgam or<br>other base material should be left on the<br>internal surfaces of preparation that would<br>interfere with light transmission and the<br>hardening of the restorative material. |
| Description | The product belongs to Group 1, Class 2<br>of Type 1 according to the standard<br>classification of ISO 4049. It is a nano<br>hybrid typed light-curved complex resin<br>for aesthetic restoration for both anterior<br>and posterior parts, which is used for<br>restoration that requires aesthetics<br>through decay and damage in a form of<br>paste with unpolymerized dimethacrylate<br>monomer, inorganic filler, and<br>photoinitiators mixed. That is, after<br>recovering with the unpolymerized<br>product, to make a hard restoration by<br>polymerizing through dental visible-ray<br>polymerizer. | DenFil™ is light-cured restorative hybrid<br>composite resin and accessories for use in<br>both posterior and anterior restoration.. | | 3) Pulp protection<br>When the decayed part is deep, the<br>pulp can be exposed. Therefore,<br>according to the indicant, cap the pulp<br>with calcium hydroxide and glass<br>ionomer. | 3. Pulp Protection<br>In deep cavities cover the dentin close to the<br>pulp with a minimum amount of calcium<br>hydroxide liner leaving the rest of cavity<br>surface free for bonding. Glass ionomer or<br>other eugenol-free base materials may be<br>used, if wished.<br>4. Placement of matrix<br>Use a matrix system, preferably a transparent<br>one, with proper<br>wedging for proximal contracts. Pre-wedging<br>is advocated to<br>achieve slight separation and facilitate<br>optimal proximal contact. |
| Indication for<br>Use | A composite material which has resin<br>organic and inorganic fillers or complex<br>fillers as ingredients, which are being<br>used for aesthetic restoration by getting<br>polymerized directly in the oral cavity.<br>- Direct anterior and posterior<br>restorations | DenFil™ is indicated for the following<br>restorative applications;<br>1. Class I, II, V restorations of posterior teeth<br>2. Class III, IV, V restorations of anterior teeth<br>3. Cervical cavities or defects involving root<br>surfaces | | | |

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### Diadent Group International

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### Diadent Group International

| | 4) Treatment of the enamel and the<br>dentine<br>For the pretreatment, according to<br>the method of use of the products in use,<br>operate acid etching and application of<br>adhesive system in order. | 5. Enamel and dentin treatment<br>Follow the manufacturer's instructions<br>regarding etching, priming,<br>adhesive application and curing. It is<br>recommended to use<br>DenFil™ Etchant-37 and BC Plus™ or U-<br>Bond™ |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 5) Application<br>-Open up the lid, take an adequate<br>amount of the product out, and fill the<br>resin at the area to be treated.<br>Make sure to close the lid after use to<br>prevent exposure to the light. | 6. Dispensing the composite<br>- Syringe<br>Dispense the necessary amount of<br>restorative material from the<br>syringe onto the mixing pad by turning the<br>handle slowly in a<br>clockwise manner.<br>A Universal Nano-hybrid Composite<br>Immediately replace syringe cap. If not used<br>immediately, the<br>dispensed material should be protected from<br>light. Place<br>restorative material into the cavity using<br>instrument contained. |
| | (For the capsule type, you can directly<br>restore the cavity using the dispenser. It<br>is disposal tip - dispose of it after use.) | - Single dose capsule<br>Insert capsule into dispenser and rotate to<br>gain the proper angle<br>of entrance into cavity. Extrude restorative<br>directly into cavity,<br>using a slow and steady pressure.<br>7. Placement<br>Place and light cure restorative in increments<br>in 2.5mm levels or<br>less. For permitting extension of composite<br>beyond cavity margins,<br>overfill the cavity slightly. Avoid intense light<br>in the working field. |
| | 6) Curing<br>Place a light projector as close as<br>possible with the surface of the product<br>filled and project the light for 20 seconds<br>vertically. (Usage recommendation: D-<br>Lux)<br>(Increase the amount of projection when<br>the projecting strength is below<br>400mW/cm2. If it is 400mW/cm2 or<br>higher, reduce the amount of projection.) | 8. Curing<br>Expose each area of restoration surface to a<br>visible light source<br>(400mW/cm²). Hold the light guide tip as close<br>to the restorative<br>materials as possible during light exposure.<br>The recommended<br>exposure time and maximum increment<br>thickness for each shade is<br>shown below. |
| | 7) Finishing up<br>After restoring with the resin, remove the<br>remaining resin with a flame-shaped<br>finishing bur and complete the shape.<br>Finish up the final grinding using a rubber<br>polishing point and aluminium oxide<br>polishing paste. | 9. Finishing<br>Immediately after curing contour restoration<br>surfaces with fine<br>finishing bur or stone. Carefully adjust<br>occlusion by removing<br>material with a fine polishing bur or stone. |
| Light curing<br>time | 20 seconds<br>(If light curing unit output is below<br>400mW/cm2, as measured by a<br>curing radiometer, more time may be<br>needed.)<br>A1, A2, A3, A3.5, B1, B2, C1 20sec<br>A2O, A3O, BL 30sec | 20 seconds<br>(If light curing unit output is below<br>400mW/cm2, as measured by a curing<br>radiometer, more time may be needed.) |

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#### Diadent Group International

| Human factor | Ready to use dispending system | Ready to use dispending system |
|----------------------------------------|-------------------------------------------|-------------------------------------------|
| Shelf life | 3 years | 2 years |
| Period of Use | Long term(> 30 days) | Long term(> 30 days) |
| Biocompatibil<br>ity | Biocompatible, conforming to ISO<br>10993 | Biocompatible, conforming to ISO<br>10993 |
| Performance<br>Standard<br>conformance | Meet ISO 4049 standard | Meet ISO 4049 standard |

### 7.2 differences

#### -Indication for Use

| Subject Device | Primary Predicate Device | Discussion |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| A composite material which has resin<br>organic and inorganic fillers or complex<br>fillers as ingredients, which are being<br>used for aesthetic restoration by getting<br>polymerized directly in the oral cavity.<br>- Direct anterior and posterior<br>restorations | DenFil™ is indicated for the following<br>restorative applications;<br>1. Class I, II, V restorations of posterior<br>teeth<br>2. Class III, IV, V restorations of<br>anterior teeth<br>3. Cervical cavities or defects involving<br>root surfaces | Intended use of both<br>devices include<br>restorations of restorations<br>of anterior teeth /<br>restorations posterior<br>teeth/ defects involving root<br>surfaces<br>Indication for use of both<br>devices is similar. |

### - Material composition

| Subject Device | Predicate Device | Function of ingredient |
|---------------------------------------|----------------------------------------------|------------------------|
| DIAFIL | DENFIL | |
| - Bis-GMA<br>- TEGDMA<br>- UDMA | - Bis-GMA<br>- TEGDMA<br>- UDMA<br>- Bis-EMA | Base liquid resin |
| - Barium-alumino-silicate<br>- Silica | - Barium-alumino-silicate<br>- Silica | Filler |
| Camphorquinone | Camphorquinone | Photoinitiator |
| Pigments | Additives | Colorant |

The raw material compositions of both devices are not identical but the main ingredient is similar and the role and functions are same. Also, the biocompatibility of raw material of subject device is confirmed by Biological safety study. Overall, the raw materials of both devices are similar.

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### Diadent Group International

### - Shelf life

The shelf life of the subject device is 3years and the shelf life of the predicate device is 2 years.

### 8. Non-Clinical Performance Data

This device has demonstrated conformance with non-clinical performance requirements through evaluation and testing in accordance with the following harmonized standards:

| -ISO 4049 | Dentistry -- Polymer-based restorative materials |
|---------------|----------------------------------------------------------------------------------------------------------------------------|
| -ISO 7405 | Dentistry - Evaluation Of Biocompatibility Of Medical<br>Devices Used In Dentistry [Including: Amendment 1<br>(2013)] |
| -ISO 10993-1 | Biological evaluation of medical devices - Part<br>1:Evaluation and testing within a risk management<br>process |
| -ISO 10993-3 | Biological evaluation of medical devices - Part 3: Tests<br>for genotoxicity, Carcinogenicity and reproductive<br>toxicity |
| -ISO 10993-5 | Biological evaluation of medical devices - Part 5. Tests<br>for in vitro Cytotoxicity |
| -ISO 10993-10 | Biological Evaluation Of Medical Devices - Part 10:<br>Tests For Irritation And Skin<br>Sensitization |
| -ISO 10993-11 | Biological Evaluation Of Medical Devices - Part 11:<br>Tests For Systemic Toxicity |

### The following Performance tests were conducted.

Performance test (Physical properties - ISO 4049:2009):

| Item | Requirement | Result | Pass/Fail |
|---------------------------------|--------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|-----------|
| Depth of cure | Opaque: shall be not less than<br>1 mm | Opaque : 2.8 mm (min value) | Pass |
| | Non opaque: shall be not less<br>than 1.5 mm | Non opaque :2.4 mm (min value) | |
| Sensitivity of<br>ambient light | Sample shall be no change in<br>consistency | There was no change in<br>consistency | Pass |
| Flexural strength | More than 80 Mpa | 92.6 Mpa (min value) | Pass |
| Water sorption | shall be less than 40 µg/mm³ | 5.7 µg/mm³ (max value) | Pass |
| Solubility | shall be less than 7.5 µg/mm³ | 0.7 µg / mm³ (max value) | Pass |
| Color | Color of samples shall be<br>matched closely with the<br>manufacturer's shade guide. | Color of samples was matched<br>closely with the manufacturer's<br>shade guide | Pass |
| Color stability | Shall be no color change | There was no color change | Pass |
| Radio-opacity | Sealer shall have radio-opacity<br>equivalent to not less than 3<br>mm of aluminum | Not less than 3 mm of aluminum | Pass |

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### Diadent Group International

Biocompatibility test:

| Test | Standard (AAMI/ANSI/ISO) |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Cytotoxicity | • 10993-5 Biological Evaluation of Medical Devices - Part 5: Tests<br>for in vitro Cytotoxicity |
| Oral mucosa irritation | •10993-10 Biological Evaluation of Medical Devices - Part 10:<br>Tests for irritation and skin sensitization |
| Skin sensitization<br>(LLNA) | •10993-10 Biological Evaluation of Medical Devices - Part 10:<br>Tests for irritation and skin sensitization |
| Acute Systemic Toxicity | • 10993-11 - Biological Evaluation of Medical Devices - Part 11:<br>Tests for Systemic Toxicity |
| Genetoxicity: Bacterial<br>Reverse Mutation | • 10993-3 - Biological Evaluation of Medical Devices - Part 3:<br>Tests for genotoxicity, carcinogenicity and reproductive toxicity |
| Genetoxicity: Micronucleus<br>test | • 10993-3 - Biological Evaluation of Medical Devices - Part 3:<br>Tests for genotoxicity, carcinogenicity and reproductive toxicity |

#### 9. Clinical Performance Data

No clinical data was collected or provided to support substantial equivalence between the subject and predicate devices.

#### 10. Conclusions

Based on the above information and all data provided in this submission, the comparison of intended uses, technological characteristics, and non-clinical performance testing demonstrates that the subject device is substantially equivalent to the legally marketed devices identified in this submission.