(190 days)
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
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.
Here's a breakdown of the acceptance criteria and study information based on the provided text, where applicable:
1. Table of acceptance criteria and the reported device performance:
| Item | Acceptance Criteria (Requirement) | Reported Device Performance (Result) | Pass/Fail |
|---|---|---|---|
| Depth of cure | Opaque: not less than 1 mm Non-opaque: not less than 1.5 mm | Opaque: 2.8 mm (min value) Non-opaque: 2.4 mm (min value) | Pass |
| Sensitivity of ambient light | No change in consistency | No change in consistency | Pass |
| Flexural strength | More than 80 Mpa | 92.6 Mpa (min value) | Pass |
| Water sorption | Less than 40 µg/mm³ | 5.7 µg/mm³ (max value) | Pass |
| Solubility | Less than 7.5 µg/mm³ | 0.7 µg/mm³ (max value) | Pass |
| Color | Color of samples shall be matched closely with the manufacturer's shade guide | Color of samples was matched closely with the manufacturer's shade guide | Pass |
| Color stability | No color change | No color change | Pass |
| Radio-opacity | Equivalent to not less than 3 mm of aluminum | Not less than 3 mm of aluminum | Pass |
| Biocompatibility | Biocompatible, conforming to ISO 10993 (implied acceptance for each specific test) | Confirmed through various ISO 10993 tests (Cytotoxicity, Oral mucosa irritation, Skin sensitization, Acute Systemic Toxicity, Genetoxicity: Bacterial Reverse Mutation, Genetoxicity: Micronucleus test) | Pass |
| Performance Standard (General) | Meet ISO 4049 standard | Meet ISO 4049 standard (stated directly) | Pass |
2. Sample size used for the test set and the data provenance:
The document describes non-clinical performance data and biocompatibility tests. It does not specify the exact sample sizes for each of these tests, nor the country of origin of the data. It is implicitly retrospective as it's a submission for regulatory clearance based on completed tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The tests described are non-clinical, laboratory-based performance and biocompatibility studies, not studies involving expert interpretation or "ground truth" derived from human assessment in the way that would apply to, for example, medical imaging or diagnostic devices.
4. Adjudication method for the test set:
Not applicable. This is not a study requiring adjudication of expert interpretations.
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 device is a dental restorative material (tooth shade resin), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a dental restorative material, not an algorithm.
7. The type of ground truth used:
For the non-clinical performance tests, the "ground truth" is established by the specifications and acceptance criteria defined in the harmonized standards (e.g., ISO 4049). For biocompatibility, the "ground truth" is determined by meeting the specified endpoints and requirements of the relevant ISO 10993 standards (e.g., no cytotoxicity, no irritation, etc.).
8. The sample size for the training set:
Not applicable. This is a material device, not a machine learning model.
9. How the ground truth for the training set was established:
Not applicable. This is a material device, not a machine learning model.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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K192510 Diadent Group International
510(k) Summary
1.Application Information
| Date Prepared: | March 20, 2020 |
|---|---|
| Company Name andAddress: | DiaDent Group International16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, 28161, Republic of Korea |
| Contact Person: | Kab Sun, LeeQuality Assurance ManagerPhone: +82-43-266-2315FAX: +82-43-235-2315Email: diadent32@diadent.co.kr |
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- TEGDMA- UDMA- Barium-alumino-silicate- Silica- Pigments | - Bis-GMA- TEGDMA- UDMA- Bis-EMA- Barium-alumino-silicate- Silica-Additives | |
| Diadent Group International | Vericom.Co., Ltd | Method ofuse | 1) Select the shadeSeparate the area to be treated usingrubber dam, etc. Wash the area. Selectthe appropriate shade. | 1. Shade selectionClean teeth with pumice and water to removesurface stains or extraneous plaque. Teethare not monochromatic. Consider shadeand restoration depth. It is desirable tochoose the shade after mocking up.Alternatively, Vita'Lumin® Vacuum shadeguide may be used. Using of rubber dam isrecommended for isolation. | |
| 510(k)Number | K192510 | K042124 | 2) Treat the decayed partsRemove amalgams or bases andforeign substances at the area to betreated that can be disturbing during thetreatment | 2. Cavity preparation- Anterior restorationUsing the conventional acid etching, preparecavity for all Class III, Class IV, and Class Vrestoration.- Posterior restorationPrepare the cavity. No residual amalgam orother base material should be left on theinternal surfaces of preparation that wouldinterfere with light transmission and thehardening of the restorative material. | |
| Description | The product belongs to Group 1, Class 2of Type 1 according to the standardclassification of ISO 4049. It is a nanohybrid typed light-curved complex resinfor aesthetic restoration for both anteriorand posterior parts, which is used forrestoration that requires aestheticsthrough decay and damage in a form ofpaste with unpolymerized dimethacrylatemonomer, inorganic filler, andphotoinitiators mixed. That is, afterrecovering with the unpolymerizedproduct, to make a hard restoration bypolymerizing through dental visible-raypolymerizer. | DenFil™ is light-cured restorative hybridcomposite resin and accessories for use inboth posterior and anterior restoration.. | 3) Pulp protectionWhen the decayed part is deep, thepulp can be exposed. Therefore,according to the indicant, cap the pulpwith calcium hydroxide and glassionomer. | 3. Pulp ProtectionIn deep cavities cover the dentin close to thepulp with a minimum amount of calciumhydroxide liner leaving the rest of cavitysurface free for bonding. Glass ionomer orother eugenol-free base materials may beused, if wished.4. Placement of matrixUse a matrix system, preferably a transparentone, with properwedging for proximal contracts. Pre-wedgingis advocated toachieve slight separation and facilitateoptimal proximal contact. | |
| Indication forUse | A composite material which has resinorganic and inorganic fillers or complexfillers as ingredients, which are beingused for aesthetic restoration by gettingpolymerized directly in the oral cavity.- Direct anterior and posteriorrestorations | DenFil™ is indicated for the followingrestorative applications;1. Class I, II, V restorations of posterior teeth2. Class III, IV, V restorations of anterior teeth3. Cervical cavities or defects involving rootsurfaces |
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Diadent Group International
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Diadent Group International
| 4) Treatment of the enamel and thedentineFor the pretreatment, according tothe method of use of the products in use,operate acid etching and application ofadhesive system in order. | 5. Enamel and dentin treatmentFollow the manufacturer's instructionsregarding etching, priming,adhesive application and curing. It isrecommended to useDenFil™ Etchant-37 and BC Plus™ or U-Bond™ | |
|---|---|---|
| 5) Application-Open up the lid, take an adequateamount of the product out, and fill theresin at the area to be treated.Make sure to close the lid after use toprevent exposure to the light. | 6. Dispensing the composite- SyringeDispense the necessary amount ofrestorative material from thesyringe onto the mixing pad by turning thehandle slowly in aclockwise manner.A Universal Nano-hybrid CompositeImmediately replace syringe cap. If not usedimmediately, thedispensed material should be protected fromlight. Placerestorative material into the cavity usinginstrument contained. | |
| (For the capsule type, you can directlyrestore the cavity using the dispenser. Itis disposal tip - dispose of it after use.) | - Single dose capsuleInsert capsule into dispenser and rotate togain the proper angleof entrance into cavity. Extrude restorativedirectly into cavity,using a slow and steady pressure.7. PlacementPlace and light cure restorative in incrementsin 2.5mm levels orless. For permitting extension of compositebeyond cavity margins,overfill the cavity slightly. Avoid intense lightin the working field. | |
| 6) CuringPlace a light projector as close aspossible with the surface of the productfilled and project the light for 20 secondsvertically. (Usage recommendation: D-Lux)(Increase the amount of projection whenthe projecting strength is below400mW/cm2. If it is 400mW/cm2 orhigher, reduce the amount of projection.) | 8. CuringExpose each area of restoration surface to avisible light source(400mW/cm²). Hold the light guide tip as closeto the restorativematerials as possible during light exposure.The recommendedexposure time and maximum incrementthickness for each shade isshown below. | |
| 7) Finishing upAfter restoring with the resin, remove theremaining resin with a flame-shapedfinishing bur and complete the shape.Finish up the final grinding using a rubberpolishing point and aluminium oxidepolishing paste. | 9. FinishingImmediately after curing contour restorationsurfaces with finefinishing bur or stone. Carefully adjustocclusion by removingmaterial with a fine polishing bur or stone. | |
| Light curingtime | 20 seconds(If light curing unit output is below400mW/cm2, as measured by acuring radiometer, more time may beneeded.)A1, A2, A3, A3.5, B1, B2, C1 20secA2O, A3O, BL 30sec | 20 seconds(If light curing unit output is below400mW/cm2, as measured by a curingradiometer, 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) |
| Biocompatibility | Biocompatible, conforming to ISO10993 | Biocompatible, conforming to ISO10993 |
| PerformanceStandardconformance | 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 resinorganic and inorganic fillers or complexfillers as ingredients, which are beingused for aesthetic restoration by gettingpolymerized directly in the oral cavity.- Direct anterior and posteriorrestorations | DenFil™ is indicated for the followingrestorative applications;1. Class I, II, V restorations of posteriorteeth2. Class III, IV, V restorations ofanterior teeth3. Cervical cavities or defects involvingroot surfaces | Intended use of bothdevices includerestorations of restorationsof anterior teeth /restorations posteriorteeth/ defects involving rootsurfacesIndication for use of bothdevices is similar. |
- Material composition
| Subject Device | Predicate Device | Function of ingredient |
|---|---|---|
| DIAFIL | DENFIL | |
| - Bis-GMA- TEGDMA- UDMA | - Bis-GMA- TEGDMA- UDMA- Bis-EMA | Base liquid resin |
| - Barium-alumino-silicate- Silica | - Barium-alumino-silicate- 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 MedicalDevices Used In Dentistry [Including: Amendment 1(2013)] |
| -ISO 10993-1 | Biological evaluation of medical devices - Part1:Evaluation and testing within a risk managementprocess |
| -ISO 10993-3 | Biological evaluation of medical devices - Part 3: Testsfor genotoxicity, Carcinogenicity and reproductivetoxicity |
| -ISO 10993-5 | Biological evaluation of medical devices - Part 5. Testsfor in vitro Cytotoxicity |
| -ISO 10993-10 | Biological Evaluation Of Medical Devices - Part 10:Tests For Irritation And SkinSensitization |
| -ISO 10993-11 | Biological Evaluation Of Medical Devices - Part 11: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 than1 mm | Opaque : 2.8 mm (min value) | Pass |
| Non opaque: shall be not lessthan 1.5 mm | Non opaque :2.4 mm (min value) | ||
| Sensitivity ofambient light | Sample shall be no change inconsistency | There was no change inconsistency | 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 bematched closely with themanufacturer's shade guide. | Color of samples was matchedclosely with the manufacturer'sshade guide | Pass |
| Color stability | Shall be no color change | There was no color change | Pass |
| Radio-opacity | Sealer shall have radio-opacityequivalent to not less than 3mm 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: Testsfor in vitro Cytotoxicity |
| Oral mucosa irritation | •10993-10 Biological Evaluation of Medical Devices - Part 10:Tests for irritation and skin sensitization |
| Skin sensitization(LLNA) | •10993-10 Biological Evaluation of Medical Devices - Part 10:Tests for irritation and skin sensitization |
| Acute Systemic Toxicity | • 10993-11 - Biological Evaluation of Medical Devices - Part 11:Tests for Systemic Toxicity |
| Genetoxicity: BacterialReverse Mutation | • 10993-3 - Biological Evaluation of Medical Devices - Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity |
| Genetoxicity: Micronucleustest | • 10993-3 - Biological Evaluation of Medical Devices - Part 3: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.
§ 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.