(137 days)
DiaFil & DiaFil Capsule 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.
The provided document is a 510(k) summary for the Diafil & Diafil Capsule, a tooth shade resin material. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove acceptance criteria for a novel device or AI software. Therefore, much of the requested information regarding acceptance criteria and performance studies (e.g., sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) is not applicable or not available in this specific document.
The document primarily focuses on non-clinical performance and substantial equivalence based on material properties and intended use.
Here's a breakdown of the relevant information from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative sense for performance metrics of a device, but rather conformity to standards and comparability to predicate devices. The "Performance Standard conformance" in the comparison table serves as the closest equivalent to acceptance criteria for the material.
| Acceptance Criteria (Performance Standard Conformance) | Reported Device Performance |
|---|---|
| Meet ISO 4049 standard (Dentistry -- Polymer-based restorative materials) | Conforming (Subject device is stated to "Meet ISO 4049 standard") |
| Conforming to ISO 10993-1 (Biological evaluation of medical devices - Part 1) | Conforming (Subject device is stated to "Conforming to ISO 10993-1") |
| Other ISO 10993 standards (Part 3, 5, 10, 11) for biocompatibility | Conforming (Implied by stating conformance to ISO 10993-1 and listing other parts) |
2. Sample size used for the test set and the data provenance:
- Not applicable / Not provided. The document describes non-clinical bench testing and conformance to standards, not a specific "test set" in the context of clinical or AI performance evaluation. The data provenance is implied to be from the manufacturer's internal testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. This applies to clinical or AI studies, which were not conducted or reported for this submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. This applies to clinical or AI studies, which were not conducted or reported for this submission.
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:
- No. An MRMC study was not done. This device is a dental restorative material, 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 / Not provided. This device is a material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Standardized material property testing. The "ground truth" for this type of device is established through adherence to international standards (e.g., ISO 4049 for physical/chemical properties, ISO 10993 for biocompatibility). The testing involves measuring specific properties (e.g., flexural strength, water sorption, cytotoxicity) and comparing them against the requirements defined in these standards.
8. The sample size for the training set:
- Not applicable / Not provided. This concept is relevant for machine learning models, not for a dental restorative material.
9. How the ground truth for the training set was established:
- Not applicable / Not provided. This concept is relevant for machine learning models, not for a dental restorative material.
Summary from the document:
The 510(k) submission for Diafil & Diafil Capsule primarily relies on non-clinical performance data demonstrating conformance with harmonized international standards, specifically:
- ISO 4049: Dentistry -- Polymer-based restorative materials
- ISO 7405: Dentistry - Evaluation Of Biocompatibility Of Medical Devices Used In Dentistry
- ISO 10993-1: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- ISO 10993-3, 10993-5, 10993-10, 10993-11: Specific parts of ISO 10993 related to genotoxicity, cytotoxicity, irritation/sensitization, and systemic toxicity.
The document explicitly states: "No clinical data was collected or provided to support substantial equivalence between the subject and predicate devices." The basis for substantial equivalence is the comparison of device characteristics, indications for use, construction, composition, human factors, shelf life, period of use, biocompatibility, and performance standard conformance with legally marketed predicate devices. The "Change is only a package addition of DiaFil Capsule" and this addition "does not affect to the original product," which had already demonstrated safety and effectiveness through its own 510(k) clearances.
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June 28, 2021
Diadent Group International Kab Sun Lee Quality Assurance Manager 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu Cheongji-si, Chungcheongbuk-do 28161 SOUTH KOREA
Re: K210421/S002
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, KLE Dated: May 26, 2021 Received: June 1, 2021
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
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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,
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) K210421
Device Name DIAFIL & DIAFIL CAPSULE
Indications for Use (Describe)
DiaFil & DiaFil Capsule
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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510(k) Summary - K210421
1 Application Information
| Date Prepared: | February 8, 2021 |
|---|---|
| Company NameandAddress: | 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
| Subject Device | |
|---|---|
| Device Name: | DIAFIL & DIAFIL CAPSULE |
| Device Type: | Tooth shade resin material |
| Regulation Number: | 21 CFR 872.369021 CFR 872.3200 |
| Regulation Description: | Material, Tooth Shade, Resin |
| Product Code: | EBFKLE |
| Device Class: | II |
3 Predicate Devices
The legally marketed devices to which substantial equivalence is being claimed are:
| Primary PredicateDevice | Predicate Device(Subsequent device 1) | Predicate Device(Subsequent device 2) | |
|---|---|---|---|
| Device Name: | DIAFIL & DIAFILCAPSULE | DIAPLUS | DIAETCH |
| 510(k) Number: | K192510 | K192392 | K192273 |
| Applicant: | Diadent GroupInternational | Diadent GroupInternational | Diadent GroupInternational |
| RegulationNumber: | 21 CFR 872.3690 | 21 CFR 872.3200 | 21 CFR 872.3200 |
| Product Code: | EBF | KLE | KLE |
| Device Class: | II | II | II |
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4 Products configuration
| DiaFil Refill package | 1 syringe of DiaFil (4g) |
|---|---|
| DiaFil Intro Kit | 1 syringe of DiaFil (1g) |
| DiaFil Start Kit | 5 syringes of DiaFil (4g each)A bottle of DiaPlus (5ml)A syringe of DiaEtch (3ml)Accessories |
| DiaFil Capsule type | 20 capsule of DiaFil (0.25g) |
The subject device is packaged with the following:
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
DiaFil
A composite material which has resin organic 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
DiaPlus (DiaFil Start Kit Component)
As a dentine/enamel total etching bonding system for direct adhesion, it is used in the adhesion of all direction restoration substances.
- Bonding of direct composite
- Bonding to composite and set amalgam
- Bonding of indirect restoration-Porcelain, Composite (Inlays, Onlays, Veneers, Crowns)
DiaEtch (DiaFil Start Kit Component)
DiaEtch is a 37% phosphoric acid etchant used for etching enamel and dentin to promote adhesion of primer/bonding agent adhesives to tooth structure and restorative materials.
7 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 reproductive |
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Diadent Group International
Product Name : DIAFIL & DIAFIL CAPSULE
| toxicity | ||
|---|---|---|
| -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 |
Additional non-clinical bench testing demonstrates the safety and effectiveness of the subject device.
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510k SUBMISSION
Product Name : DIAFIL & DIAFIL CAPSULE
8 Substance Equivalence discussions
8.1 Comparison Table
This device compares to the legally marketed devices as follows:
| Primary Predicate Device(Original) | Predicate Device(Subsequent device 1) | Predicate Device(Subsequent device 2) | Subject Device | |
|---|---|---|---|---|
| DIAFIL & DIAFIL CAPSULE | DIAPLUS | DIAETCH | DIAFIL & DIAFIL CAPSULE | |
| 510(k) Number | K192510 | K192392 | K192273 | K210421 |
| Indication for Use | A composite material which has resinorganic and inorganic fillers orcomplex fillers as ingredients, whichare being used for aestheticrestoration by getting polymerizeddirectly in the oral cavity.- Direct anterior and posteriorrestorations | As a dentine/enamel total etchingbonding system for direct adhesion, itis used in the adhesion of all directionrestoration substances.- Bonding of direct composite- Bonding to composite and setamalgam- Bonding of indirect restoration-Porcelain, Composite (Inlays, Onlays,Veneers, Crowns) | DiaEtch is a 37% phosphoric acidetchant used for etching enamel anddentin to promote adhesion ofprimer/bonding agent adhesives totooth structure and restorativematerials. | DiaFil & DIAFIL CAPSULE: SameDiaPlus : SameDiaEtch : Same |
| DeviceDescription | The product belongs to Group 1,Class 2 of Type 1 according to thestandard classification of ISO 4049. Itis a nano hybrid typed light-curvedcomplex resin for aestheticrestoration for both anterior andposterior parts, which is used forrestoration that requires aestheticsthrough decay and damage in a formof paste with unpolymerizeddimethacrylate monomer, inorganicfiller, and photoinitiators mixed. Thatis, after recovering with theunpolymerized product, to make ahard restoration by polymerizing | DiaPlus is a photopolymerization typedentine and enamel adhesive as a5th generation dentine adhesionsystem that can be applied to alltypes of composite resin restorations.As a dentine/enamel total etchingbonding system for direct adhesion. Itis used in the adhesion of all directionrestoration substances. | Thixotropic dental etchant gel with37% phosphoric acid | DiaFil & DIAFIL CAPSULE: SameDiaPlus : SameDiaEtch : Same |
| through dental visible-raypolymerizer. | ||||
| Construction | 1) Refill package :1 syringe of DiaFil (4g)2) Intro Kit1 syringe of DiaFil (1g)3) Capsule type :20 capsule of DiaFil (0.25g) | One bottle of DiaPlus(5ml) | 1) Economic package5 syringe of DiaEtch (5ml each)20 disposable tips2) Regular package2 syringe of DiaEtch (3ml each)10 disposable tips3) Refill package1 syringe of DiaEtch(5ml)5 disposable tips | Model addition :DiaFil Start Kit5 syringes of DiaFil (4g each)A bottle of DiaPlus (5ml)A syringe of DiaEtch (3ml)Accessories :50 brush tips1 brush handle,A mixing well,A mixing pad,10 disposable tips,A shade sheet. |
| Composition | - Bis-GMA- TEGDMA- UDMA- Barium-alumino-silicate- Silica- Pigments | - Ethanol- UDMA (Urethane Dimethacrylate)- BisGMA (bisphenolA-glycidylmethacrylate)-TEGDMA (Triethylene glycoldimethacrylate)- HEMA succinate- Champhor quinone | - Phosphoric acid 37%- Water- Citric acid anhydrous- Silicon dioxide, (chemicallyprepared)- 1%-Methylene Blue solution- Xanthan Gum- Ethyl alcohol | DiaFil & DIAFIL CAPSULE: SameDiaPlus : SameDiaEtch : Same |
| Human factor | Ready to use dispensing system | Ready to use dispensing system | Ready to use dispensing system | DiaFil & DIAFIL CAPSULE: SameDiaPlus : SameDiaEtch : Same |
| Shelf life | 3 years | 2 years | 2 years | DiaFil & DIAFIL CAPSULE: SameDiaPlus : SameDiaEtch : Same |
| Period of Use | Permanent (> 30 d) | Permanent (> 30 d) | -limited (≤24 h) | DiaFil & DIAFIL CAPSULE: SameDiaPlus : SameDiaEtch : Same |
| Biocompatibility | Conforming to ISO 10993-1 | Conforming to ISO 10993-1 | Conforming to ISO 10993-1 | DiaFil & DIAFIL CAPSULE: SameDiaPlus : SameDiaEtch : Same |
| PerformanceStandardconformance | Meet ISO 4049 standard | Meet ISO 4049 standard | Meet ISO 4049 standard | DiaFil & DIAFIL CAPSULE: SameDiaPlus : SameDiaEtch : Same |
CONFIDENTIAL
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510k SUBMISSION
Diadent Group International
Product Name : DIAFIL & DIAFIL CAPSULE
CONFIDENTIAL
Pages 5 of 6
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8.2 Discussion :
The Change is only a package addition of DiaFil Capsule. The package includes 5" generation bonding agent (DiaPlus, K192392) and Etching agent (DiaEtch, K192273), which have already been proven to have Substantial product equivalence through the 510(k) decision of each product. The final package design of DIAFL START KT is added according to the configuration of package, but the products labeling of each components of package is not changed.
As the result of discussion of comparison, the package addition of DIAFIL CAPSULE does not affect to the original product.
9 Clinical Performance Data
No clinical data was collected or provided to support substantial equivalence between the subject and predicate devices.
10 Conclusions
Since the comparative products are components of the safely and effectiveness of subject product has already been proven in each aproved product. According to the conclusion, the subject device is practically the same as the predicale devices that are legally sold in market.
CONFIDENTIAL
§ 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.