Diafil & Diafil Capsule

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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 {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, 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 {2}------------------------------------------------ ## 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) | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <span> </span> <span> </span> </div> <div> <span> </span> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> </span> <span> </span> </div> <div> <span> </span> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW! * 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 Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 510(k) Summary - K210421 ### 1 Application Information | Date Prepared: | February 8, 2021 | |---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------| | Company Name<br>and<br>Address: | DiaDent Group International<br>16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu,<br>Cheongju-si, Chungcheongbuk-do, 28161, Republic of Korea | | Contact Person: | Kab Sun, Lee<br>Quality Assurance Manager<br>Phone: +82-43-266-2315<br>FAX: +82-43-235-2315<br>Email: diadent32@diadent.co.kr | #### 2 Device Information | | Subject Device | |-------------------------|------------------------------------| | Device Name: | DIAFIL & DIAFIL CAPSULE | | Device Type: | Tooth shade resin material | | Regulation Number: | 21 CFR 872.3690<br>21 CFR 872.3200 | | Regulation Description: | Material, Tooth Shade, Resin | | Product Code: | EBF<br>KLE | | Device Class: | II | ## 3 Predicate Devices The legally marketed devices to which substantial equivalence is being claimed are: | | Primary Predicate<br>Device | Predicate Device<br>(Subsequent device 1) | Predicate Device<br>(Subsequent device 2) | |-----------------------|--------------------------------|-------------------------------------------|-------------------------------------------| | Device Name: | DIAFIL & DIAFIL<br>CAPSULE | DIAPLUS | DIAETCH | | 510(k) Number: | K192510 | K192392 | K192273 | | Applicant: | Diadent Group<br>International | Diadent Group<br>International | Diadent Group<br>International | | Regulation<br>Number: | 21 CFR 872.3690 | 21 CFR 872.3200 | 21 CFR 872.3200 | | Product Code: | EBF | KLE | KLE | | Device Class: | II | II | II | {4}------------------------------------------------ #### 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)<br>A bottle of DiaPlus (5ml)<br>A syringe of DiaEtch (3ml)<br>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 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 | {5}------------------------------------------------ ## Diadent Group International ## Product Name : DIAFIL & DIAFIL CAPSULE | | 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 | | Additional non-clinical bench testing demonstrates the safety and effectiveness of the subject device. {6}------------------------------------------------ 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<br>(Original) | Predicate Device<br>(Subsequent device 1) | Predicate Device<br>(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 resin<br>organic and inorganic fillers or<br>complex fillers as ingredients, which<br>are being used for aesthetic<br>restoration by getting polymerized<br>directly in the oral cavity.<br>- Direct anterior and posterior<br>restorations | As a dentine/enamel total etching<br>bonding system for direct adhesion, it<br>is used in the adhesion of all direction<br>restoration substances.<br>- Bonding of direct composite<br>- Bonding to composite and set<br>amalgam<br>- Bonding of indirect restoration-<br>Porcelain, Composite (Inlays, Onlays,<br>Veneers, Crowns) | DiaEtch is a 37% phosphoric acid<br>etchant used for etching enamel and<br>dentin to promote adhesion of<br>primer/bonding agent adhesives to<br>tooth structure and restorative<br>materials. | DiaFil & DIAFIL CAPSULE: Same<br>DiaPlus : Same<br>DiaEtch : Same | | Device<br>Description | The product belongs to Group 1,<br>Class 2 of Type 1 according to the<br>standard classification of ISO 4049. It<br>is a nano hybrid typed light-curved<br>complex resin for aesthetic<br>restoration for both anterior and<br>posterior parts, which is used for<br>restoration that requires aesthetics<br>through decay and damage in a form<br>of paste with unpolymerized<br>dimethacrylate monomer, inorganic<br>filler, and photoinitiators mixed. That<br>is, after recovering with the<br>unpolymerized product, to make a<br>hard restoration by polymerizing | DiaPlus is a photopolymerization type<br>dentine and enamel adhesive as a<br>5th generation dentine adhesion<br>system that can be applied to all<br>types of composite resin restorations.<br>As a dentine/enamel total etching<br>bonding system for direct adhesion. It<br>is used in the adhesion of all direction<br>restoration substances. | Thixotropic dental etchant gel with<br>37% phosphoric acid | DiaFil & DIAFIL CAPSULE: Same<br>DiaPlus : Same<br>DiaEtch : Same | | | through dental visible-ray<br>polymerizer. | | | | | Construction | 1) Refill package :<br>1 syringe of DiaFil (4g)<br>2) Intro Kit<br>1 syringe of DiaFil (1g)<br>3) Capsule type :<br>20 capsule of DiaFil (0.25g) | One bottle of DiaPlus(5ml) | 1) Economic package<br>5 syringe of DiaEtch (5ml each)<br>20 disposable tips<br>2) Regular package<br>2 syringe of DiaEtch (3ml each)<br>10 disposable tips<br>3) Refill package<br>1 syringe of DiaEtch(5ml)<br>5 disposable tips | Model addition :<br>DiaFil Start Kit<br>5 syringes of DiaFil (4g each)<br>A bottle of DiaPlus (5ml)<br>A syringe of DiaEtch (3ml)<br>Accessories :<br>50 brush tips<br>1 brush handle,<br>A mixing well,<br>A mixing pad,<br>10 disposable tips,<br>A shade sheet. | | Composition | - Bis-GMA<br>- TEGDMA<br>- UDMA<br>- Barium-alumino-silicate<br>- Silica<br>- Pigments | - Ethanol<br>- UDMA (Urethane Dimethacrylate)<br>- BisGMA (bisphenolA-glycidyl<br>methacrylate)<br>-TEGDMA (Triethylene glycol<br>dimethacrylate)<br>- HEMA succinate<br>- Champhor quinone | - Phosphoric acid 37%<br>- Water<br>- Citric acid anhydrous<br>- Silicon dioxide, (chemically<br>prepared)<br>- 1%-Methylene Blue solution<br>- Xanthan Gum<br>- Ethyl alcohol | DiaFil & DIAFIL CAPSULE: Same<br>DiaPlus : Same<br>DiaEtch : Same | | Human factor | Ready to use dispensing system | Ready to use dispensing system | Ready to use dispensing system | DiaFil & DIAFIL CAPSULE: Same<br>DiaPlus : Same<br>DiaEtch : Same | | Shelf life | 3 years | 2 years | 2 years | DiaFil & DIAFIL CAPSULE: Same<br>DiaPlus : Same<br>DiaEtch : Same | | Period of Use | Permanent (> 30 d) | Permanent (> 30 d) | -limited (≤24 h) | DiaFil & DIAFIL CAPSULE: Same<br>DiaPlus : Same<br>DiaEtch : Same | | Biocompatibility | Conforming to ISO 10993-1 | Conforming to ISO 10993-1 | Conforming to ISO 10993-1 | DiaFil & DIAFIL CAPSULE: Same<br>DiaPlus : Same<br>DiaEtch : Same | | Performance<br>Standard<br>conformance | Meet ISO 4049 standard | Meet ISO 4049 standard | Meet ISO 4049 standard | DiaFil & DIAFIL CAPSULE: Same<br>DiaPlus : Same<br>DiaEtch : Same | CONFIDENTIAL {7}------------------------------------------------ # 510k SUBMISSION ## Diadent Group International # Product Name : DIAFIL & DIAFIL CAPSULE CONFIDENTIAL Pages 5 of 6 {8}------------------------------------------------ ## 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