DIAFIL

{0} **FDA** **U.S. FOOD & DRUG** ADMINISTRATION June 2, 2026 DiaDent Group International Seung-Geun Lee Regulatory Affairs Manager 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, 28161 REPUBLIC OF KOREA Re: K261093 Trade/Device Name: DIAFIL Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: April 2, 2026 Received: April 6, 2026 Dear Seung-Geun 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 (the 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 available 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K261093 - Seung-Geun Lee Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory- {2} K261093 - Seung-Geun Lee Page 3 assistance/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 -S** Michael E. Adjodha, MChE, RAC, CQIA 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 {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. # Indications for Use 510(k) Number (if known) K261093 Device Name DIAFIL Indications for Use (Describe) 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 - Core build-ups - Splinting 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) 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." FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {4} K261093 DiaDent Group International^{}[] Product Name: DIAFIL # 510(k) Summary This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92. ## 1. Application Information | Date Prepared | Apr 02, 2026 | | --- | --- | | Company Name and Address | DiaDent Group International 16, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, 28161, Republic of Korea | | Contact Person | Seung-Geun Lee Regulatory Affairs Manager Phone: +82-43-266-2315 FAX: +82-43-235-2315 Email: diadent33@diadent.co.kr | ## 2. Device Information | Device Type | Material, Tooth Shade, Resin | | --- | --- | | Regulation Description | Tooth shade resin material | | Review Panel | Dental | | Regulation Number | 21 CFR 872.3690 | | Product Code | EBF | | Device Class | II | | Device Name | DIAFIL | ## 3. Primary Predicate Device | 510(k) Number | K192510 | | --- | --- | | Applicant | DiaDent Group International | | Device Name | DIAFIL & DIAFIL Capsule | | Regulation Number | 21 CFR 872.3690 | | Product Code | EBF | | Device Class | II | ## 4. Device Description DIAFIL is a composite dental resin for aesthetic restoration corresponding to Type 1, Class 2 and Group 1 of ISO 4049:2019 and is used in direct restoration of cavity by being polymerized in oral cavity. | No. | Model Name | Composition | | --- | --- | --- | | 1 | DIAFIL A1 Refill Package | DIAFIL A1 4g Syringe 1ea | | 2 | DIAFIL A2 Refill Package | DIAFIL A2 4g Syringe 1ea | | 3 | DIAFIL A3 Refill Package | DIAFIL A3 4g Syringe 1ea | Page 1 {5} # **DiaDent Group International** **Product Name: DIAFIL** | 4 | DIAFIL A3.5 Refill Package | DIAFIL A3.5 4g Syringe 1ea | | --- | --- | --- | | 5 | DIAFIL A4 Refill Package | DIAFIL A4 4g Syringe 1ea | | 6 | DIAFIL B1 Refill Package | DIAFIL B1 4g Syringe 1ea | | 7 | DIAFIL B2 Refill Package | DIAFIL B2 4g Syringe 1ea | | 8 | DIAFIL B3 Refill Package | DIAFIL B3 4g Syringe 1ea | | 9 | DIAFIL B4 Refill Package | DIAFIL B4 4g Syringe 1ea | | 10 | DIAFIL C1 Refill Package | DIAFIL C1 4g Syringe 1ea | | 11 | DIAFIL C2 Refill Package | DIAFIL C2 4g Syringe 1ea | | 12 | DIAFIL C3 Refill Package | DIAFIL C3 4g Syringe 1ea | | 13 | DIAFIL C4 Refill Package | DIAFIL C4 4g Syringe 1ea | | 14 | DIAFIL D1 Refill Package | DIAFIL D1 4g Syringe 1ea | | 15 | DIAFIL D2 Refill Package | DIAFIL D2 4g Syringe 1ea | | 16 | DIAFIL D3 Refill Package | DIAFIL D3 4g Syringe 1ea | | 17 | DIAFIL D4 Refill Package | DIAFIL D4 4g Syringe 1ea | | 18 | DIAFIL CL Refill Package | DIAFIL CL 4g Syringe 1ea | | 19 | DIAFIL A1 Intro Kit | DIAFIL A1 1g Syringe 1ea | | 20 | DIAFIL A2 Intro Kit | DIAFIL A2 1g Syringe 1ea | | 21 | DIAFIL A3 Intro Kit | DIAFIL A3 1g Syringe 1ea | | 22 | DIAFIL A3.5 Intro Kit | DIAFIL A3.5 1g Syringe 1ea | | 23 | DIAFIL A4 Intro Kit | DIAFIL A4 1g Syringe 1ea | | 24 | DIAFIL B1 Intro Kit | DIAFIL B1 1g Syringe 1ea | | 25 | DIAFIL B2 Intro Kit | DIAFIL B2 1g Syringe 1ea | | 26 | DIAFIL B3 Intro Kit | DIAFIL B3 1g Syringe 1ea | | 27 | DIAFIL B4 Intro Kit | DIAFIL B4 1g Syringe 1ea | | 28 | DIAFIL C1 Intro Kit | DIAFIL C1 1g Syringe 1ea | | 29 | DIAFIL C2 Intro Kit | DIAFIL C2 1g Syringe 1ea | Page 2 {6} DiaDent Group International Product Name: DIAFIL | 30 | DIAFIL C3_Intro Kit | DIAFIL C3 1g Syringe 1ea | | --- | --- | --- | | 31 | DIAFIL C4_Intro Kit | DIAFIL C4 1g Syringe 1ea | | 32 | DIAFIL D1_Intro Kit | DIAFIL D1 1g Syringe 1ea | | 33 | DIAFIL D2_Intro Kit | DIAFIL D2 1g Syringe 1ea | | 34 | DIAFIL D3_Intro Kit | DIAFIL D3 1g Syringe 1ea | | 35 | DIAFIL D4_Intro Kit | DIAFIL D4 1g Syringe 1ea | | 36 | DIAFIL CL_Intro Kit | DIAFIL CL 1g Syringe 1ea | | 37 | DIAFIL Capsule Type A1 | DIAFIL A1 0.25g Capsule Type 20ea | | 38 | DIAFIL Capsule Type A2 | DIAFIL A2 0.25g Capsule Type 20ea | | 39 | DIAFIL Capsule Type A3 | DIAFIL A3 0.25g Capsule Type 20ea | | 40 | DIAFIL Capsule Type A3.5 | DIAFIL A3.5 0.25g Capsule Type 20ea | | 41 | DIAFIL Capsule Type A4 | DIAFIL A4 0.25g Capsule Type 20ea | | 42 | DIAFIL Capsule Type B1 | DIAFIL B1 0.25g Capsule Type 20ea | | 43 | DIAFIL Capsule Type B2 | DIAFIL B2 0.25g Capsule Type 20ea | | 44 | DIAFIL Capsule Type B3 | DIAFIL B3 0.25g Capsule Type 20ea | | 45 | DIAFIL Capsule Type B4 | DIAFIL B4 0.25g Capsule Type 20ea | | 46 | DIAFIL Capsule Type C1 | DIAFIL C1 0.25g Capsule Type 20ea | | 47 | DIAFIL Capsule Type C2 | DIAFIL C2 0.25g Capsule Type 20ea | | 48 | DIAFIL Capsule Type C3 | DIAFIL C3 0.25g Capsule Type 20ea | | 49 | DIAFIL Capsule Type C4 | DIAFIL C4 0.25g Capsule Type 20ea | | 50 | DIAFIL Capsule Type D1 | DIAFIL D1 0.25g Capsule Type 20ea | | 51 | DIAFIL Capsule Type D2 | DIAFIL D2 0.25g Capsule Type 20ea | | 52 | DIAFIL Capsule Type D3 | DIAFIL D3 0.25g Capsule Type 20ea | | 53 | DIAFIL Capsule Type D4 | DIAFIL D4 0.25g Capsule Type 20ea | | 54 | DIAFIL Capsule Type CL | DIAFIL CL 0.25g Capsule Type 20ea | Page 3 {7} DiaDent Group International Product Name: DIAFIL ### 5. 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 -. Core build-ups -. Splinting ### 6. Technological Characteristics The subject device, DIAFIL has similar characteristics to the primary predicate device, DIAFIL & DIAFIL Capsule. [Comparison table] | | Subject Device | Predicate Device | Discuss | | --- | --- | --- | --- | | 510(k) Number | - | K192510 | - | | Product Code | EBF | EBF | Equivalent | | Device Class | II | II | Equivalent | | Manufacturer | DiaDent Group International | DiaDent Group International | - | | Device Name | DIAFIL | DIAFIL & DIAFIL Capsule | - | | 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 -. Core build-ups -. Splinting | 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 | Equivalent | | Raw Materials | -Urethane dimethacrylate -Bisphenol A glycidyl methacrylate Triethylene glycol dimethacrylate -Trimethylolpropane trimethacrylate - BYK-405 - Barium glass powder - Barium glass powder - SiO2 - Camphorquinone -Ethyl-4-(Dimethylamino)benzoate(EDB) - Dibutyl hydroxy toluene (BHT) | - Bisphenol A epoxymethacrylate/Triethyleneglycol dimethacrylate - Triethyleneglycol dimethacrylate - Urethane dimethacrylate - Ethoxylated Bisphenol A dimethacrylate - Glass Composition - Pyrogenic colloidal silica treated with 3-methacryloxy propyl trimethoxy silane - D,L-Camphorquinone - Ethyl 4-dimethylaminobenzoate | * See the below table. | Page 4 {8} DiaDent Group International Product Name: DIAFIL | | - 2-hydroxy-4-(octyloxy)benzophenone | -2-Hydroxy-4-n-octoxybenzophenone -2,6-di-tert-butyl-p-cresol -4-Methoxyphenol | | | --- | --- | --- | --- | | Principle of operation | light-cured restorative composite resin and accessories for use in both posterior and anterior restoration. | light-cured restorative hybrid composite resin and accessories for use in both posterior and anterior restoration. | Equivalent | | Performance Standard Conformance | Conformed ISO 4049 | Conformed ISO 4049 | Equivalent | | Physical and Mechanical properties | -. Water sorption -. Solubility -. Depth of cure -. Flexural strength -. Radiopacity | -. Water sorption -. Solubility -. Depth of cure -. Flexural strength -. Radiopacity | Equivalent | | Biocompatibility | Biocompatible | Biocompatible | Equivalent | | Use | Prescription / Hospital | Prescription / Hospital | Equivalent | | Period of use | Permanent | Permanent | Equivalent | | Sterility | Non-sterile | Non-sterile | Equivalent | | Shelf-life | 3 years | 3 years | Equivalent | * Difference table | Subject Device | Predicate Device | Discussion | | --- | --- | --- | | -Urethane dimethacrylate -Bisphenol A glycidyl methacrylate Triethylene glycol dimethacrylate -Trimethylolpropane trimethacrylate - BYK-405 - Barium glass powder - Barium glass powder - SiO2 - Camphorquinone -Ethyl-4-(Dimethylamino)benzoate(EDB) - Dibutyl hydroxy toluene (BHT) - 2-hydroxy-4-(octyloxy)benzophenone | - Bisphenol A epoxymethacrylate/Triethyleneglycol dimethacrylate - Triethyleneglycol dimethacrylate - Urethane dimethacrylate - Ethoxylated Bisphenol A dimethacrylate - Glass Composition - Pyrogenic colloidal silica treated with 3-methacryloxy propyl trimethoxy silane - D,L-Camphorquinone - Ethyl 4-dimethylaminobenzoate -2-Hydroxy-4-n-octoxybenzophenone -2,6-di-tert-butyl-p-cresol -4-Methoxyphenol | The main raw material, Bis-GMA (Bisphenol A-Glycidyl Methacrylate), used in the subject device is the same as that used in the predicate device. The biocompatibility test results demonstrate that this material does not raise any safety or effectiveness concerns. | Page 5 {9} **DiaDent Group International** **Product Name: DIAFIL** ## **7. Non-Clinical Performance Data** The performance and biological tests were conducted on the subject device; DIAFIL according to the following standards. ISO 4049:2019, Dentistry — Polymer-based restorative materials ISO 7405:2018, Dentistry — Evaluation of biocompatibility of medical devices used in dentistry ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process ISO 10993-3:2014, Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity ISO 10993-10:2010, Biological evaluation of medical devices - Part 10: Tests for skin sensitization ISO 10993-11:2017, Biological evaluation of medical devices - Part 11: Tests for systemic toxicity ISO 10993-23:2021, Biological evaluation of medical devices - Part 23: Tests for irritation The test results corresponded the requirements of standards. Therefore, the subject device is substantially equivalent in safety and effectiveness to the predicate device. ## **8. Clinical Performance Data** No clinical data was collected or provided to support substantial equivalence between the subject and predicate device. ## **9. Conclusions** Based on the above information and all data provided in this submission, the subject device is substantially equivalent to the legally marketed device identified in this submission. Page 6