One-Fil LC

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION July 21, 2026 Mediclus Co., Ltd. Ku Da Hyeon Official Correspondent # 1210, 134, Gongdan-Ro, Heungdeok-Gu Cheongju-Si, 28576 REPUBLIC OF KOREA Re: K261728 Trade/Device Name: One-Fil LC Regulation Number: 21 CFR 872.3250 Regulation Name: Calcium hydroxide cavity liner Regulatory Class: Class II Product Code: EJK Dated: May 26, 2026 Received: May 26, 2026 Dear Ku Da Hyeon: 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} K261728 - Ku Da Hyeon 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 13484 clause 8.3 (Nonconforming product), and ISO 13485 clause 8.5 (Corrective and 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 21 CFR 820.70) and document changes and approvals in the Medical Device File (21 CFR 820.181). 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} K261728 - Ku Da Hyeon 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 # **Indications for Use** Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 510(k) Number (if known) K261728 Device Name One-Fil LC Indications for Use (Describe) One-Fil LC is indicated for lining and basing applications under dental restorations. One-Fil LC is also indicated for direct pulp capping. 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} K261728 MEDICLUS® E. sales@mdclus.com T. +82-43-211-2877 F. +82-43-211-2866 Contact: Lydia www.mediclus.co.kr (Headquarters) No. 1210, 134 Gongdan-ro, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do 28576, Korea (Seoul Office) 206 Brown Stone, 464 Cheongpa-ro, Jung-gu, Seoul 04510, Korea ## 510(k) Summary This summary of 510(K) information is being submitted in accordance with requirements of 21 CFR Part 807.92. Date: May 22, 2025 ### 1. Submitter/Contact Person Da-Hyeon, Ku MEDICLUS Co., Ltd. No. 1210, 134, Gongdan-ro, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, Republic of Korea TEL: +82(43)211-2877 FAX: +82(43)211-2866 Email: ra@mdclus.com ### 2. U.S Agent Priscilla Chung LK Consulting Group USA, Inc. 18881 Von Karman Ave STE 160, Irvine CA 92612 Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com ### 3. Device - Trade Name: One-Fil LC - Common Name: Cavity Liner/Base - Classification Name: Liner/base, Dental Cement - Product Code: EMA - Classification regulation: 21 CFR 872.3275 ### 4. Predicate Device: 3M VitCal Liner/Base by 3M ESPE Dental Products. (K230270) ### 5. Description: 510(k) summary 1 / 4 page {5} MEDICLUS® E. sales@medclus.com T. +82-43-211-2877 F. +82-43-211-2866 Contact. Lydia www.mediclus.co.kr (Headquarters) No. 1210, 134 Gongdan-ro, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do 28576, Korea (Seoul Office) 206 Brown Stone, 464 Cheongpa-ro, Jung-gu, Seoul 04510, Korea One-Fil LC is a light-cured, calcium silicate-based pulp protectant and cavity liner intended for use in restorative dental procedures. The device is applied to dentin surfaces in deep cavities, including areas in close proximity to the pulp or small pulpal exposures, prior to placement of restorative materials. The device contains calcium silicate and bioactive glass components. Following placement, the material releases calcium and hydroxyl ions and forms a physical barrier layer at the cavity interface. The device is intended to protect the pulpal area and provide insulation between the tooth structure and overlying restorative materials. # 6. Indication for use: One-Fil LC is indicated for lining and basing applications under dental restorations. One-Fil LC is also indicated for direct pulp capping. # 7. Basis for Substantial Equivalence # 7.1. Comparison Chart | | | Subject Device | Predicate Device | Equivalence evaluation | | --- | --- | --- | --- | --- | | **Manufacturer** | | MEDICLUS Co., Ltd. | 3M ESPE | - | | **Product Name** | | One-Fil LC | 3M VitCal Liner/Base | - | | **510k#** | | - | K230270 | - | | **Product Code** | | EMA | EMA | - | | **Material** | | Calcium silicate, Bioglass, Bis-GMA, PEGDMA | Portland cement, Silane-treated silica, Methacrylate polymer, photoinitiators | Similar | | **Curing type** | | Light-curing | Ligh-curing | Same | | **Indications for Use Statement** | | One-Fil LC is indicated for lining and basing applications under dental restorations. One-Fil LC is also indicated for direct pulp capping. | 3M VitCal Liner/Base is indicated for lining and basing applications under dental restorations. 3M VitCal Liner/Base is also indicated for direct pulp capping. | Same | | **Intended User** | | Licensed Dentist or Dental Professional | Licensed Dentist or Dental Professional | Same | | **Technological** | **Standard** | ISO 4049 and ISO 6876 | ISO 4049 and ISO 6874 | Similar | | | **Depth of cure** | ≥ 1.0 mm | - | | 510(k) summary 2 / 4 page {6} MEDICLUS® E. sales@medclus.com T. +82-43-211-2877 F. +82-43-211-2866 Contact. Lydia www.mediclus.co.kr (Headquarters) No. 1210, 134 Gongdan-ro, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do 28576, Korea (Seoul Office) 206 Brown Stone, 464 Cheongpa-ro, Jung-gu, Seoul 04510, Korea | Characteristics | Film thickness | ≤ 50 μm | - | | | --- | --- | --- | --- | --- | | | Flexural strength | ≥ 10 MPa | > 10 MPa | | | | Calcium release | ≥ 100 ppm | > 0 μg/g | | | Biocompatibility | | Biocompatible | Biocompatible | Same | | Dispensing System | | Intra-oral, syringe with single-use tips | Intra-oral, multi-nuit micro-mix syringe with single-use tips | Similar | | Period of Use | | Permanent | Permanent | Same | | Shelf-Life | | 2 years | 3 years | Similar | # 7.2. Comparison Chart The subject device has the same indications for use and the technological characteristics as the predicate device. The minor raw materials are different between the devices but the performance and the biocompatibility test results show that it does not raise a concern in safety and effectiveness. # 8. Non-Clinical Testing - Performance Tests including - Appearance, Volume, Packaging, Sensitivity to the light, Color stability, Depth of cure, Radio-opacity, Film thickness, Flowability, Flexural strength, pH, Calcium release amount (10 days) in accordance with ISO 4049, ISO 6876. - Biocompatibility Tests - ISO 10993-1 Biological evaluation of medical devise - Part 1: Evaluation and testing within a risk management process - ISO 10993-5:2009, Tests for in vitro cytotoxicity - ISO 10993-23:2021, Tests for irritation - ISO 10993-10:2021, Tests for skin sensitization - ISO 10993-11:2017, Tests for systemic toxicity # 9. Conclusion 510(k) summary 3 / 4 page {7} MEDICLUS® E. sales@medclus.com T. +82-43-211-2877 F. +82-43-211-2866 Contact: Lydia www.mediclus.co.kr (Headquarters) No. 1210, 134 Gongdan-ro, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do 28576, Korea (Seoul Office) 206 Brown Stone, 464 Cheongpa-ro, Jung-gu, Seoul 04510, Korea The subject device and the predicate device have the same intended use and have the same technological characteristics. Based on the similarities and the test results, we conclude that the subject device is substantially equivalent to the predicate device. 510(k) summary 4 / 4 page