← Product Code [EBC](/productcode/EBC) · K260819 # Any-Com Seal (K260819) _Mediclus Co., Ltd. · EBC · May 1, 2026 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K260819 ## Device Facts - **Applicant:** Mediclus Co., Ltd. - **Product Code:** [EBC](/productcode/EBC.md) - **Decision Date:** May 1, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3765 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Indications for Use Any-Com Seal is indicated for prophylactic sealing of pits and fissures as well as for micro-restorative procedures for composite restorations. ## Device Story Any-Com Seal is a light-cured, resin-based pit and fissure sealant; contains fluoride-releasing micro-hybrid fillers. Applied by licensed dental professionals in a clinical setting to tooth surfaces; polymerized using a dental curing unit to form a hardened, protective barrier against dental caries. Output is a physical sealant layer; aids in caries prevention and micro-restoration of composite materials. ## Clinical Evidence Bench testing only. Performance evaluated per ISO 4049 and ISO 6874, including depth of cure, film thickness, water sorption, solubility, and fluorine release. Biocompatibility testing conducted per ISO 10993-1, -5, -10, -11, and -23. ## Technological Characteristics Resin-based matrix (Bis-GMA, TEGDMA, UDMA) with fluoride-releasing micro-hybrid fillers. Light-cured polymerization. Complies with ISO 4049 and ISO 6874. Delivered via syringe with disposable tips. Permanent duration of use. ## Regulatory Identification A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities. ## Predicate Devices - Parkell Pit and Fissure Sealant ([K243254](/device/K243254.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FDA U.S. FOOD & DRUG ADMINISTRATION May 1, 2026 Mediclus Co., Ltd. Ku Da Hyeon RA Associate # 1210, 134, Gongdan-Ro, Heungdeok-Gu Cheongju-Si, 28576 Republic Of Korea Re: K260819 Trade/Device Name: Any-Com Seal Regulation Number: 21 CFR 872.3765 Regulation Name: Pit And Fissure Sealant And Conditioner Regulatory Class: Class II Product Code: EBC Dated: March 13, 2026 Received: March 13, 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. 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" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K260819 - Ku Da Hyeon Page 2 (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-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). {2} K260819 - Ku Da Hyeon Page 3 Sincerely, ![img-0.jpeg](img-0.jpeg) Bobak Shirmohammad i-S For Michael E. Adjodha, M.ChE., 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} FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF | 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) K260819 | | | Device Name Any-Com Seal | | | Indications for Use (Describe) It is indicated for prophylactic sealing of pits and fissures as well as for micro-restorative procedures for composite 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) | | | 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." | | {4} K260819 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: March 13, 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: Any-Com Seal - Common Name: Light-cured Pit & Fissure Sealant - Classification Name: Dental Sealant, Pit and Fissure - Product Code: EBC - Classification regulation: 21 CFR 872.3765 ## 4. Predicate Device: Parkell Pit and Fissure Sealant by Parkell, Inc. (K243254) ## 5. Description: 510(k) summary {5} 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 Any-Com Seal is a light-cured pit and fissure sealant intended for sealing pits and fissures on tooth surfaces to help prevent dental caries. The material consists of a resin-based matrix containing fluoride-releasing micro-hybrid fillers. Upon exposure to visible light from a dental curing unit, the material polymerizes to form a hardened sealant layer that adheres to the tooth surface. The cured material provides a protective barrier over pits and fissures. ## 6. Indication for use: Any-Com Seal is indicated for prophylactic sealing of pits and fissures as well as for micro-restorative procedures for composite restorations. ## 7. Basis for Substantial Equivalence ### 7.1. Comparison Chart | | | Subject Device | Predicate Device | Equivalence evaluation | | --- | --- | --- | --- | --- | | Manufacturer | | MEDICLUS Co., Ltd. | Parkell Pit and Fissure Sealant | - | | Product Name | | Any-Com Seal | Parkell, Inc. | - | | 510k# | | - | K243254 | - | | Product Code | | EBC | EBC | - | | Material | | Bis-GMA, TEGDMA, UDMA, etc.. | Fluoride Calcium phosphate | Similar | | Curing type | | Ligh-curing | Ligh-curing | Same | | Indications for Use Statement | | Any-Com Seal is indicated for prophylactic sealing of pits and fissures as well as for micro-restorative procedures for composite restorations. | Parkell Pit and Fissure Sealant is indicated for prophylactic sealing of pits and fissures as well as for micro-restorative procedures for composite restorations. | Same | | Intended User | | Licensed Dentist or Dental Professional | Licensed Dentist or Dental Professional | Same | | Technological Characteristics | Standard | ISO 4049 and ISO 6874 | ISO 4049 and ISO 6874 | Similar | | | Depth of cure | ≥1.5mm | 1.5-2.5mm | | | | Film thickness | ≤50 μm | - | | | | Water sorption | ≤40 μg/mm³ | - | | | | Solubility | ≤7.5 μg/mm³ | - | | 510(k) summary {6} 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 | Biocompatibility | Biocompatible | Biocompatible | Same | | --- | --- | --- | --- | | Delivery method | • Delivery System: Syringe • Weight: 1.2ml • Disposable tip | • Delivery System: Syringe • Weight: 1.2ml • Applicator tip | Similar | | Period of Use | Permanent | Permanent | Same | | Shelf-Life | 2 years | 2 years | Same | ## 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, Weight, Packaging, Depth of cure, Film thickness, Water sorption, Solubility, Sensitivity to ambient light, Fluorine release 7 days in accordance with ISO 4049, ISO 6874. - 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 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 --- **Source:** [https://fda.innolitics.com/device/K260819](https://fda.innolitics.com/device/K260819) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com