← Product Code [EMA](/productcode/EMA) · K254201 # Any-Cem (K254201) _Mediclus Co., Ltd. · EMA · Aug 13, 2026 · Dental · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K254201 ## Device Facts - **Applicant:** Mediclus Co., Ltd. - **Product Code:** [EMA](/productcode/EMA.md) - **Decision Date:** Aug 13, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3275 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Indications for Use Metal crowns, bridges, inlays and onlays Resin crowns, bridges, inlays and onlays All ceramic ## Device Story Any-Cem is a radiopaque, dual-cured (self-cure or light-cure) dental resin-based cement. Used by licensed dentists in clinical settings for permanent cementation of indirect restorations including crowns, bridges, inlays, and onlays. Supplied in syringes with automix tips; applied by the clinician to the restoration or tooth surface. The material provides high bonding strength to various restorative materials while allowing for easy removal of excess cement. Benefits include secure, long-term fixation of dental prosthetics. ## Clinical Evidence No clinical data. Bench testing only. Performance testing included appearance, weight, packaging, color stability, film thickness, working/setting time, flexural strength, water sorption, solubility, radiopacity, bond strength, and dental tubule blocking efficacy per ISO 4049 and ISO 29022. Biocompatibility testing included cytotoxicity (ISO 7405), irritation (ISO 10993-23), acute systemic toxicity (ISO 10993-11), and skin sensitization (ISO 10993-10). All results met specified requirements. ## Technological Characteristics Resin-based dental cement containing Bisphenol A glycerolate dimethacrylate, 2-Hydroxyethyl methacrylate, Barium glass, Camphorquinone, 2,6-di-tert-butyl-p-cresol, and pigments. Dual-cured (self/light). Radiopaque. Complies with ISO 4049 and ISO 29022. Delivered via syringe with automix tips. Permanent use. ## Regulatory Identification Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. ## Predicate Devices - Dia-Cem by DiaDent Group International ([K231552](/device/K231552.md)) ## Reference Devices - MAXCEM 2 by Kerr Corporation ([K073209](/device/K073209.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 August 13, 2026 Mediclus Co., Ltd. Ku Da Hyeon RA Associate # 1210, 134, Gongdan-Ro, Heungdeok-Gu Cheongju-Si, 28576 Republic Of Korea Re: K254201 Trade/Device Name: Any-Cem Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: Class II Product Code: EMA Dated: July 21, 2026 Received: July 21, 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} K254201 - 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} K254201 - Ku Da Hyeon Page 3 Sincerely, ![img-0.jpeg](img-0.jpeg) 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} # Indications for Use | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K254201 | ? | | --- | --- | --- | | Please provide the device trade name(s). | | ? | | Any-Cem | | | | Please provide your Indications for Use below. | | ? | | - Metal crowns, bridges, inlays and onlays - Resin crowns, bridges, inlays and onlays - All ceramic | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | {4} K254201 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: August 12, 2026 ### 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-Cem - Common Name: Dental Resin-based Cement - Classification Name: Dental Cement - Product Code: EMA - Classification regulation: 21 CFR 872.3275 ### 4. Comparison Devices - Primary Predicate Device: Dia-Cem by DiaDent Group International (K231552) - Reference Device: MAXCEM 2 by Kerr Corporation (K073209) - K073209 was included as a reference device to provide additional support for the performance characteristics of the subject device. Comparative testing of water sorption and solubility was conducted between the subject device and Maxcem, which 510(k) summary 1 / 5 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 was cleared under K073209. The comparable results support the substantial equivalence of the subject device with respect to these performance characteristics. # 5. Description: Any-Cem is a dental resin-based cement intended for dental restorations. It is designed for use in restorative dental procedures in accordance with its intended use. It is available in three shades: Universal, White and TL. Any-Cem is a radiopaque resin cement that can be used in self-cure or light-cure mode. It shows high bonding strength on various materials, yet excess material can be easily removed. # 6. Indication for use: Metal crowns, bridges, inlays and onlays Resin crowns, bridges, inlays and onlays All ceramic 510(k) summary 2 / 5 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 # 7. Basis for Substantial Equivalence # 7.1. Comparison Chart | | Subject Device | Predicate Device | Reference Device | Equivalence evaluation | | --- | --- | --- | --- | --- | | Manufacturer | MEDICLUS Co., Ltd. | DiaDent Group International | Kerr Corporation | - | | Product Name | Any-Cem | Dia-Cem | Maxcem 2 | - | | 510k# | - | K231552 | K073209 | - | | Product Code | EMA | EMA | EMA | - | | Material | - Bisphenol A glycerolate dimethacrylate - 2-Hydroxyethyl methacrylate - Brium glass - Camphorquinone - 2,6-di-tert-butyl-pcresol - Pigments | - Ethoxylated bisphenol A dimethacrylate - 10-Methacryloxy decyl dihydrogen phosphate - 2-Hydroxyethyl Methacrylate - Barium glass - (+/-)-Camphorquinone - 2, 6-di-tert-butyl-pcresol - Pigments | - 2-hydroxyethyl methacrylate - 2-hydroxy-1,3-propanediyl bismethacrylate - 7,7,9(or 7,9,9)-trimethyl-4,13-dioxo-3,14-dioxa-5,12- diazahexadecane-1,16-diyl bismethacrylate - Ytterbium trifluorid | Similar | | Curing type | Dual-cured (Self-curing, Ligh-curing) | Dual-cured (Self-curing, Ligh-curing) | Dual-cured (Self-curing, Ligh-curing) | Same | | Indications for Use Statement | - Metal crowns, bridges, inlays and onlays - Resin crowns, bridges, inlays and onlays - All ceramic | - Resin crowns, bridges, inlays and onlays -Glass Ceramic, Porcelain crowns, inlays and onlays (includes alumina and zirconia) -Metal crowns, bridges, inlays and onlays (includes porcelain-fused -to-metal and compositeto-metal) -Metal (prefabricated or cast) and | - Cementation of all indirect restorations including ceramic, resin and metal-based inlays, onlays, crowns, bridges, posts, and veneers. - Cementation of crown restoration to implants. | Same | 510(k) summary 3 / 5 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 | | | fiber posts | | | | | --- | --- | --- | --- | --- | --- | | Intended User | | Licensed Dentist or Dental Professional | Licensed Dentist or Dental Professional | Licensed Dentist or Dental Professional | Same | | Technological Characteristics | Standard | ISO 4049 and ISO 29022 | ISO 4049 and ISO 29022 | ISO 4049 and ISO 29022 | Similar | | | Film thickness | ≤ 50 μm | ≤ 50 μm | - | | | | Working time | ≥ 60 sec | 3 min | - | | | | Setting time | ≤ 10 min | 5 min | - | | | | Flexural strength | ≥ 50 MPa | ≥ 50 MPa | - | | | | Bond strength | ≥ 5 MPa | ≥ 4 MPa | - | | | | Water sorption | ≤ 40 μg/mm² | - | Met specification | Similar | | | Solubility | ≤ 7.5 μg/mm² | - | ≤ 7.5 μg/mm² | | | Biocompatibility | | Biocompatible | Biocompatible | Biocompatible | Same | | Delivery method | | • Delivery System: Syringe • Weight: 6g • Automix tips, Eco-tips | • Delivery System: Syringe • Weight: 9g or 3g • Automix tips, Eco-tips | • Delivery System: Syringe • Weight: 5g • Automix tips, Intraoral tips | Similar | | Period of Use | | Permanent | Permanent | Permanent | Same | | Shelf-Life | | 2 years | 2 years | 18 months | Same | 510(k) summary 4 / 5 page {8} 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 # 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, Sensitivity to ambient light, Colour stability, Film thickness, Working time, Setting time, Flexural strength, Water sorption, Solubility, Radiopacity, Bond strength, Dental tubule blocking efficacy in accordance with ISO 4049, ISO 29022. - Biocompatibility Tests including - ISO 10993-1 Biological evaluation of medical devise – Part 1: Evaluation and testing within a risk management process - Cytotoxicity test - ISO 7405:2018, Dentistry-Evaluation of biocompatibility of medical devices used in dentistry - Irritation test - ISO 10993-23:2021, Tests for irritation - Acute systemic toxicity test - ISO 10993-11:2017, Tests for systemic toxicity - Skin sensitization test - ISO 10993-10:2021, Tests for skin sensitization The test results corresponded the requirements of standards. Therefore, the subject device is substantially equivalent in safety and effectiveness to the predicate device. # 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 5 / 5 page --- **Source:** [https://fda-staging.innolitics.com/device/K254201](https://fda-staging.innolitics.com/device/K254201) **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. 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