Dia-X Sil Heavy Body

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION September 16, 2026 DiaDent Group International Jin An RA team 16, Osongsaengmyeong 4-Ro, Osong-Eup, Heungdeok-Gu Cheongju-Si, 28186 REPUBLIC OF KOREA Re: K254142 Trade/Device Name: Dia-X Sil Heavy Body Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: Class II Product Code: ELW Dated: August 18, 2026 Received: August 18, 2026 Dear Jin An: 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} K254142 - Jin An 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} K254142 - Jin An 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} # 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. | K254142 | ? | | --- | --- | --- | | Please provide the device trade name(s). | | ? | | Dia-X Sil Heavy Body | | | | Please provide your Indications for Use below. | | ? | | - Crown and bridge impressions - Inlay and onlay impressions - Functional impressions - Implant impressions - Denture and partial denture impressions | | | | 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} DiaDent Group International Product Name: Dia-X Sil Heavy Body # 510(k) Summary This summary of 510(k) substantial equivalence information is submitted in accordance with the requirements of 21 CFR 807.92. # 1. Application Information | 510(k) Number | K254142 | | --- | --- | | Date Prepared | Aug 18, 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 | Byung Chul Kim Quality Assurance Manager Phone: +82-43-266-2315 FAX: +82-43-235-2315 Email: diadent68@diadent.co.kr | # 2. Device Information | Common Name | Dental Impression Material | | --- | --- | | Classification Name | Material, Impression | | Regulation Description | Impression material | | Review Panel | Dental | | Regulation Number | 21 CFR 872.3660 | | Product Code | ELW | | Device Class | II | | Device Trade Name | Dia-X Sil Heavy Body | # 3. Predicate Device | | Primary Predicate Device | Predicate Device | | --- | --- | --- | | 510(k) Number | K214086 | K223892 | | Applicant | Genoss Co.,Ltd. | Innovative Product Brands, Inc. | | Device Name | Bright Impress-Heavy | DentMix VPS Impression Material | | Regulation Number | 21 CFR 872.3660 | 21 CFR 872.3660 | | Product Code | ELW | ELW | | Device Class | II | II | # 4. Device Description Dia-X Sil Heavy Body is a vinyl polysiloxane (VPS) impression material designed for impression taking. It complies with ISO 4823 standards and is classified as Type 1. | No. | Model Name | Composition | | --- | --- | --- | | 1 | Dia-X Sil Heavy Body A Type | Dia-X Sil Heavy Body 50ml Cartridge 1ea | | 2 | Dia-X Sil Heavy Body C Type | Dia-X Sil Heavy Body 50ml Cartridge 2ea | Page 1 {5} DiaDent Group International Product Name: Dia-X Sil Heavy Body | 3 | Dia-X Sil Heavy Body E Type | Dia-X Sil Heavy Body 50ml Cartridge 4ea | | --- | --- | --- | | 4 | Dia-X Sil Heavy Body G type | Dia-X Sil Heavy Body 50ml Cartridge 10ea | | 5 | Dia-X Sil Heavy Body I type | Dia-X Sil Heavy Body 50ml Cartridge 24ea | | 6 | Dia-X Sil Heavy Body Sample | Dia-X Sil Heavy Body 25ml Cartridge 1ea | ### 5. Indications for Use - Crown and bridge impressions - Inlay and onlay impressions - Functional impressions - Implant impressions - Denture and partial denture impressions ### 6. Technological Characteristics The subject device, Dia-X Sil Heavy Body has similar characteristics to the primary predicate device, Bright Impress-Heavy, DentMix VPS Impression Material. [Comparison table] | | Subject Device | Primary Predicate Device | Predicate Device | Discuss | | --- | --- | --- | --- | --- | | 510(k) Number | K254142 | K214086 | K223892 | - | | Product Code | ELW | ELW | ELW | Equivalent | | Device Class | II | II | II | Equivalent | | Manufacturer | DiaDent Group International | Genoss Co.,Ltd. | Innovative Product Brands, Inc. | - | | Device Name | Dia-X Sil Heavy Body | Bright Impress-Heavy | DentMix VPS Impression Material | - | | Indications for Use | -Crown and bridge impressions-Inlay and onlay impressions-Functional impressions-Implant impressions-Denture and partial denture impressions | Impression of inlay, onlay crown, and bridge preparation-Crown, bridge impression-Inlay and onlay impression-Functional impression-Denture impression-Study model impression | DentMix VPS Impression Material is intended for use with all crown and bridge, occlusal and implant impression techniques to reproduce the structure of a patient's teeth and gums. | Equivalent | | Raw Materials | - Siloxanes and Silicones, di-Me Vinyl Group-Terminated-Silica-Silicone Polyethercopolymer | - Polyvinyl Siloxane | - Vinyl Polysiloxane-Filler-Pigments | * See the below table. | Page 2 {6} DiaDent Group International Product Name: Dia-X Sil Heavy Body | | - Siloxanes and Silicones, Di-ME, Me Hydrogen - Platinum, 1,3-diethenyl 1,1,3,3 tetramethyldisiloxane complexes | | | | | --- | --- | --- | --- | --- | | Description | Dia-X Sil Heavy Body is a vinyl polysiloxane (VPS) impression material designed for impression taking. It complies with ISO 4823 standards and is classified as Type 1. | Bright Impress impression material is a fast-set of addition-reaction silicone elastomer (Vinyl polysiloxane)-based material for dental professionals, consisting of five types (Light, Medium, Heavy, Bite and Putty) with superior hydrophilicity, dimensional accuracy, high tensile strength, and resistant to deformation. It is designed for versatile impression techniques of crowns, bridges, orthodontics and implants. | DentMix VPS Impression Material is an addition-reaction base/catalyst polyvinylsiloxane dental impression material intended as an alternative to traditional alginate materials. It is available in regular set and fast set. Both are available in light body, regular body/monophase and heavy body. | Similarity | | Performance Standard Conformance | ISO 4823 | ISO 4823 | ISO 4823 | Equivalent | | Physical and Mechanical properties | - Consistency: < 35mm - Detail reproduction: 50μm line - Linear dimensional change: < 1.5% - Compatibility with gypsum: 50μm line - Elastic Recovery: > 96.5% - Strain in compression: 0.8% to 20% | - Consistency: ≤ 35mm - Detail Reproduction: 50 μm reproduction without interruption - Compatibility with gypsum: 50 μm reproduction without interruption - Elastic Recovery: ≥ 96.5% - Strain in compression: 0.8~20% | - Consistency: 32mm - Linear Dimensional Change: 0.14% - Compatibility with Gypsum: Pass - Elastic Recovery: 99.1% - Strain in compression: 2.54% | Equivalent | | Handling System | Two part base/catalyst system | Two part base/catalyst system | Two part base/catalyst system | Equivalent | | Biocompatibility | Biocompatible | Biocompatible | Biocompatible | Equivalent | | Sterility | Non-sterile | Non-sterile | Non-sterile | Equivalent | Page 3 {7} DiaDent Group International Product Name: Dia-X Sil Heavy Body * Difference table | Subject Device | Predicate Device | Predicate Device | Discussion | | --- | --- | --- | --- | | - Siloxanes and Silicones, di-Me Vinyl group-Terminated- Silica- Silicone Polyethercopolymer- Siloxanes and Silicones, Di-ME, Me Hydrogen- Platinum, 1,3-diethenyl 1,1,3,3 tetramethyldisiloxane complexes | - Polyvinyl Siloxane | - Vinyl Polysiloxane- Filler- Pigments | Both the Subject Device and the Predicate Devices contain Polyvinyl Siloxane as the primary chemical constituent. These differences have been evaluated through biocompatibility testing and do not raise any new issues of safety or effectiveness. | ### 7. Non-Clinical Performance Data The performance and biological tests were conducted on the subject device; Dia-X Sil Heavy Body according to the following standards. ISO 4823:2021, Dentistry — Elastomeric impression and bite registration 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 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity ISO 10993-10:2021, Biological evaluation of medical devices - Part 10: Tests for skin sensitization ISO 10993-23:2021, Biological evaluation of medical devices - Part 23: Tests for irritation #### Performance Testing (Bench Testing) To demonstrate the physical properties of the subject device, the following specific bench tests were performed in accordance with ISO 4823:2021: | Item | Requirement | Pass/Fail | | --- | --- | --- | | Working-time | At least 1 minute | Pass | | Consistency | Within 35mm or less | Pass | | Detail reproduction | The 50μm line without interruption | Pass | | Linear dimensional change | 1.5% or less | Pass | | Compatibility with gypsum | The 50μm line without interruption | Pass | | Elastic recovery | At least 96.5% | Pass | | Strain in compression | Within the range of 0.8% to 20.0% | Pass | #### Biocompatibility Testing To demonstrate the biological safety of the subject device, the following specific biocompatibility tests were performed: Page 4 {8} DiaDent Group International Product Name: Dia-X Sil Heavy Body | Item | Standard | | --- | --- | | In vitro Cytotoxicity | ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | | Skin Sensitization | ISO 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for skin sensitization | | Oral Mucosa Irritation | ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation | The test results demonstrated that the subject device, Dia-X Sil Heavy Body, met all the acceptance criteria of the applicable standards and performed as intended. ### 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 5