DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g)
Device Facts
| Record ID | K261071 |
|---|---|
| Device Name | DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g) |
| Applicant | DiaDent Group International |
| Product Code | EBF · Dental |
| Decision Date | May 19, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3690 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
Base under Class I, II direct restorations - Liner under direct restorative materials - Repair of composite/ceramic veneers - Restorations of small posterior cavities - Undercut block-out - Pit & Fissure sealant
Device Story
DIAFIL Bulk FLOW is a light-curing, aesthetic restorative composite resin; used by dental professionals in clinical settings for direct dental restorations. Input: uncured paste containing dimethacrylate monomers, inorganic fillers, and photoinitiators. Operation: material placed into cavity; polymerized using dental visible light-curing unit; results in hardened, durable restoration. Output: cured dental restorative material. Benefits: provides structural repair and aesthetic restoration of dental caries or damage.
Clinical Evidence
No clinical data provided. Substantial equivalence supported by bench testing and biocompatibility evaluation per ISO 4049, ISO 7405, and ISO 10993 series standards.
Technological Characteristics
Light-curing composite resin; Type 1, Class 2, Group 1 per ISO 4049. Composition: Bisphenol A epoxymethacrylate, TEGDMA, UDMA, Barium glass, Fumed silica, photoinitiators, and pigments. Form factor: syringe-delivered paste. Non-sterile. Permanent duration of use. Polymerization via visible light-curing unit.
Indications for Use
Indicated for use as a base/liner for Class I and II direct restorations, repair of composite/ceramic veneers, restoration of small posterior cavities, undercut block-out, and as a pit and fissure sealant.
Regulatory Classification
Identification
Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.
Predicate Devices
- OMNICHROMA (K173275)
Submission Summary (Full Text)
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FDA U.S. FOOD & DRUG ADMINISTRATION
May 19, 2026
DiaDent Group International
Seung-Geun Lee
Regulatory Affairs Manager
16, Osongsaengmyeong 4-Ro, Osong-Eup, Heungdeok-Gu,
Cheongju-Si, 28186 KOR
Re: K261071
Trade/Device Name: DIAFIL Bulk FLOW (Economic Package); DIAFIL Bulk FLOW (Refill Package); DIAFIL Bulk FLOW (0.5g)
Regulation Number: 21 CFR 872.3690
Regulation Name: Tooth Shade Resin Material
Regulatory Class: Class II
Product Code: EBF
Dated: March 31, 2026
Received: April 2, 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.
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
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K261071 - Seung-Geun Lee
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(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).
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K261071 - Seung-Geun Lee
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Sincerely,
Bobak
Shirmohammadi -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
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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) K261071 | |
| Device Name DIAFIL Bulk FLOW (Economic Package); DIAFIL Bulk FLOW (Refill Package); DIAFIL Bulk FLOW (0.5g) | |
| Indications for Use (Describe) - Base under Class I, II direct restorations - Liner under direct restorative materials - Repair of composite/ceramic veneers - Restorations of small posterior cavities - Undercut block-out - Pit & Fissure sealant | |
| 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." | |
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K261071
DiaDent Group International
Product Name: DIAFIL Bulk FLOW
# 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 | Mar 31, 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-guen 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 Bulk FLOW |
# 3. Primary Predicate Device
| 510(k) Number | K173275 |
| --- | --- |
| Applicant | Tokuyama Dental |
| Device Name | OMNICHROMA |
| Regulation Number | 21 CFR 872.3690 |
| Product Code | EBF |
| Device Class | II |
# 4. Device Description
DIAFIL Bulk FLOW is a composite dental resin for aesthetic restoration corresponding to Type 1, Class 2 and Group 1 of ISO4049 and is used in direct restoration of cavity by being polymerized in oral cavity.
| No. | Model Name | Composition |
| --- | --- | --- |
| 1 | DIAFIL Bulk FLOW Economic Package | 2g syringe x 5ea, Disposable Tip 18G x 25ea |
| 2 | DIAFIL Bulk FLOW Refill Package | 2g syringe x 1ea, Disposable Tip 18G x 5ea |
| 3 | DIAFIL Bulk FLOW 0.5g | 0.5g syringe x 1ea, Disposable Tip 18G x 1ea |
# 5. Indications for Use
- Base under Class I, II direct restorations
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DiaDent Group International
Product Name: DIAFIL Bulk FLOW
- Liner under direct restorative materials
- Repair of composite/ceramic veneers
- Restorations of small posterior cavities
- Undercut block-out
- Pit & Fissure sealant
# 6. Technological Characteristics
The subject device, DIAFIL Bulk FLOW has similar characteristics to the primary predicate device, OMNICHROMA.
[Comparison table]
| | Subject Device | Predicate Device | Discuss |
| --- | --- | --- | --- |
| 510(k) Number | - | K173275 | - |
| Product Code | EBF | EBF | Equivalent |
| Device Class | II | II | Equivalent |
| Manufacturer | DiaDent Group International | Tokuyama Dental Corporation | - |
| Device Name | DIAFIL Bulk FLOW | OMNICHROMA | - |
| Indications for Use | - Base under Class I, II direct restorations - Liner under direct restorative materials - Repair of composite/ceramic veneers - Restorations of small posterior cavities - Undercut block-out - Pit & Fissure sealant | - Direct anterior and posterior restorations - Direct bonded composite veneer - Diastema closure - Repair of porcelain/composite | * See the below table. |
| Raw Materials | - Bisphenol A poxymethacrylate /triethyleneglycol dimethacrylate - Triethyleneglycol dimethacrylate - Diurthane dimethacrylate - Long-chain Urethane dimethacrylate - Ethoxylated Bisphenol A dimethacrylate - Barium glass - Fumed silica - (+/-)-Camphorquinone - Ethyl 4-dimethylaminobenzoate - 2-Hydroxy-4-n-octoxybenzophenone - 2,6-di-tert-butyl-p-cresol | - 1, 6-bis(methacryl-ethyloxy carbonylamino)trimethylhexane(UDMA) - Triethylene glycol dimethacrylate(TEGDMA) | * See the below table. |
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DiaDent Group International
Product Name: DIAFIL Bulk FLOW
| | - 4-Methoxyphenol - Iron oxide red - Titanium dioxide | | |
| --- | --- | --- | --- |
| Principle of operation | The product is classified as a Type 1, Class 2, Group 1 material according to ISO 4049. It is a light-curing, aesthetic restorative composite resin intended for both anterior and posterior applications. The material consists of a paste containing unpolymerized dimethacrylate monomers, inorganic fillers, and a photoinitiator system. It is used for restorations requiring aesthetics due to dental caries or structural damage. After placement of the uncured material into the cavity, it is polymerized using a dental visible light-curing unit, resulting in a hardened and durable restoration. | Tooth shade resin material that is cured by photo polymerization. (Lightcure) | Equivalent |
| Performance Standard Conformance | Conformed ISO 4049 | Conformed ISO 4049 | Equivalent |
| Physical and Mechanical properties | - Water sorption - Solubility - Depth of Cure - Flexural strength - Colour - Colour stability - Radiopacity - Sensitivity to ambient light | - Sensitivity to ambient light - Depth of cure - Flexural strength - Water sorption - Solubility - Color stability - Radio-opacity | 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
- Indications for Use
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DiaDent Group International
Product Name: DIAFIL Bulk FLOW
| Subject Device | Predicate Device | Discussion |
| --- | --- | --- |
| - Base under Class I, II direct restorations - Liner under direct restorative materials - Repair of composite/ceramic veneers - Restorations of small posterior cavities - Undercut block-out - Pit & Fissure sealant | - Direct anterior and posterior restorations - Direct bonded composite veneer - Diastema closure - Repair of porcelain/composite | The indications of the subject device is similar to the indications of the predicate device, and it does not contain new indications. |
- Raw materials
| Subject Device | Predicate Device | Discussion |
| --- | --- | --- |
| - Bisphenol A epoxymethacrylate /triethyleneglycol dimethacrylate - Triethylene glycol dimethacrylate - Diurthane dimethacrylate - Urethane dimethacrylate - Ethoxylated Bisphenol A dimethacrylate - Barium glass - Fumed silica - (+/-)-Camphorquinone - Ethyl 4-dimethylaminobenzoate - 2-Hydroxy-4-n-octoxybenzophenone - 2,6-di-tert-butyl-p-cresol - 4-Methoxyphenol - Iron oxide red - Titanium dioxide | - 1, 6-bis(methacryl-ethyloxy carbonylamino)trimethylhexane (UDMA) - Triethylene glycol dimethacrylate(TEGDMA) | Triethylene glycol dimethacrylate, is contained in both subject device and predicate device. Through the biocompatibility test results, the difference does not raise any issue of safety and effectiveness. |
# 7. Non-Clinical Performance Data
The performance and biological tests were conducted on the subject device; DIAFIL Bulk FLOW 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 10993-10:2021, 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 10993-17:2023, Biological evaluation of medical devices—Part 17: Toxicological risk assessment of medical device constituents
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DiaDent Group International
Product Name: DIAFIL Bulk FLOW
ISO 10993-18:2020/Amd 1:2022, Biological evaluation of medical devices — Part 18: Chemical characterization of medical device materials within a risk management process—Amendment 1: Determination of the uncertainty factor
ISO 10993-23:2021, Biological evaluation of medical devices—Part 23: Tests for irritation
The test results corresponded to 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.
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