(115 days)
Not Found
No
The device description and specifications provided do not mention any AI, DNN, or ML components or functionalities. The device is a dental composite resin.
No.
The device is a restorative material for direct restorations, core build-up, and repair of aesthetic restorations, not a therapeutic device designed to treat or cure a disease or medical condition.
No
Explanation: The device is a dental restorative material (composite resin) used for direct restorations, core build-up, and repair. It is designed to treat or restore, not to diagnose conditions.
No
The device is a light-cured radiopaque flowable composite resin, which is a physical material used for dental restorations. The summary discusses its physical properties, such as viscosity, particle size, and mechanical strength, and includes performance studies on depth of cure, flexural strength, and compressive strength. There is no mention of software components, algorithms, AI, or data processing.
No.
This device is a dental restorative material, not a diagnostic tool used to examine specimens derived from the human body.
N/A
Intended Use / Indications for Use
- Direct restorations
- Base and Liner
- Block out undercut
- Repair of (in)direct aesthetic restorations
- Core build-up
Product codes
EBF
Device Description
EsFlow PLUS is a light-cured radiopaque flowable composite resin used for direct restoration. It has a smooth surface, so it is applied smoothly to the teeth, and has good gloss and aesthetics. In addition, it has high mechanical strength, so it can sufficiently withstand the occlusal force. EsFlow PLUS has two types of viscosities, so it can be applied to various clinical cases. The inorganic filler of EsFlow PLUS has a particle size range of 0.01 to 0.5 microm, and a volume ratio of about 42 to 47% depending on the model.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Depth of cure, flexural strength, and compressive strength test of the subject device (EsFlow PLUS) and the predicate device (G-ænial Universal Injectable) were performed in accordance with ISO 4049 and part of ISO 9917-1 (Compressive strength).
The depth of cure and flexural strength test results of the subject device and predicate device meet the ISO 4049 requirements, and the values of those performances were as good as those of predicate device. Also, the compressive strength value of the subject device was higher than that of predicate device. Therefore, It can be considered that our subject device is as safe, effective and performs as well as or better than the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3690 Tooth shade resin material.
(a)
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.(b)
Classification. Class II.
FDA 510(k) Clearance Letter - EsFlow PLUS
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 30, 2025
Spident CO. LTD
Hyemin Kwon
RA Staff
203 & 312, Korea Industrial Complex, 722, Gojan-Dong
Namdong-Gu
Incheon, 405-821
SOUTH KOREA
Re: K250317
Trade/Device Name: EsFlow PLUS
Regulation Number: 21 CFR 872.3690
Regulation Name: Tooth Shade Resin Material
Regulatory Class: Class II
Product Code: EBF
Dated: April 30, 2025
Received: April 30, 2025
Dear Hyemin Kwon:
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.
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K250317 - Hyemin Kwon
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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (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 systems (QS) regulation (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-
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K250317 - Hyemin Kwon
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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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
Submission Number (if known)
K250317
Device Name
EsFlow PLUS
Indications for Use (Describe)
- Direct restorations
- Base and Liner
- Block out undercut
- Repair of (in)direct aesthetic restorations
- Core build-up
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Page 5
510(k) Summary
510(k) #: K250317
Prepared on: 2025-02-13
Contact Details
21 CFR 807.92(a)(1)
| Field | Information |
|---|---|
| Applicant Name | SPIDENT CO., LTD. |
| Applicant Address | 203 & 312, Korea Industrial Complex, 722, Gojan-Dong, Namdong-Gu, Incheon, Korea, 405-821 Incheon Incheon 405-821 Korea, South |
| Applicant Contact Telephone | +82-32-821-0072 |
| Applicant Contact | Ms. Hyemin Kwon |
| Applicant Contact Email | hyemin729@spident.co.kr |
Device Name
21 CFR 807.92(a)(2)
| Field | Information |
|---|---|
| Device Trade Name | EsFlow PLUS |
| Common Name | Tooth shade resin material |
| Classification Name | Material, Tooth Shade, Resin |
| Regulation Number | 872.3690 |
| Product Code(s) | EBF |
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K173500 | Nmf004a (G-ænial Universal Injectable) | EBF |
Device Description Summary
21 CFR 807.92(a)(4)
EsFlow PLUS is a light-cured radiopaque flowable composite resin used for direct restoration. It has a smooth surface, so it is applied smoothly to the teeth, and has good gloss and aesthetics. In addition, it has high mechanical strength, so it can sufficiently withstand the occlusal force. EsFlow PLUS has two types of viscosities, so it can be applied to various clinical cases. The inorganic filler of EsFlow PLUS has a particle size range of 0.01 to 0.5 μm, and a volume ratio of about 42 to 47% depending on the model.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
- Direct restorations
- Base and Liner
- Block out undercut
- Repair of (in)direct aesthetic restorations
- Core build-up
Indications for Use Comparison
21 CFR 807.92(a)(5)
The indication for use of the subject device are all included in the indication for use of the predicate device. There are some differences in expression, but they both can be used in direct restorations, base and liner, block out undercut, repair of (in)direct aesthetic restorations, and core build-up. Therefore, this would not raise any new questions of safety and effectiveness.
Technological Comparison
21 CFR 807.92(a)(6)
Page 6
Principle Operation, Biocompatibility, Application Area, Target Population of subject device and predicate device are the same. The performance results of the subject device and predicate device is not the same, but all products meet the requirements of ISO 4049. Light curing time between the subject device and predicate device is different, but the light curing time of the subject device is longer than that of the predicate device. Therefore, This would not raise any new questions of safety and effectiveness. Also, both subject device and predicate device have the similar intended operator.
In case of storage condition, both products have similar limit of temperature.
Therefore, EsFlow PLUS is substantially equivalent with predicate device, G-ænial Universal Injectable, and at least as safe and effective as the predicate device.
Non-Clinical and/or Clinical Tests Summary & Conclusions
21 CFR 807.92(b)
Depth of cure, flexural strength, and compressive strength test of the subject device (EsFlow PLUS) and the predicate device (G-ænial Universal Injectable) were performed in accordance with ISO 4049 and part of ISO 9917-1 (Compressive strength).
Not Applicable
The depth of cure and flexural strength test results of the subject device and predicate device meet the ISO 4049 requirements, and the values of those performances were as good as those of predicate device. Also, the compressive strength value of the subject device was higher than that of predicate device. Therefore, It can be considered that our subject device is as safe, effective and performs as well as or better than the predicate device.