(79 days)
Crown, Bridges, Veneer, Onlay & Inlay, Denture, partial denture, Orthodontic appliance, Splints.
- Characterization of direct & indirect composite restorations, acrylic denture base and artificial acrylic teeth.
- For obtaining surface smoothness and wear resistance of restorations made of composite resin, acrylic denture base and artificial acrylic teeth.
ID LIGHT CURE SYSTEM is a light-curing resin-based coating material for dental use. It is designed to form a film on the resin surface of dental restorations and prosthetic appliances to enhance smoothness and wear resistance. The material is available in 51 shades.
This document is a 510(k) clearance letter for a dental device, the "ID LIGHT CURE SYSTEM." It's important to note that a 510(k) submission primarily demonstrates substantial equivalence to a previously cleared device, rather than proving a new device's absolute safety and effectiveness through extensive clinical trials as might be required for a PMA (Pre-Market Approval).
Therefore, the "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical and biological safety tests performed to demonstrate that the new device performs similarly to the predicate device and does not pose new safety concerns. There is no information in this document about acceptance criteria and performance data for an AI-based or software-driven diagnostic or prognostic device. The product is a physical dental material, a "light-curing resin-based coating material."
Given the nature of the device (a coating material for resin fillings), concepts like "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone AI performance," "number of experts for ground truth," or "effect size of human readers with AI assistance" are not applicable. This device is a material, not an AI or imaging diagnostic tool.
However, I will extract the information that is available and clarify what is not applicable based on the provided text for a physical dental material.
Acceptance Criteria and Device Performance (Based on provided 510(k) Summary)
Since this is a physical dental material and not an AI/software device, the "acceptance criteria" are related to its physical and biological properties. The document states that the device "successfully passed all evaluations, demonstrating acceptable physical characteristics and confirming that the product meets its intended technical and performance specifications." This implicitly means the product met its internal acceptance criteria.
Table of Acceptance Criteria and Reported Device Performance
| Category | Specific Criteria (Implicitly Met) | Reported Device Performance |
|---|---|---|
| Biological Safety | No added substances specifically inducing toxicity compared to the predicate. No significantly different elements or mixing ratios compared to the predicate. Absence of cytotoxic reactions. Absence of oral mucosal irritation or skin sensitization reactions. Absence of systemic toxic reactions. | "no observed cytotoxic reactions, no oral mucosal irritation or skin sensitization reactions, and no systemic toxic reactions." "sufficient data on toxicity and benefits can be observed through the review of literature with long-term use experience" (for some models). Considered to not contain added substances specifically inducing toxicity or significantly different elements/mixing ratios compared to predicate. |
| Physical Properties | Acceptable appearance. Acceptable weight. Packaging integrity. Color stability. Sensitivity to ambient light within acceptable limits. Adequate depth of cure. | "All tests were performed in accordance with internal protocols and relevant standards. The device successfully passed all evaluations, demonstrating acceptable physical characteristics and confirming that the product meets its intended technical and performance specifications." |
| Substantial Equivalence | Demonstrated substantial equivalence to the predicate device (OPTIGLAZE COLOR, K133836) in terms of: - Indications for Use - Design - Material and chemical composition - Principle of Operation - Energy source | Indications for Use are stated to be the "same." Technical characteristics (Design, Material, Principle of Operation, Energy source) are stated to be the "same." Device is "substantially equivalent to the predicate device." |
Study Details (Applicable points only, based on provided text)
-
Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a number of "samples" in a clinical trial sense. For biological safety, tests were performed according to ISO 10993-1:2018 and ISO 7405:2018, which dictate sample sizes for specific in-vitro and in-vivo tests but these are not enumerated here. For physical properties, "a series of performance tests were conducted," but a specific sample size for each test is not provided.
- Data Provenance: Not specified. Standardized biological safety tests (ISO standards) are generally conducted in a controlled lab environment. Physical property tests are conducted internally. It is not specified if any data was retrospective or prospective.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a physical dental material; "ground truth" and "expert adudication" as typically understood for AI diagnostic devices (e.g., radiologists interpreting images) do not apply. Biological safety and physical property tests have objective measurements and pass/fail criteria based on standards.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. See point 2.
-
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is a physical dental material, not an AI or imaging diagnostic device.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This refers to AI algorithm performance.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For Biological Safety: Ground truth is established by adherence to international standards (ISO 10993-1:2018 and ISO 7405:2018) and objective biological endpoints (cytotoxicity, irritation, systemic toxicity).
- For Physical Properties: Ground truth is established by "internal protocols and relevant standards" with objective measurements (appearance, weight, packaging, color stability, sensitivity, depth of cure).
- No expert consensus, pathology, or outcomes data in the sense of clinical decision-making is relevant here.
-
The sample size for the training set:
- Not Applicable. This is a physical dental material, "training set" refers to machine learning.
-
How the ground truth for the training set was established:
- Not Applicable. See point 7.
FDA 510(k) Clearance Letter - ID Light Cure System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 4, 2025
Id Korea Co., Ltd.
Eunhui Lim
Official Correspondent
405, 150, Donggyecheon-ro
Dong-gu, Gwangju 61436
SOUTH KOREA
Re: K250804
Trade/Device Name: ID Light Cure System
Regulation Number: 21 CFR 872.3310
Regulation Name: Coating Material For Resin Fillings
Regulatory Class: Class II
Product Code: EBD, EBI, EBF, MQC, KMY
Dated: March 17, 2025
Received: March 17, 2025
Dear Eunhui Lim:
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.
Page 2
K250804 - Eunhui Lim
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-
Page 3
K250804 - Eunhui Lim
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
Page 4
FORM FDA 3881 (8/23)
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: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K250804
Device Name: ID LIGHT CURE SYSTEM
Indications for Use (Describe):
Crown, Bridges, Veneer, Onlay & Inlay, Denture, partial denture, Orthodontic appliance, Splints.
- Characterization of direct & indirect composite restorations, acrylic denture base and artificial acrylic teeth.
- For obtaining surface smoothness and wear resistance of restorations made of composite resin, acrylic denture base and artificial acrylic teeth.
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."
Page 5
510(k) Summary
Prepared on: 2025-03-17
Contact Details
21 CFR 807.92(a)(1)
| Field | Value |
|---|---|
| Applicant Name | ID KOREA CO., LTD. |
| Applicant Address | 405, 150, Donggyecheon-ro Dong-gu Gwangju 61436 Korea, South |
| Applicant Contact Telephone | 01056887291 |
| Applicant Contact | Mrs. EUNHUI LIM |
| Applicant Contact Email | cns@cnsbest.co.kr |
Device Name
21 CFR 807.92(a)(2)
| Field | Value |
|---|---|
| Device Trade Name | ID LIGHT CURE SYSTEM |
| Common Name | Coating material for resin fillings |
| Classification Name | Coating, Filling Material, Resin |
| Regulation Number | 872.3310 |
| Product Code(s) | EBD, EBI, EBF, MQC, KMY |
Legally Marketed Predicate Devices
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K133836 | OPTIGLAZE COLOR | EBD |
Device Description Summary
21 CFR 807.92(a)(4)
ID LIGHT CURE SYSTEM is a light-curing resin-based coating material for dental use. It is designed to form a film on the resin surface of dental restorations and prosthetic appliances to enhance smoothness and wear resistance. The material is available in 51 shades.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
Crown, Bridges, Veneer, Onlay & Inlay, Denture, partial denture, Orthodontic appliance, Splints.
- Characterization of direct and indirect composite restorations, acrylic denture base and artificial acrylic teeth.
- For obtaining surface smoothness and wear resistance of restorations made of composite resin, acrylic denture base and artificial acrylic teeth.
Indications for Use Comparison
21 CFR 807.92(a)(5)
The indications for use are the same between the subject and predicate device.
Technological Comparison
21 CFR 807.92(a)(6)
It has the same technical characteristics as a predicate device.
- Design: Materials are applied to restoration surfaces.
- Material and chemical composition: resin-based compositions cured by photopolymerization.
- Principle of Operation: After application, use photopolymer to irradiate light to cure the coating layer.
- Energy source: Hardens coating agents using photopolymers that emit light of a specific wavelength.
Page 6
Non-Clinical and/or Clinical Tests Summary & Conclusions
21 CFR 807.92(b)
Upon evaluating the biological safety of the "ID LIGHT CURE SYSTEM (Model Name: CROWN FLOW A1 and 50 others)" it is considered that this product does not contain any added substances that specifically induce toxicity or have significantly different elements or mixing ratios compared to the predicate named "OPTIGLAZE COLOR" on the market. Furthermore, no significant differences in intended use or mechanism of action were found when compared to the predicate device. Cytotoxicity, skin sensitization, oral mucosa irritation, and acute systemic toxicity endpoint testing were performed for the subject device in accordance with ISO 10993-1:2018 and ISO 7405:2018.
Evaluation of the biological safety test reports for the "ID LIGHT CURE SYSTEM (Model: GUM FLOW BLACK)" showed no observed cytotoxic reactions, no oral mucosal irritation or skin sensitization reactions, and no systemic toxic reactions. Regarding additional biological safety tests for the "ID LIGHT CURE SYSTEM (Model Name: CROWN FLOW A1 and 50 others)," sufficient data on toxicity and benefits can be observed through the review of literature with long-term use experience.
A series of performance tests were conducted to evaluate the physical properties of the device, including appearance, weight, packaging integrity, color stability, sensitivity to ambient light, and depth of cure. All tests were performed in accordance with internal protocols and relevant standards. The device successfully passed all evaluations, demonstrating acceptable physical characteristics and confirming that the product meets its intended technical and performance specifications.
In conclusion, when the "ID LIGHT CURE SYSTEM (Model Name: CROWN FLOW A1 and 50 others)" is used according to the intended purpose and method of use provided by the manufacturer, the device is substantially equivalent to the predicate device.
§ 872.3310 Coating material for resin fillings.
(a)
Identification. A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.(b)
Classification. Class II.