(266 days)
The Bluemoon is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials that are photopolymerized in the 385~515nm waveband of visible light.
The Bluemoon Dental Curing Light is an instrument for photopolymerizing dental materials and starting agents by irradiating them with visible light between 385-515nm wavelength. It offers four modes (HYPER, TURBO, LOW, and SOFT START) depending on the output intensity and irradiation time.
The FDA 510(k) clearance letter for the Bluemoon Dental Curing Light provides information on several aspects of device testing, but it does not detail acceptance criteria for all performance metrics, nor does it present the study in a format that directly addresses the specific questions about AI/human-in-the-loop and ground truth establishment for AI models. This device is a dental curing light, a hardware device, not an AI/ML software. Therefore, the concepts of "AI assistance," "human readers," "test set," "training set," "ground truth" as typically defined for AI/ML performance studies are not directly applicable here.
However, I can extract and interpret the provided information to answer the relevant questions as best as possible for a hardware medical device.
1. A table of acceptance criteria and the reported device performance
The document lists "Performance Data" which includes various properties and their corresponding values. These values can be interpreted as the acceptance criteria for those specific properties, and the implicit reported performance is that the device meets these criteria, as stated in the conclusion.
| Acceptance Criterion (Property) | Acceptance Value | Reported Device Performance |
|---|---|---|
| Irradiation time | SOFT START: 10 ± 1sLOW: 10 ± 1sTURBO: 5 ± 1sHYPER: 3 ± 1s | "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bluemoon met the established specifications necessary for consistent performance according to its intended use." (Implicitly, the device met these times.) |
| Peak wavelength | Check that the wavelength maxima occur within 5% of 400 nm and 455 nm respectively.1) Purple: 400nm ± 5%2) Blue: 455nm ± 5% | "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bluemoon met the established specifications necessary for consistent performance according to its intended use." (Implicitly, the device met these wavelength specifications.) |
| Polymerization strength measurement | ≥ 80 MPa | "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bluemoon met the established specifications necessary for consistent performance according to its intended use." (Implicitly, the device achieved ≥ 80 MPa.) |
| Depth of cure | ≥ 2.0 mm | "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bluemoon met the established specifications necessary for consistent performance according to its intended use." (Implicitly, the device achieved ≥ 2.0 mm.) |
| Light Probe temperature | ≤ 41 ℃ | "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bluemoon met the established specifications necessary for consistent performance according to its intended use." (Implicitly, the device maintained ≤ 41 ℃.) |
| Energy-saving mode | 60 ± 2s | "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bluemoon met the established specifications necessary for consistent performance according to its intended use." (Implicitly, the device functioned within 60 ± 2s for energy-saving mode.) |
| Turn off energy-saving mode | 1) Buzzer sounds once,2) LCD on | "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bluemoon met the established specifications necessary for consistent performance according to its intended use." (Implicitly, the device demonstrated these behaviors.) |
| Auto power off | 10 minutes ± 2 seconds | "All test results demonstrate that the materials chosen, the manufacturing process, and the design utilized for the Bluemoon met the established specifications necessary for consistent performance according to its intended use." (Implicitly, the device auto-powered off correctly.) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document describes "performance bench testing" but does not explicitly state the sample size (e.g., number of devices tested, number of dental material samples cured) for each test. Given it's a hardware device, the "test set" would refer to the units of the device and the materials it acts upon, rather than a dataset of clinical cases. The provenance of the data is not specified; however, the company is based in the Republic of Korea. The testing would be prospective (i.e., new tests conducted on the manufactured device) rather than retrospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable to a hardware dental curing light. "Ground truth" for this device is established by objective physical measurements (e.g., wavelength, power output, temperature, polymerization depth and strength measured by calibrated instruments) rather than expert interpretation of images or clinical findings. Therefore, no experts in the sense of trained clinicians interpreting data were used for establishing ground truth for the performance tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable to a hardware dental curing light. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in clinical or image-based studies where expert consensus is required for ambiguous cases. The performance tests for this device involve objective measurements.
5. 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
This question is not applicable. The Bluemoon is a dental curing light, not an AI-powered diagnostic or assistive tool. It does not involve "human readers" or "AI assistance."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The Bluemoon is a hardware device; there is no standalone algorithm to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance data listed (Irradiation time, Peak wavelength, Polymerization strength, Depth of cure, Light Probe temperature, Energy-saving mode, Auto power off), the "ground truth" is established through objective physical measurements using calibrated instruments and standardized test methods. For biocompatibility, the ground truth is established by the results of specific biocompatibility tests (Cytotoxicity, Skin Sensitization, Intracutaneous reactivity) conducted according to ISO 10993 standards.
8. The sample size for the training set
This question is not applicable. The Bluemoon is a hardware device and does not involve a "training set" in the context of machine learning or AI models. Its design and manufacturing process are validated through engineering principles and bench testing.
9. How the ground truth for the training set was established
This question is not applicable as there is no training set for this hardware device.
FDA 510(k) Clearance Letter - Bluemoon Dental Curing Light
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 5, 2025
GENOSS Co., Ltd.
Jiyeon Lee
Regulatory affair
12F, 76, Changnyong-daero 256beon-gil, Yeongtong-gu
Manufacturing site: 3F, 4F, 5F, D-factory, 56, Changnyong-da
Suwon-si, Gyeonggi-do
China
Re: K242386
Trade/Device Name: Bluemoon
Regulation Number: 21 CFR 872.6070
Regulation Name: Ultraviolet Activator For Polymerization
Regulatory Class: Class II
Product Code: EBZ
Dated: September 8, 2024
Received: April 29, 2025
Dear Jiyeon 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.
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K242386 - Jiyeon Lee 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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K242386 - Jiyeon Lee 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,
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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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
510(k) Number (if known)
K242386
Device Name
Bluemoon
Indications for Use (Describe)
The Bluemoon is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials that are photopolymerized in the 385~515nm waveband of visible light.
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)
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FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
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510(k) Summary
K242386
04/28/2025
1. Company
| Submitter | GENOSS Co., Ltd. |
|---|---|
| Name | GENOSS Co., Ltd. |
| Address | Head Office: 12F, 76, Changnyong-daero 256beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, Republic of KoreaManufacturing site: D-Factory, 56, Changnyong-daero 256beon-gil, Yeongtong-gu, Suwon-si, Gyeonggi-do, Korea |
| Phone/Fax | +82-70-7098-6923/ +82-31-888-5595 |
| Contact person | Jiyeon Leejylee3@genoss.com |
| Summary Date | 04/28/2025 |
2. Device Name
- Trade name: Bluemoon
- Common name: Dental Curing Light Device
- Classification name: Ultraviolet activator for polymerization, 21 CFR 872.6070, product code EBZ, Device Class II
3. Predicate Device
K200809 D-Lux+ (Primary predicate)
4. Description
The Bluemoon Dental Curing Light is an instrument for photopolymerizing dental materials and starting agents by irradiating them with visible light between 385-515nm wavelength. It offers four modes (HYPER, TURBO, LOW, and SOFT START) depending on the output intensity and irradiation time.
5. Indication for use
The Bluemoon is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials that are photopolymerized in the 385~515nm wavelength of visible light.
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6. Comparison Technological Characteristics with the Predicate Devices
Bluemoon was compared with the predicate device 'D-Lux+'. The characteristics that differed from the predicate device were performed by gap analysis, which confirmed equivalence with the predicate device. Technological characteristics of Bluemoon and D-Lux+ are as following;
| Item | Proposed Device | Predicate Device K200809 | Remark |
|---|---|---|---|
| Device name | Bluemoon | D-Lux+ | - |
| Classification | |||
| Regulation | 21 CFR 872.6070 | 21 CRF 872.6070 | Same |
| Classification | II | II | Same |
| Product Code | EBZ | EBZ | Same |
| Common Name | Activator, ultraviolet for polymerization | Activator, ultraviolet for polymerization | Same |
| Indications for use | The Bluemoon is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials that are photopolymerized in the 385~515nm wavelength of visible light. | The D-Lux+ is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials that are photo-polymerized in the 385~515nm waveband of visible light | Same |
| Use | Prescription / Hospital | Prescription / Hospital | Same |
| Delivery form content | - Light probe- Main body- Battery pack- Charger- Anti-glare shield- USB C to C cable- Disposable vinyl cover- User Manual | -D-Lux+ Handpiece-C-Battery-D-Lux+ Charger-Adapter-Power Cord-Disposable sheath-Light Probe-Light Protector-Instruction Manual | Gap (1) |
| Wavelength range | 385nm - 515nm | 385nm - 515nm | Same |
| Peak wavelength | Dual peak: 410nm, 460nm | Dual peak: 405nm, 460nm | Gap (2) |
| Operational modes | 4 programs:-Hyper: 3s(3000mW/cm²)-Turbo: 5s(2500mW/cm²)-Low: 10s(1200mW/cm²)-Soft Start: 10s(0~2000mW/cm²) | 5 modes-STD (Standard) mode: 900mW/cm²5, 10, 15 and 20 seconds-SFT (Soft Start) mode: 1300mW/cm²10, 15 seconds-HIG (High Power) mode:1300mW/cm²5, 10 and 15 seconds-ORT (Orthodontic) mode:1800mW/cm²3, 4, 5 seconds-MAX (Max Power) mode:2400mW/cm²1, 2, 3 seconds | Gap (3) |
| Power Source | 3.7V DC with Lithium ion battery5V DC with charger power | 3.6V DC with Lithium ion battery6V DC with charger power | Gap (4) |
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| Light source | LED light | LED light | Same |
|---|---|---|---|
| Electrical | IEC 60601-1 | IEC 60601-1 | Same |
| Safety | IEC 60601-1- 2 | IEC 60601-1-2 | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Biocompatibility | ISO 10993-1ISO 10993-5ISO 10993-10ISO 10993-23 | Direct contact with issue in not intended. Therefore ISO 10993-1 is not applicable. | Gap (5) |
6.1 Gap Analysis
Gap (1): The Main body (has a built-in battery), charger, Light probe, Anti-glare shield, adapter, Disposal vinyl cover of proposed device have the same functions with the D-Lux+ Handpiece, D-Lux+ Charger, Light Probe, Light Protector, C-Battery (Included in the handpiece), Adapter, Power Cord and Disposable Sheaths of the D-Lux+. Both devices adopt the cordless pen-style.
Gap (2): The peak wavelength values of the predecessor and application devices are very similar. The predicate device is 405, 460 nm and the proposed device is 410, 460 nm. Because the dual peak wavelengths of the two devices are so similar, they do not affect the safety or efficacy of the product.
Gap (3): The proposed device has several modes corresponding to the light output intensity and the available time. The light output safety and performance tests were performed according to IEC 60601-1, IEC 60601-1-2 and FDA guidance performance test requirements. The test results show that these differences do not affect safety and effectiveness. Therefore, it is determined that these mode differences do not cause substantial equivalence issues.
Gap (4): Both devices use the internal rechargeable lithium ion battery. Though the battery technical specification of proposed device is a bit different from that of the predicate device, the battery of proposed device meets the IEC 62133-2 standard. This difference does not affect safety and effectiveness.
Gap (5): Biocompatibility testing of the subject device was conducted because although the device does not come in contact with oral tissue on the chance that contact does occur. However, the predicate device is not evaluated. The testing results show that these differences do not affect safety and effectiveness.
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7. Biocompatibility Data
Biocompatibility testing was conducted because although the device does not come in contact with oral tissue on the chance that contact does occur. The biocompatibility evaluation for the Bluemoon was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:
- Cytotoxicity
- Skin Sensitization
- Intracutaneous reactivity test report
8. Performance Data
Bluemoon was evaluated using the following performance bench testing to confirm the performance characteristics:
| No. | Title | Properties |
|---|---|---|
| 1 | Irradiation time | 1) SOFT START: 10±1s2) LOW: 10±1s3) TURBO: 5±1s4) HYPER: 3±1s |
| 2 | Peak wavelength | Check that the wavelength maxima occur within 5% of 400 nm and 455 nm respectively.1) Purple: 400nm±5%2) Blue: 455nm±5% |
| 3 | Polymerization strength measurement | ≥ 80MPa |
| 4 | Depth of cure | ≥ 2.0mm |
| 5 | Light Probe temperature | ≤ 41℃ |
| 6 | Energy-saving mode | 60±2s |
| 7 | Turn off energy-saving mode | 1) Buzzer sounds once,2) LCD on |
| 8 | Auto power off | 10 minutes ± 2 seconds |
All test results demonstrate that the materials chosen, the manufacturing process, and the design
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utilized for the Bluemoon met the established specifications necessary for consistent performance according to its intended use.
9. Conclusion
Performance testing and compliance with voluntary standards demonstrate that the proposed subject device is substantially equivalent to the predicate device.
§ 872.6070 Ultraviolet activator for polymerization.
(a)
Identification. An ultraviolet activator for polymerization is a device that produces ultraviolet radiation intended to polymerize (set) resinous dental pit and fissure sealants or restorative materials by transmission of light through a rod.(b)
Classification. Class II.