(266 days)
Not Found
No
The provided text describes a dental curing light that polymerizes resinous materials using visible light. It mentions various operational modes, wavelengths, and performance metrics but does not include any terms related to AI, machine learning, or deep learning, nor does it describe any functionality that would require an AI model.
Yes
The device is used to polymerize dental materials, which is a therapeutic process to restore or bond dental structures.
No
The device is a dental curing light, which polymerizes resinous dental materials using visible light. Its purpose is therapeutic/procedural (curing materials), not diagnostic.
No
The device description, intended use, and performance studies clearly indicate that the "Bluemoon Dental Curing Light" is a physical instrument that emits visible light to polymerize dental materials. It has measurable physical properties like wavelength, intensity, temperature, and performs a physical action, making it a hardware device, not a software-only medical device.
No
The device is a dental curing light, used for photopolymerizing dental materials, not for in vitro examination of specimens derived from the human body.
N/A
Intended Use / 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 waveband of visible light.
Product codes (comma separated list FDA assigned to the subject device)
EBZ
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription / Hospital
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)
Bluemoon was evaluated using the following performance bench testing to confirm the performance characteristics:
- Irradiation time:
- SOFT START: 10±1s
- LOW: 10±1s
- TURBO: 5±1s
- HYPER: 3±1s
- Peak wavelength: Check that the wavelength maxima occur within 5% of 400 nm and 455 nm respectively.
- Purple: 400nm±5%
- Blue: 455nm±5%
- Polymerization strength measurement: ≥ 80MPa
- Depth of cure: ≥ 2.0mm
- Light Probe temperature: ≤ 41℃
- Energy-saving mode: 60±2s
- Turn off energy-saving mode:
- Buzzer sounds once,
- LCD on
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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
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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
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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,
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
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
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)
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
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"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."
FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
Page 5
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 Korea |
| Manufacturing 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 Lee |
| jylee3@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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510(k) Summary
Page 2 of 5
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/cm²
5, 10, 15 and 20 seconds
-SFT (Soft Start) mode: 1300mW/cm²
10, 15 seconds
-HIG (High Power) mode:
1300mW/cm²
5, 10 and 15 seconds
-ORT (Orthodontic) mode:
1800mW/cm²
3, 4, 5 seconds
-MAX (Max Power) mode:
2400mW/cm²
1, 2, 3 seconds | Gap (3) |
| Power Source | 3.7V DC with Lithium ion battery
5V DC with charger power | 3.6V DC with Lithium ion battery
6V DC with charger power | Gap (4) |
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510(k) Summary
Page 3 of 5
| 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 10993-1 | ||
| ISO 10993-5 | |||
| ISO 10993-10 | |||
| ISO 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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510(k) Summary
Page 4 of 5
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±1s |
- LOW: 10±1s
- TURBO: 5±1s
- HYPER: 3±1s |
| 2 | Peak wavelength | Check that the wavelength maxima occur within 5% of 400 nm and 455 nm respectively. - Purple: 400nm±5%
- 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, - 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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510(k) Summary
Page 5 of 5
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.