Curing Light (M-Cure 6)
Device Facts
| Record ID | K253131 |
|---|---|
| Device Name | Curing Light (M-Cure 6) |
| Applicant | Guangzhou Rebornendo Medical Instrument Co., Ltd. |
| Product Code | EBZ · Dental |
| Decision Date | Jun 18, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.6070 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
The Curing Light (model: M-Cure 6) 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.
Device Story
Cordless, pen-style LED dental curing light; battery-operated; used by dental professionals in clinical settings. Device emits blue and violet light (385-515nm) to polymerize photo-activated dental materials. Features multiple operational modes (Standard, Fast, Soft, Pulse, Ortho, Caries checking) with varying light intensities. Includes main unit, light guide, light hood, bracket, and adapter. Disposable isolation sleeves prevent cross-contamination. Healthcare providers select mode and intensity based on clinical requirements; device output facilitates rapid curing of restorative materials and adhesives, improving procedural efficiency.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including irradiance, peak wavelength, depth of cure, electrical safety (ANSI AAMI ES60601-1), electromagnetic compatibility (IEC 60601-1-2), photobiological safety (IEC 62471), and biocompatibility (ISO 10993-5, -10, -23).
Technological Characteristics
Cordless LED polymerization activator; 385-515nm wavelength; dual peak (405nm, 460nm). Powered by 3.7V/2000mAh Li-ion battery. Materials include PE for disposable sleeves. Complies with ISO 10650:2018, IEC 60601-1, IEC 60601-1-2, IEC 80601-2-60, and IEC 62471. Software verified per IEC 62304.
Indications for Use
Indicated for polymerization of resinous dental materials, restorative composites, and orthodontic brackets, bonding, and sealing materials in the 385-515nm waveband. For use by qualified dental personnel in hospital, clinic, or dental office environments.
Regulatory Classification
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.
Predicate Devices
- CuringPen Dental Curing Light (K221152)
Reference Devices
Submission Summary (Full Text)
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**FDA** **U.S. FOOD & DRUG**
ADMINISTRATION
June 18, 2026
Guangzhou Rebornendo Medical Instrument Co., Ltd.
% Yijie You
General Manager
Qimmiq Medical Consulting Service Co., Ltd.
Rm.406, Bldg. C, Run Science Park
#18 Shenzhou Rd., Huangpu
Guangzhou, Guangdong 510663
China
Re: K253131
Trade/Device Name: Curing Light (M-Cure 6)
Regulation Number: 21 CFR 872.6070
Regulation Name: Ultraviolet Activator For Polymerization
Regulatory Class: Class II
Product Code: EBZ
Dated: June 15, 2026
Received: June 16, 2026
Dear Yijie You:
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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K253131 - Yijie You
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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 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-
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K253131 - Yijie You
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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,
**FDA** 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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# Indications for Use
Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions.
K253131
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Please provide the device trade name(s).
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Curing Light (M-Cure 6)
Please provide your Indications for Use below.
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The Curing Light (model: M-Cure 6) 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.
Please select the types of uses (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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K253131
# 510(K) Summary
## 1. 510(k) owner (Applicant)
| Establishment Registration number: | | / |
| --- | --- | --- |
| Name: | | Guangzhou RebornEndo Medical Instrument Co., Ltd. |
| Address: | | Room 309, Building No.5, No.2, Xingye Road, Nansha District, Guangzhou City, Guangdong Province, China. |
| Contact Person | Name: | Ye Cuimei |
| | Address: | No.1 Baisheng Road Development Zone, Danyang, Jiangsu 212300 CHINA |
| | TEL: | +86-15820261321 |
| | Email: | Sales4@rebornendo.com |
## 2. Contact Person (Authorized representative)
| Name: | You Yijie |
| --- | --- |
| Address: | RM.406, Building C, Run Science Park, No.18 Shenzhou Road, Huangpu, Guangzhou, Guangdong 510663 P.R. China |
| TEL: | (+86)020-82245821 |
| FAX: | (+86)020-82245821 |
| Email: | jet.you@qimmiq-med.com |
Date prepared: June 18, 2026
## 3. Device Information
Trade Name: Curing Light
Model: M-Cure 6
Classification name: Ultraviolet activator for polymerization
Review panel: Dental
Product code: EBZ
Regulation Class: II
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Regulation Number: 872.6070
## 4. Predicate Device and reference device Information
### *Primary predicate device:*
| 510(k) submitter/holder: | Changzhou Sifary Medical Technology Co., Ltd. |
| --- | --- |
| 510(K) Number: | K221152 |
| Trade Name: | CuringPen Dental Curing Light |
| Model: | CuringPen |
| Classification name: | Activator, ultraviolet, for polymerization |
| Review panel: | Dental |
| Product code: | EBZ |
| Regulation Class: | II |
| Regulation Number: | 872.6070 |
### *Reference device:*
| 510(k) submitter/holder: | DiaDent Group International |
| --- | --- |
| 510(K) Number: | K200809 |
| Trade Name: | D-Lux+ |
| Model: | D-Lux+ |
| Classification name: | Activator, ultraviolet, for polymerization |
| Review panel: | Dental |
| Product code: | EBZ |
| Regulation Class: | II |
| Regulation Number: | 872.6070 |
| 510(k) submitter/holder: | Garrison Dental Solutions, LLC |
| --- | --- |
| 510(K) Number: | K200775 |
| Trade Name: | LOOPTM LED Curing Light System |
| Model: | CLK01 |
| Classification name: | Activator, ultraviolet, for polymerization |
| Review panel: | Dental |
| Product code: | EBZ |
| Regulation Class: | II |
| Regulation Number: | 872.6070 |
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## 5. Device description
The Curing Light (model: M-Cure 6) is designed to polymerize all photo-activated dental materials in the wavelength range of 385-515 nm. It is a cordless pen-style, LED light polymerization device, and must only be used in hospital environments, clinics or dental offices by qualified dental personnel.
The Curing Light, model: M-Cure 6, consists of main unit, light guide, light hood, bracket, and adapter. The unit is battery operated and contains an internal battery pack with Li batteries.
## 6. Indications for Use
The Curing Light (model: M-Cure 6) 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.
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## 7. Comparison to predicate device
Comparison Analysis: The subject device is substantially equivalent to the predicate device, CuringPen Dental Curing Light, Model: CuringPen marketed by Changzhou Sifary Medical Technology Co., Ltd., the substantial equivalence chart is provided as follows:
| Comparisons | Subject device (Curing light, model: M-Cure 6) | Predicate Device (CuringPen Dental Curing Light) | Reference device (D-Lux+) | Reference device LOOP LED Curing Light System (Model: CLK01) | Discussion of difference |
| --- | --- | --- | --- | --- | --- |
| **510(k) Number** | K253131 | K221152 | K200809 | K200775 | / |
| **Classification** | 21 CFR 872.6070 | 21 CFR 872.6070 | 21 CFR 872.6070 | 21 CFR 872.6070 | / |
| **Product Code** | EBZ | EBZ | EBZ | EBZ | / |
| **FDA Class** | Class II | Class II | Class II | Class II | / |
| **Indication for use** | The Curing Light (model: M-Cure 6) 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. | The CuringPen Dental Curing Light is intended to polymerize resinous dental materials, restorative composite materials, and orthodontic brackets, bonding and sealing materials that are photo polymerized in the 380~515nm waveband of visible light. This device must | 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 | The LOOP is a source of illumination for curing photo-activated dental restorative materials and adhesives. | **Similar, See D1** |
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| Comparisons | | Subject device (Curing light, model: M-Cure 6) | Predicate Device (CuringPen Dental Curing Light) | Reference device (D-Lux+) | Reference device LOOP LED Curing Light System (Model: CLK01) | Discussion of difference |
| --- | --- | --- | --- | --- | --- | --- |
| | | | only be used in hospital environments, clinics or dental offices by qualified dental personnel and not used in oxygen rich environment. | waveband of visible light. | | |
| **Intended User** | | Dentist or dental professional | Dentist or dental professional | Dentist or dental professional | Dentist or dental professional | **Same** |
| **Device Design** | **Power source** | Lithium battery:3.7V/ 2000mAh | 3.7V DC with Lithium ion battery 5V DC with charger power | C-Battery | Litium Ion 18650 with a working voltage of 3.7 VDC | **Similar, See D2** |
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| Comparisons | | Subject device (Curing light, model: M-Cure 6) | Predicate Device (CuringPen Dental Curing Light) | Reference device (D-Lux+) | Reference device LOOP LED Curing Light System (Model: CLK01) | Discussion of difference |
| --- | --- | --- | --- | --- | --- | --- |
| | **Operational modes** | Standard mode (M1, M2, M3) Fast curing mode, Soft mode, Pulse mode, Ortho mode, Caries checking mode | Standard mode RAMP mode, PULSE mode, Detect mode, | STD (Standard) mode, SFT (Soft Start) mode, HIG (High Power) mode, ORT (Orthodontic) mode, MAX (Max Power) mode | Repeat Mode Direct Restorative Mode Turbo Mode | **Different, See D3** |
| | **Light source** | LED light, blue and violet Wavelengths(385nm ~ 515nm) | LED light | LED light blue and violet Wavelengths(385nm ~ 515nm) | LED light, blue and violet wavelengths (390-480nm) 9.7mm light head diameter | **Same, use LED light have same** blue and violet Wavelengths(385nm ~ 515nm) with reference device(K200809) |
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| Comparisons | | Subject device (Curing light, model: M-Cure 6) | Predicate Device (CuringPen Dental Curing Light) | Reference device (D-Lux+) | Reference device LOOP LED Curing Light System (Model: CLK01) | Discussion of difference |
| --- | --- | --- | --- | --- | --- | --- |
| | **Accessories** | Adapter Bracket Light hood | -Charging base -Light source head -Protective light shield -Adapter -Disposable sleeves (1x100pcs) -User Manual Optional accessories: -Light curing depth test board -Protective light glasses | -D-Lux+ Charger -Light Protector -Adapter -Power Cord -Disposable- Sheaths(200ea/Box) -User Manual | LOOP Protective Barrier Sleeves LOOP Protective Light Shield | **Similar, See D4** |
| **Cross Infection Prevent** | | disposable isolation sleeve | Disposable sleeves | Disposable-Sheaths | disposable isolation sleeve | **Similar, See D5** |
| **Composition of patient contacting Materials** | | disposable isolation sleeve: PE | Disposable sleeves: Not public | Disposable-Sheaths: Not public | disposable isolation sleeve: PE | **Similar, See D6** |
| **Technical specification** | **Light Intensity** | Standard mode: -1000 mW/cm², -1500 mW/cm², -2300 mW/cm² | 1) Standard mode: -2300 mW /cm² -1500 mW/cm² -1000 mW/cm² | STD (Standard) mode :900 mW/cm² SFT (Soft Start) mode: 1,300mW/cm² | Repeat Mode: 1000, 1500 and 2000 mW/cm²* Direct Restorative Mode: 1000, 1200 and 1500 mW/cm²** | **Similar, See D7** |
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| Comparisons | | Subject device (Curing light, model: M-Cure 6) | Predicate Device (CuringPen Dental Curing Light) | Reference device (D-Lux+) | Reference device LOOP LED Curing Light System (Model: CLK01) | Discussion of difference |
| --- | --- | --- | --- | --- | --- | --- |
| | | Soft mode: 1000 mW/cm² Pulse mode: 1000 mW/cm² Caries checking mode: 600mW/cm² Ortho mode: 1800 mW/cm² Fast curing mode: 2500 mW/cm² | 2) RAMP mode: 1000 mW/cm² 3) PULSE mode: 1000 mW/cm² 4)Detect mode: 600 mW/cm² | HIG (High Power) mode: 1,300 mW/cm² ORT (Orthodontic) mode:1,800 mW/cm² MAX (Max Power) mode:2400 mW/cm² | Turbo Mode: 2000, 2500 and 3000 mW/cm²** * Relative to lens surface ** Relative to the target surface Device indicates illumination power and time selection | |
| | **wavelength range** | 385nm ~ 515nm | 380-515 nm | 385~515nm | 390~480nm | **Same with reference device D- Lux+(K200809)** |
| | **Peak wavelength** | Dual peak: 405nm, 460nm | Dual peak: 400-410nm, 450-460nm | 405nm, 460nm | Not public | **Same with reference device D- Lux+(K200809)** |
| | **Depth of cure** | ≥2mm | ≥2mm | Not public | Not public | **Same** |
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Justifications for differences between proposed device and the predicate device are shown as below:
| **D1:** | The indications for use of the subject device are the same as for the predicate device CuringPen Dental Curing Light(K221152), except that the CuringPen Dental Curing Light has a wavelength range of 380-515nm per ISO 10650:2018 while the subject device(M-Cure 6), has a wavelength range of 385-515nm, but same with the reference device D-Lux+(K200809) with wavelength range of 385-515nm. **The difference does not raise new question of safety and effectiveness.** |
| --- | --- |
| **D2:** | The subject device is handpiece type using an internal rechargeable lithium ion battery, which is the same as the predicate device CuringPen Dental Curing Light(K221152). The battery power of subject device is similar with predicate device, the subject device can work normally and meet the performance including Light Intensity, Depth of cure under battery power. So the difference doesn't raise new questions of safety and effectiveness. |
| **D3:** | 1.The subject device M-Cure 6 has same Standard mode and PULSE mode with the predicate device CuringPen Dental Curing Light(K221152). 2.The subject device has a **Caries checking mode**, which is functionally equivalent to the **Detect mode** of the predicate device CuringPen Dental Curing Light(K221152). Both are non-curing modes intended for diagnostic purposes. 3. The subject device M-Cure 6 has a Soft mode, while the predicate device has a RAMP mode. Both modes are designed to gradually increase light intensity. And M-Cure 6 has same Soft mode with the reference device D-Lux+(K200809). |
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| | 4. The Fast curing mode of the subject device is functionally equivalent to the MAX (Max Power) mode of the reference device D-Lux+. Both names indicate a mode that provides high-intensity, continuous light output for rapid curing. 5. The subject device M-Cure 6 has Ortho mode, which are same as ORT (Orthodontic) mode of the reference device D-Lux+(K200809). Therefore, the difference does not raise new question of safety and effectiveness. |
| --- | --- |
| **D4:** | The subject device has Adapter, Bracket, and Light hood, while the predicate device CuringPen Dental Curing Light(K221152) has Charging base, Protective light shield, Adapter, Disposable sleeves (1x100pcs), User Manual. The bracket of the subject device is used for holding the device during battery charging, Light hood of the subject device is used to protect dentists from hurting eyes, which have the same functions with charging base, protective light shield of the predicate device CuringPen Dental Curing Light respectively The accessories of the subject device are covered in the predicate device; therefore, the difference does not raise new question of safety and effectiveness. |
| **D5:** | The subject device uses disposable isolation sleeve to prevent cross infection of the patient, which has the same function with the predicate device CuringPen Dental Curing Light(K221152) using the disposable sleeve. The difference does not raise new question of safety and effectiveness. |
| **D6:** | As the subject device uses disposable isolation sleeve to prevent cross infection of the patient, the disposable isolation sleeve contacts with patient, while Disposable-Sheaths of primary devices use contacts with patient. The disposable isolation sleeve of subject device has cleared 510K. Therefore, the difference does not raise new question of safety and effectiveness. |
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| **D7:** | 1. Light Intensity of the subject device M-Cure 6 for standard mode(M1, M2, M3 mode,1000, 1500, 2300mW/cm²),soft mode(1000 mW/cm²), pulse mode(1000 mW/cm²) and caries checking mode(600 mW/cm²), are same with those of the predicate device CuringPen Dental Curing Light(K221152). 2. Light Intensity of the subject device M-Cure 6 for Ortho mode(1800 mW/cm²) is same with the reference device D-Lux+(K200809). 3. Light Intensity of the subject device M-Cure 6 for Fast curing mode(2500 mW/cm²) is a little larger than MAX (Max Power) mode(2400 mW/cm²) of the reference device D-Lux+(K200809), but same with the reference device LOOP LED Curing Light System(K200775). Therefore, the difference does not raise new question of safety and effectiveness. |
| --- | --- |
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## 8. Discussion of Non-Clinical Tests Performed for substantial equivalence are as follows
The device performed performance testing to demonstrate and support substantial equivalence when compared to the predicate and the applicable standards.
| Standards | Standards Name |
| --- | --- |
| ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] | Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance |
| IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION | Medical Electrical Equipment -- Part 1-2: General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests |
| IEC 80601-2-60:2019 | Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment |
| ISO 10650: 2018 | Dentistry - Powered polymerization activators |
| IEC 62471:2006 | Photobiological safety of lamps and lamp systems |
| IEC 62133-2: 2017/AMD1:2021 | Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems |
| IEC 62304:2006+A1:2015 | Medical device software - Software life cycle processes |
| 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 10993-23:2021 | Biological evaluation of medical devices - Part 23: Tests for irritation |
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# ● **Electrical Safety and Electromagnetic Compatibility Testing**
The Device was tested and complied with the applicable requirements of the following standards: ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 80601-2-60 demonstrated that the basic safety and performance of the device met the requirements.
# ● **Biocompatibility Testing**
According to FDA Guidance-Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and ISO 10993-1:2018, we performed the biocompatibility evaluation and test of direct-contacting mucosal membrane components:
(1) In vitro Cytotoxicity test according to ISO 10993-5:2009
(2) Skin Sensitization test according to ISO 10993-10:2021
(3) Irritation test according to ISO 10993-23:2021
The test results verified the device compliance to recognized consensus standards and therefore does not raise new questions of safety and effectiveness.
# ● **Software Verification and Validation**
Software verification and validation was performed, and it was demonstrated that the software performs as intended according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
The test results verified the device compliance to recognized consensus standards and therefore does not raise new questions of safety and effectiveness.
## 9. Concise summary for any performance testing
### 9.1 Summary of Performance testing – bench
The Curing Light (model: M-Cure 6) complies with the performance requirements established by standard ISO 10650:2018. Non-clinical tests performed to establish substantial equivalence to the identified predicate device (K221152) include irradiance over distance testing, peak wavelength testing, and depth of cure testing as suggested by the FDA Guidance Document "Dental Curing Lights – Premarket Notification [510(k)]" issued on March 27, 2006.
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## 9.2 Performance Testing – Animal
Not applicable to this submission for the Curing Light device. The subject of this premarket submission, Curing Light device, did not require animal studies and test results to support substantial equivalence.
## 9.3 Performance Testing – Clinical
Not applicable to this submission for the Curing Light device. The subject of this premarket submission, Curing Light device, did not require clinical studies to support substantial equivalence.
Based on summary of non-clinical tests, the devices meet all the requirement of the standards.
## 10. Substantial Equivalence Conclusion
The Curing Light (model: M-Cure 6) has the same intended use and similar characteristics as the cleared predicate device CuringPen Dental Curing Light.
Moreover, The Curing Light (model: M-Cure 6) meets the safety and performance standards required for Curing Light device, as verified by the bench tests included in this submission, which demonstrate that the differences that existed between M-Cure 6 and CuringPen Dental Curing Light device do not raise any new questions of safety or effectiveness.
Thus, the Curing Light (model: M-Cure 6) is Substantially Equivalent (SE) to the predicate device.
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