CuringPen Dental Curing Light

K221152 · Changzhou Sifary Medical Technology Co., Ltd. · EBZ · Nov 23, 2022 · Dental

Device Facts

• Record ID: K221152
• Device Name: CuringPen Dental Curing Light
• Applicant: Changzhou Sifary Medical Technology Co., Ltd.
• Product Code: EBZ · Dental
• Decision Date: Nov 23, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 380~515mm waveband of visible light. This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel and not used in the oxygen-rich environment.

Device Story

Cordless, pen-style LED dental curing light; used by qualified dental personnel in hospitals, clinics, or dental offices. Device emits visible light (380-515 nm) to polymerize photo-activated dental materials. Operator selects curing program and time; device automatically terminates upon completion. Includes handpiece, charging base, light source head, protective shield, and disposable sleeves. Provides multiple operational modes (Standard, RAMP, PULSE, Detect) with varying irradiance levels. Healthcare providers use the device to harden restorative materials; ensures proper structural integrity of dental composites and brackets. Benefits patient by enabling efficient, reliable dental restorations.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including irradiance over distance, peak wavelength, depth of cure (≥2mm), and heat generation testing per ISO 10650:2018. Biocompatibility testing (cytotoxicity, sensitization, irritation) per ISO 10993-5/10 confirmed safety. Electrical safety and EMC testing performed per IEC 60601-1 and IEC 60601-1-2.

Technological Characteristics

Cordless pen-style LED light; 3.7V DC Li-ion battery. Wavelength 380-515 nm (dual peak 400-410nm, 450-460nm). Complies with ISO 10650:2018, IEC 80601-2-60:2019, IEC 60601-1, IEC 60601-1-2, IEC 62471, ISO 14971, ISO 10993-5/10. Non-sterile. Software-controlled operation for curing modes.

Indications for Use

Indicated for polymerization of resinous dental materials, restorative composites, orthodontic brackets, and bonding/sealing materials in the 380-515nm waveband. For use by qualified dental personnel in hospital, clinic, or dental office settings. Contraindicated for use in oxygen-rich 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

• D-Lux+ (K200809)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

November 23, 2022

Changzhou Sifary Medical Technology Co., Ltd. % Jie Zhu RA Specialist Changzhou Sifary Medical Technology Co., Ltd No. 99, Qingyang Road, Xuejia County, Xinbei District Changzhou City, Jiangsu Province 213000 China

Re: K221152

Trade/Device Name: CuringPen Dental Curing Light Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator For Polymerization Regulatory Class: Class II Product Code: EBZ Dated: September 23, 2022 Received: September 28, 2022

Dear Jie Zhu:

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 (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 located 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Bobak Shirmohammadi -S

For Michael E. Adjodha, M. ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K221152

Device Name CuringPen Dental Curing Light

Indications for Use (Describe)

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 380~515mm waveband of visible light.

This device must only be used in hospital environments, clinics or dental offices by qualified dental personnel and not used in the oxygen-rich environment.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="text-decoration: overline;">☒</span> Research Use (Part 21 CFR 201.3, subpart D) | ☐ Over-The-Counter Use (21 CFR 201.3, subpart C) |
|-----------------------------------------------------------------------------------------------|--------------------------------------------------|
|-----------------------------------------------------------------------------------------------|--------------------------------------------------|

> Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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# 510(K) Summary K221152

Prepared in accordance with the requirements of 21 CFR Part 807.92

Prepared Date: 2022/09/23

#### 1. Submission Sponsor

Name: Changzhou Sifary Medical Technology Co., Ltd.

Address: No. 99, Qingyang Road, Xuejia County, Xinbei District, Changzhou City, Jiangsu Province, 213000, P.R. China

Contact person: Jie Zhu Title: RA Supervisor

E-mail:[e-mail]

Tel: [phone]

#### Submission Correspondent 2.

Name: Changzhou Sifary Medical Technology Co., Ltd. Address: No. 99, Qingyang Road, Xuejia County, Xinbei District, Changzhou City, Jiangsu Province, 213000, P.R. China Contact person: Jie Zhu E-mail: [e-mail] Tel: [phone]

#### Subject Device 3.

| Trade/Device Name | CuringPen Dental Curing Light |
|---------------------|------------------------------------------|
| Model | CuringPen |
| Common Name | CuringPen Dental Curing Light |
| Regulatory Class | Class II |
| Regulation | 21CFR 872.6070 |
| Classification Name | Ultraviolet activator for polymerization |
| Product code | EBZ |
| Submission type | Traditional 510(K) |

#### Predicate Device 4.

Manufacturer: DiaDent Group International

Device name: D-Lux+

510(K) Number: K200809

#### ട്. Device Description

The CuringPen Dental Curing Light is designed to polymerize all photo-activated dental materials in the wavelength range of 380-515 nm per ISO 10650:2018. 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 and not used

Changzhou Sifary Medical Technology Co., Ltd.

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in the oxygen-rich environment.

#### Indications for Use 6.

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 only be used in hospital environments, clinics or dental offices by qualified dental personnel and not used in oxygen-rich environment.

| Features | Subject Device<br>CuringPen Dental Curing Light | Predicate Device K200809<br>D-Lux+ | Comparison |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| Applicant | Changzhou Sifary Medical<br>Technology Co., Ltd. | DiaDent Group International | / |
| Classification Regulation | 21CRF 872.6070 | 21CRF 872.6070 | Same |
| Classification and Code | Class II<br>EBZ | Class II<br>EBZ | Same |
| Common name | Activator, ultraviolet for<br>polymerization | Activator, ultraviolet for<br>polymerization | Same |
| Indications for use | The CuringPen Dental<br>Curing Light is intended to<br>polymerize resinous dental<br>materials, restorative<br>composite materials, and<br>orthodontic brackets,<br>bonding and sealing<br>materials that are photo-<br>polymerized in the<br>380~515nm waveband of<br>visible light. This device<br>must only be used in<br>hospital environments,<br>clinics or dental offices by<br>qualified dental personnel<br>and not used in oxygen-<br>rich environment. | The D-Lux+ is intended<br>to polymerize resinous<br>dental materials,<br>restorative composite<br>materials, and<br>orthodontic brackets,<br>bonding and sealing<br>materials that are photo-<br>polymerized in the<br>385~515nm waveband<br>of visible light. | Substantially<br>equivalent<br>(SEI) |

| Comparison to the Predicate Device |
|------------------------------------|
|------------------------------------|

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| Features | Subject Device | Predicate Device K200809 | Comparison |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| | CuringPen Dental Curing Light | D-Lux+ | |
| Principles of operation | Step-by-step:<br>1. Disinfect contaminated surfaces of the light source head, protective light shield, handpiece before each use.<br>2. Make sure that the stipulated light irradiance permits adequate polymerization. For that purpose, check the light source head for contamination and damage, as well as the light irradiance at regular intervals.<br>3. Select curing program and time<br>4. Start: Once the selected curing time has elapsed, the curing program is automatically terminated. | Step-by-step:<br>1. Disinfect contaminated surfaces of the curing light as well as light guides and anti-glare cones before each use.<br>2. Make sure that the stipulated light irradiance permits adequate polymerization. For that purpose, check the light probe for contamination and damage, as well as the light irradiance at regular intervals.<br>3. Select curing program and time<br>4. Start: Once the selected curing time has elapsed, the curing program is automatically terminated. | Same |
| Delivery form | -Handpiece<br>-Charging base<br>-Light source head<br>-Protective light shield<br>-Adapter<br>-Disposable sleeves (1x100pcs)<br>-User Manual<br>Optional accessories:<br>-Light curing depth test board<br>-Protective light glasses | -D-Lux+ Handpiece<br>-D-Lux+ Charger<br>-Light Probe<br>-Light Protector<br>-C-Battery (Included in the handpiece)<br>-Adapter<br>-Power Cord<br>-Disposable Sheaths(200ea/Box)<br>-User Manual | Substantially<br>equivalent<br>(SE2) |
| Power source | 3.7V DC with Lithium ion battery<br>5V DC with charger power | 3.6V DC with Lithium ion<br>battery<br>6V DC with charger power | Substantially<br>equivalent<br>(SE3) |
| Light source | LED light | LED light | Same |
| Wavelength range | 380-515 nm | 385-515 nm | Substantially<br>equivalent<br>(see SE1) |
| Peak wavelength | Dual peak:<br>400-410nm, 450-460nm | Dual peak:<br>405nm, 460nm | Substantially<br>equivalent<br>(SE4) |
| Features | Subject Device | Predicate Device K200809 | Comparison |
| | CuringPen Dental Curing Light | D-Lux+ | |
| Operational modes | 1) Standard mode:<br>-2300 mW /cm2<br>-1500 mW/cm2<br>-1000 mW/cm2<br>2) RAMP mode:<br>1000 mW/cm2<br>3) PULSE mode:<br>1000 mW/cm2<br>4) Detect mode:<br>600 mW/cm2 | 1) STD (Standard) mode:<br>900 mW/cm2<br>2) SFT (Soft Start) mode:<br>1300 mW/cm2<br>3) HIG (High Power) mode:<br>1300 mW/cm2<br>4) ORT (Orthodontic) mode:<br>1800 mW/cm2<br>ORT P (Pulse Mode):<br>1800 mW/cm2<br>5) MAX (Max Power):<br>2400 mW/cm2 | Substantially<br>equivalent<br>(SE5) |
| Depth of cure | ≥2mm | ≥2mm | Same |
| Use | Prescription / Hospital | Prescription / Hospital | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Recognized Standards | ISO 10650:2018<br>IEC 80601-2-60:2019<br>IEC 60601-1:2005+A1:2012<br>IEC 60601-1-2:2014<br>IEC 60601-1-6:2010+A1:2013<br>IEC 62471:2006<br>ISO 14971:2019<br>ISO 10993-5:2009<br>ISO 10993-10:2010 | IEC 60601-1:2005+A1:2012<br>IEC 60601-1-2:2014<br>IEC 60601-1-6:2010+A1:2013<br>IEC 62471:2006<br>IEC 62133:2017<br>ISO 14971:2012<br>FCC CFR 47:2008 | Substantially<br>equivalent<br>(SE6) |

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## Justifications for differences between proposed device and the predicate device are shown as below:

SE1: The indications for use of CuringPen Dental Curing Light are the same as for the predicate device, except that the CuringPen Dental Curing Light has a wavelength range of 380-515nm per ISO 10650:2018 while the D-Lux+ has a wavelength range of 385-515nm. The CuringPen Dental Curing Light output is 5nm lower on the bottom end of the range. In both devices the lower wavelength LED is for the purpose of activating the TPO photo-initiator that some resin based composites use. TPO's absorption spectrum is 380-425nm and TPO presents a very high absorption peak located at the 380 nm region. Besides, the indications for use of CuringPen Dental Curing Light emphasize that the device must only be used in hospital environments, clinics or dental offices by qualified dental personnel and not used in oxygen-rich environment. These differences do not affect safety and effectiveness.

SE2: The handpiece (has a built-in battery), charging base, light source head, protective light shield, adapter, disposable sleeves of CuringPen Dental Curing Light 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. CuringPen Dental Curing Light has optional accessories: light curing depth test board and protective light curing depth test board is only used for testing and verifying the depth of cured resin during training process. Protective light glasses provide an additional solution to protect dentists from hurting eyes. These differences have no influence on safety and effectiveness.

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SE3: Both devices use the internal rechargeable lithium ion battery technical specification of CuringPen Dental Curing Light is a bit different from that of the battery of CuringPen Dental Curing Light meets the IEC 62133-2 standard. This difference does not affect safety and effectiveness.

SE4: Both CuringPen Dental Curing Light and D-Lux+ have dual peak wavelength. The peak wavelength of CuringPen Dental Curing Light is described as a range, while the peak wavelength of D-Lux+ is described as given values. The values are similar. This difference does not raise issues of substantial equivalence.

SE5: The CuringPen Dental Curing Light has several modes corresponding to the light output intensity and available times. The light output safety and performance test were conducted according to IEC 60601-1, IEC60601-1-2 and FDA guidance performance testing requirements with the difference. The testing results show that these difference do not affect safety and effectiveness. Besides, the light intensity (mW/cm²) of the predicate device encompass the range of the subject device; therefore we determine that this difference in modes does not raise issues of substantial equivalence.

SE6: The summary of the predicate device states that direct contact with issue in not intended. Therefore ISO10993 series standards are not applicable for D-Lux+. While Curing Light considers the accidental contact and ISO 10993 series standards apply. IEC 62133 is safety standard for battery. CuringPen Dental Curing Light uses batteries which comply with this standards and this can be seen verified in IEC 60601-1 test reports. The predicate device uses wireless charger, thus FCC CFR 47 applies, while the subject device does not use wireless charger. These differences do not raise issues of substantial equivalence.

Therefore, CuringPen Dental Curing Light is substantially equivalent to the predicate device-D-Lux+.

#### Summary of Non-clinical Data 8.

The following non-clinical data were provided in support of the substantial equivalence determination.

## Performance testing:

CuringPen Dental Curing Light complies with the performance requirements established by standard ISO 10650:2018. Non-clinical tests performed to establish substantial equivalence to the identified predicate device (K200809) include irradiance over distance testing, peak wavelength testing, depth of cure testing and heat generation testing as suggested by the FDA Guidance Document "Dental Curing Lights - Premarket Notification [510(k)]" issued on March 27, 2006.

## Biocompatibility testing:

CuringPen Dental Curing Light does not contact with the patient oral tissue on the chance that contact does occur. The light source head of Curing Light, which is covered with the disposable sleeve, may shortly (not exceed 24 hours) contact with the patient oral mucosa unintentionally.

The biocompatibility evaluation of the Curing Light 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 (ISO 10993-5: 2009) .
- Sensitization (ISO 10993-10: 2010) .
- Irritation (Oral mucosa) (ISO 10993-10: 2010) .

Changzhou Sifary Medical Technology Co., Ltd.

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Testing concluded that the test article did not have a cytotoxicity effect, did not elicit sensitization reactions, and did not elicit significant oral mucosa irritation reactions.

## Software verification and validation testing:

Software verification and validation testing were conducted as recommended in IEC 62304:2006+A1:2015 Medical device software - Software life cycle processes and FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for the CuringPen Dental Curing Light was considered as a "moderate" level of concern based on the determination that minor injury could result prior to mitigation of hazards due to software failure.

## Electrical safety and electromagnetic compatibility testing:

The product has been tested to IEC 60601-1-2:2014, IEC 80601-2-60:2019, and ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, and meets the requirements for Electrical Safety, including Electromagnetic Compatibility. The test reports are included in this submission.

#### 9. Summary of Clinical Data

There were no clinical tests performed for the CuringPen Dental Curing Light device.

## 10. Conclusion

Performance testing and compliance with voluntary standards demonstrate that the proposed subject device is substantially equivalent to the predicate device.