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 the oxygen-rich environment.

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 in the oxygen-rich environment.

AI/ML Overview

This document describes the premarket notification for the CuringPen Dental Curing Light. The information provided is for a traditional 510(k) submission, demonstrating substantial equivalence to a predicate device, not an AI/ML software device study. Therefore, many of the requested categories related to AI/ML software performance studies are not applicable.

Here's an attempt to answer the questions based on the provided text, indicating "Not Applicable" or "Not Provided" where relevant for AI/ML specific criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (from predicate/standards)	Reported Device Performance (CuringPen Dental Curing Light)
Depth of Cure	≥ 2 mm (Same as Predicate)	≥ 2 mm
Wavelength Range	385-515 nm (Predicate)	380-515 nm
Peak Wavelength	Dual peak: 405nm, 460nm (Predicate)	Dual peak: 400-410nm, 450-460nm
Light output intensity	Sufficient to polymerize materials (Predicate operational modes: 900-2400 mW/cm²)	Offers various modes: 1000, 1500, 2300 mW/cm² (Standard mode), 1000 mW/cm² (RAMP/PULSE), 600 mW/cm² (Detect)
Material Polymerization	Effective polymerization of resinous dental materials	Intended to polymerize resinous dental materials
Biocompatibility	No cytotoxicity, sensitization, or significant irritation (based on ISO 10993 standards)	No cytotoxicity, sensitization, or significant oral mucosa irritation reactions
Electrical Safety	Compliance with IEC 60601-1, IEC 60601-1-2	Complies with IEC 60601-1-2, IEC 80601-2-60, ANSI AAMI ES60601-1
Electromagnetic Compatibility	Compliance with IEC 60601-1-2	Complies with IEC 60601-1-2
Software Verification	Compliance with IEC 62304 and FDA guidance for medical device software	Conducted as recommended, considered "moderate" level of concern
Irradiance over Distance	Not explicitly stated, implied to be sufficient for curing	Testing conducted (results not detailed)

2. Sample Sizes Used for the Test Set and Data Provenance

This is not an AI/ML study involving a test set of data. This is a medical device clearance.

Test Set Sample Size: Not Applicable for an AI/ML test set. The performance testing was conducted on the device itself.
Data Provenance: Not Applicable. The testing was conducted internally or by accredited labs on the physical device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This is not an AI/ML study.

Number of Experts: Not Applicable.
Qualifications of Experts: Not Applicable. Performance was measured against established physical and electrical properties, and biological safety standards.

4. Adjudication Method for the Test Set

This is not an AI/ML study.

Adjudication Method: Not Applicable. Performance was measured objectively against engineering and biological standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

MRMC Study: No, a multi-reader, multi-case comparative effectiveness study was not done. This device is a dental curing light, not an AI/ML diagnostic or assistive tool for human readers.
Effect Size of Human Readers' Improvement with AI: Not Applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

Standalone Study: Not Applicable. This is a physical device, not an algorithm. Performance tests were conducted on the device itself (standalone in terms of being tested independently).

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on established engineering standards, physical measurements, and biological safety standards.

Engineering Standards: ISO 10650:2018 (dental curing lights), IEC 60601 series (electrical safety and EMC).
Biocompatibility Standards: ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization, irritation).
Specific Device Performance: Measured irradiance, wavelength, depth of cure, heat generation.

8. The Sample Size for the Training Set

This is not an AI/ML study.

Training Set Sample Size: Not Applicable. There is no AI/ML model being trained.

9. How the Ground Truth for the Training Set Was Established

This is not an AI/ML study.

Ground Truth for Training Set: Not Applicable.

Summary

{0}------------------------------------------------

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

{1}------------------------------------------------

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K221152

Device Name CuringPen Dental Curing Light

Indications for Use (Describe)

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)
-------------------------------------------------

☒ 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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:amanda@sifary.com

Tel: +86 0519-85962691

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: amanda@sifary.com Tel: +86 0519-85962691

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

Changzhou Sifary Medical Technology Co., Ltd.

{4}------------------------------------------------

in the oxygen-rich environment.

Indications for Use 6.

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 DeviceCuringPen Dental Curing Light	Predicate Device K200809D-Lux+	Comparison
Applicant	Changzhou Sifary MedicalTechnology Co., Ltd.	DiaDent Group International	/
Classification Regulation	21CRF 872.6070	21CRF 872.6070	Same
Classification and Code	Class IIEBZ	Class IIEBZ	Same
Common name	Activator, ultraviolet forpolymerization	Activator, ultraviolet forpolymerization	Same
Indications for use	The CuringPen DentalCuring Light is intended topolymerize resinous dentalmaterials, restorativecomposite materials, andorthodontic brackets,bonding and sealingmaterials that are photo-polymerized in the380~515nm waveband ofvisible light. This devicemust only be used inhospital environments,clinics or dental offices byqualified dental personneland not used in oxygen-rich environment.	The D-Lux+ is intendedto polymerize resinousdental materials,restorative compositematerials, andorthodontic brackets,bonding and sealingmaterials that are photo-polymerized in the385~515nm wavebandof visible light.	Substantiallyequivalent(SEI)

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

{5}------------------------------------------------

Features	Subject Device	Predicate Device K200809	Comparison
	CuringPen Dental Curing Light	D-Lux+
Principles of operation	Step-by-step:1. Disinfect contaminated surfaces of the light source head, protective light shield, handpiece before each use.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.3. Select curing program and time4. Start: Once the selected curing time has elapsed, the curing program is automatically terminated.	Step-by-step:1. Disinfect contaminated surfaces of the curing light as well as light guides and anti-glare cones before each use.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.3. Select curing program and time4. Start: Once the selected curing time has elapsed, the curing program is automatically terminated.	Same
Delivery form	-Handpiece-Charging base-Light source head-Protective light shield-Adapter-Disposable sleeves (1x100pcs)-User ManualOptional accessories:-Light curing depth test board-Protective light glasses	-D-Lux+ Handpiece-D-Lux+ Charger-Light Probe-Light Protector-C-Battery (Included in the handpiece)-Adapter-Power Cord-Disposable Sheaths(200ea/Box)-User Manual	Substantiallyequivalent(SE2)
Power source	3.7V DC with Lithium ion battery5V DC with charger power	3.6V DC with Lithium ionbattery6V DC with charger power	Substantiallyequivalent(SE3)
Light source	LED light	LED light	Same
Wavelength range	380-515 nm	385-515 nm	Substantiallyequivalent(see SE1)
Peak wavelength	Dual peak:400-410nm, 450-460nm	Dual peak:405nm, 460nm	Substantiallyequivalent(SE4)
Features	Subject Device	Predicate Device K200809	Comparison
	CuringPen Dental Curing Light	D-Lux+
Operational modes	1) Standard mode:-2300 mW /cm2-1500 mW/cm2-1000 mW/cm22) RAMP mode:1000 mW/cm23) PULSE mode:1000 mW/cm24) Detect mode:600 mW/cm2	1) STD (Standard) mode:900 mW/cm22) SFT (Soft Start) mode:1300 mW/cm23) HIG (High Power) mode:1300 mW/cm24) ORT (Orthodontic) mode:1800 mW/cm2ORT P (Pulse Mode):1800 mW/cm25) MAX (Max Power):2400 mW/cm2	Substantiallyequivalent(SE5)
Depth of cure	≥2mm	≥2mm	Same
Use	Prescription / Hospital	Prescription / Hospital	Same
Sterility	Non-sterile	Non-sterile	Same
Recognized Standards	ISO 10650:2018IEC 80601-2-60:2019IEC 60601-1:2005+A1:2012IEC 60601-1-2:2014IEC 60601-1-6:2010+A1:2013IEC 62471:2006ISO 14971:2019ISO 10993-5:2009ISO 10993-10:2010	IEC 60601-1:2005+A1:2012IEC 60601-1-2:2014IEC 60601-1-6:2010+A1:2013IEC 62471:2006IEC 62133:2017ISO 14971:2012FCC CFR 47:2008	Substantiallyequivalent(SE6)

{6}------------------------------------------------

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.

{7}------------------------------------------------

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.

{8}------------------------------------------------

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.

Regulation Number and Section

§ 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.