The MaxCure9 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 Description

This Curing Light is a device which generates high intensity light for polymerization of light curing materials used for dental curing purpose. This curing light is intended for use by trained dental professionals for the purpose of light curing dental resins and composites and used to restore teeth.

AI/ML Overview

The provided text is a 510(k) summary for the MaxCure 9 Curing Light. This document focuses on demonstrating substantial equivalence to a predicate device, not on proving that the device meets specific performance acceptance criteria for an AI/Software as a Medical Device (SaMD) product.

Therefore, the information required to answer your questions about acceptance criteria for AI performance, sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone algorithm performance, is not present in this document.

The document primarily addresses:

Device Description: The MaxCure 9 is a curing light used to polymerize dental materials.
Comparison to Predicate: It compares the MaxCure 9 to the D-Lux+ predicate device, highlighting similarities and differences in features, specifications, and operation.
Performance Data (Non-clinical): It lists the non-clinical tests performed, including biocompatibility, software validation, and electrical safety/EMC standards (e.g., IEC 60601-1, IEC 60601-1-2).
Conclusion: It states that based on the similarities and test results, the device is substantially equivalent to the predicate.

In summary, this document is for a traditional medical device (a curing light), not an AI/SaMD. As such, the information you've requested regarding AI acceptance criteria and study details is not applicable to this specific submission.

Summary

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November 15, 2023

Guilin Refine Medical Instrument Co., Ltd. % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, Guangdong 518067 China

Re: K223414

Trade/Device Name: Curing Light, Model: MaxCure 9 Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator For Polymerization Regulatory Class: Class II Product Code: EBZ Dated: August 14, 2023 Received: August 15, 2023

Dear Kevin Wang:

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.

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"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software

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 OS 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).

Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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 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-reportingcombination-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.

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-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 Shirmoham madi -S

For Michael E. Adjodha, M. ChE., CQIA Assistant Director DHT1B: Division of Dental and

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ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K223414

Device Name Curing Light, Model: MaxCure 9

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
XPrescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Summary

Prepared in accordance with the requirements of 21 CFR Part 807.92

Prepared Date: 2023/11/9

1. Submission sponsor

Name: Guilin Refine Medical Instrument Co., Ltd.

Address: No.8-3, Information Industrial Park, High-Tech Zone, Qixing District, Guilin, GuangXi, China 541004

Contact person: Chen Judong

Title: Management Representative

E-mail: chenjudong(@refine-med.com

2. Submission correspondent

Name: Chonconn Medical Device Consulting Co., Ltd.

Address: Room 504, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P. R. China 518067

Contact person: Kevin Wang E-mail: kevin(@chonconn.com

Tel: +86-755 33941160

Trade/Device Name	Curing Light, Model: MaxCure 9
Model	MaxCure9
Common Name	Curing Light
Regulatory Class	Class II
Classification	21 CFR 872.6070 / Activator, Ultraviolet, For Polymerization / EBZ
Submission type	Traditional 510(K)

3 Subiect Device Information

4. Predicate Device

1. Diadent Group International, D-Lux+ under K200809 (Primary predicate)

Device Description ട്.

Intended use & Indication for use 6.

Section 5 510(k) Summary

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Features	Predicate deviceD-Lux+	Subject deviceCuring Light, Model:MaxCure 9 (K223414)	Note
510(k) number	K200809	\	Same
Product code	EBZ	EBZ	Same
Intended Use &Indications foruse	The D-Lux+ is intended topolymerize resinous dentalmaterials, restorative compositematerials, and orthodonticbrackets, bonding and sealingmaterials that are photo-polymerized in the 385~515nmwaveband of visible light.	The MaxCure9 is intendedto polymerize resinousdental materials, restorativecomposite materials, andorthodontic brackets,bonding and sealingmaterials that are photo-polymerized in the385~515nm waveband ofvisible light.	Same
Principles ofoperation	1. Insert the Light Probe into thehandpiece. Attach the LightProtector to the handpiece.2. Cover the Light Probe with theDisposable Sheath.3. Turn on the power and selectthe mode and set-up time.4. Press the Operation button toperform light irradiation for theset time and press the buttononce again to stop the lightirradiation. The light irradiationprogress time is displayednumerically in the displaywindow.	a) Insert the light guide intothe mounting hole of thecuring light. Clamp andinstall the light hood at theroot of the light guide.b) Cover the Light Guidewith the disposable isolationsleeve.c)Turn on the power andselect the mode and set-uptime.d) Press the mode key toperform light irradiation forthe set time and press thebutton once again to stopthe light irradiation.	Same
Delivery form	-D-Lux+ Handpiece-D-Lux+ Charger-Light Probe-Light Protector-C-Battery (Included in thehandpiece)-Adapter-Power Cord-Disposable Sheaths(200ea/Box)	Main unit,Charger,Light hood,Power adapter,disposable PE isolationsleeve (100ea/Box),Instruction Manual.	Same
Features	Predicate deviceD-Lux+	Subject deviceCuring Light, Model:MaxCure 9	Note
	-User Manual
TechnicalSpecifications –Wavelengthrange	385 – 515 nm	385 – 515 nm	Same
Peakwavelength	Dual peak:405nm, 460nm	Dual peak:400nm, 452 nm	SE, Thevalues aresimilar. Thisdifferencedoes notraise issuesofsubstantialequivalence.
Depth of cure	≥2mm	≥2mm	Same
Lightsource/Probe	a light probe with an embeddedLED	a light probe with anembedded LED	Same
OperationModes andLight Intensity	5 modes:STD (Standard) mode :900 mW/cm²,5, 10, 15 and 20 secondsSFT (Soft Start) mode: 1,300mW/cm²,10 and 15 secondsHIG (High Power) mode: 1,300mW/cm²,5, 10 and 15 secondsORT (Orthodontic) mode: 1,800mW/cm²,3, 4, 5 seconds and PMAX (Max Power) mode:2,400mW/cm²,1, 2 and 3 seconds	2 modes:Turbo mode: 2000 mW/cm2,1S, 3SNormal mode: 1000mW/cm2,5S, 10S, 15S, 20S	Different 1
Cross InfectionPrevent	disposable sheath	disposable PE isolationsleeve	Same
Use	Prescription / Hospital	Prescription / Hospital	Same
Sterility	Non-sterile	Non-sterile	Same
Power Source	rechargeable lithium ion battery	rechargeable lithium ion	Same
Features	Predicate deviceD-Lux+	Subject deviceCuring Light, Model:MaxCure 9	Note
BatteryCharging	wirelessly charged	charging method by thecontact	Different 2
Power supply	100-240VAC, 50-60Hz	100V-240V AC 50Hz/60Hz	Same
outputs	6VDC/2A	DC 5V/1A	Different 2
Electrical Safety	IEC60601-1 and IEC 60601-1-1-2	IEC60601-1 and IEC60601-1-1-2	Same
Chemicalcomposition ofpatientcontactingportions of thedevice	N/A	PE	Different 3
Biocompatibility	Direct contact with issue in notintended. Therefore ISO10993-1is not applicable	ISO 10993-5ISO 10993-10	Different 3

7. Comparison to the Predicate Device

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Different (1): Operation Modes and Light Intensity

The subject device has several modes corresponding to the light output intensity and available times. The light output safety and performance test was conducted according to IEC 60601-1, IEC60601-1-2 and FDA guidance performance testing requirements with the difference. The testing results show that these differences do not affect safety and effectiveness .

Different (2): Battery Charging and Power Supply

The subject device is charged by the charging method of contact. However, the predicate device is wirelessly charged without a contact using a wireless charger. As a power source for the charger, the AC/DC adapter provided by the manufacturer is used. The input specifications of the adapter(100-240VAC, 50-60Hz) are the same, but the outputs differ from each other at 5VDC/1A and 6VDC/2A respectively. These differences do not affect safety and effectiveness . Different (3): Biocompatibility

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.

8. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility testing

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 Curing light was conducted in accordance with the FDA Guidance Section 5 510(k) Summary 5- 5 / 6

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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:

Cytoxicity
Skin Sensitization
Oral Mucosa Irritation

Software Validation

The Curing light software has been fully validated and the device software meets its Design Specifications. FDA Guidance Document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices has been followed in connection with the design of the device.

Non-clinical data

The Curing light has been tested according to the following standards:

ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
IEC 80601-2-60 Edition 2.0 2019-06 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment
ANSI ADA Standard No. 48-2004 (R2015) Visible Light Curing Units

Clinical data

The subject of this premarket submission, Curing light, did not require clinical studies to support substantial equivalence.

9. Conclusion

Based on the similarities in intended use, principles of operation, design rationale, test results, and performance, the subject Curing light is considered to be 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.