Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard LED light curing device with different modes and controls. There is no mention of AI, ML, image processing, or data training/testing, which are typical indicators of AI/ML technology in medical devices.

Therapeutic

No
The device aids in the polymerization of dental materials, which is a restorative process, not a therapeutic one. It hardens materials applied by dental professionals.

Diagnostic

No

The device is described as a light curing polymerization device for dental composites and other materials. Its function is to solidify light-sensitive resins, which is a treatment or fabrication function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components such as a handpiece, cure tip, battery pack, charging base, adapter, and protective sleeve. It is a physical light curing device, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for "light curing polymerization of dental composites, luting materials, cements and other light cured materials." This is a therapeutic or procedural use, not a diagnostic one.
Device Description: The description details a device used to solidify dental materials using light. This is a physical process applied to materials, not a test performed on biological samples to diagnose a condition.
Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing information for diagnosis, monitoring, or screening of diseases or conditions.
Performance Studies: The performance studies focus on safety, electrical standards, and equivalence to a predicate device used for the same purpose, not on diagnostic accuracy metrics like sensitivity, specificity, or AUC.

In summary, the device's function is to cure dental materials, which is a treatment-related activity, not a diagnostic one.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

For light curing polymerization of dental composites, luting materials, cements and other light cured materials.

Product codes

EBZ

Device Description

The LED Curing Light is used for light curing polymerization of dental composites, luting materials, cements and other light cured materials. The device is a cordless pen style, LED light polymerization device for use by dental professionals in dental offices or dental laboratories.

The LED Curing Light protect the handpiece from gross contamination and prevent cross infection between patients by applying the single use protective sleeve. The protective sleeve (patient contact part) is made of PP material.

DB686 NANO:
The LED Curing Light DB686 NANO adopts the principle of ray radiation to solidify the light sensitive resin by shooting at it in a short time. It is composed of handpiece, cure tip, battery pack, charging base, adapter and protective sleeve. The handpiece contains the Rotary switch, Indicator light and Start key.

The LED Curing Light DB686 NANO has one mode namely: Curing light mode.

DB686 SWIFT:
The LED Curing Light DB686 SWIFT adopts the principle of ray radiation to solidify the light sensitive resin by shooting at it in a short time. It is composed of handpiece, cure tip, battery, charging base, adapter and protective sleeve. The handpiece contains the Power/Start button, Mode/ Timer button and LED Display.

The LED Curing Light DB686 SWIFT integrates three modes namely: soft up mode, high power mode and orthodontic mode.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

dental professionals in dental offices or dental laboratories.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ISO 10993-5:2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro A Cytotoxicity
ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
IEC 60601-1:2012 Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
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 80601-2-60:2019 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment;
IEC 62471:2006 Photobiological safety of lamps and lamp systems
IEC 62133-2 Edition1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems

No clinical study is included in this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K200809

Reference Device(s)

K163613

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

December 8, 2022

Foshan COXO Medical Instrument Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, Beijing 102401 China

Re: K220826

Trade/Device Name: LED Curing Light Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator For Polymerization Regulatory Class: Class II Product Code: EBZ Dated: September 9, 2022 Received: September 9, 2022

Dear Ray 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 (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

1

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 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 (QS) 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)

K220826

Device Name

LED Curing Light

Indications for Use (Describe)

For light curing polymerization of dental composites, luting materials, cements and other light cured materials.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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The assigned 510(k) Number:

Tab #6 510(k) Summary

This 510(k) Summary of 510(k) substantial equivalence information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

1. Date of Preparation:2022/11/22
1. Sponsor Identification

Foshan COXO Medical Instrument Co., Ltd.

BLDG 4, District A, Guangdong New Light Source Industrial Base, South of Luocun Avenue, Nanhai District, Foshan, 528226 Guangdong, China.

Contact Person: Yongjian Zheng Position: Legal Representative Tel: +86-13702544788 Fax: +86-757-81800058 Email: 13702544788@163.com

1. Designated Submission Correspondent
  Mr. Ray Wang

Beijing Believe-Med Technology Service Co., Ltd.

Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing, 102401, China

Tel: +86-18910677558 Fax: +86-10-56335780 Email: information@believe-med.com

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4. Identification of Proposed Device

Trade Name: LED Curing Light Common Name: Ultraviolet activator for polymerization

Regulatory Information Classification Name: Ultraviolet activator for polymerization Classification: II Product Code: EBZ Regulation Number: 21 CFR 872.6070 Review Panel: Dental

Indication for use Statement:

For light curing polymerization of dental composites, luting materials, cements and other light cured materials.

Device Description:

The LED Curing Light is used for light curing polymerization of dental composites, luting materials, cements and other light cured materials. The device is a cordless pen style, LED light polymerization device for use by dental professionals in dental offices or dental laboratories.

The LED Curing Light protect the handpiece from gross contamination and prevent cross infection between patients by applying the single use protective sleeve. The protective sleeve (patient contact part) is made of PP material.

DB686 NANO:

The LED Curing Light DB686 NANO adopts the principle of ray radiation to solidify the light sensitive resin by shooting at it in a short time. It is composed of handpiece, cure tip, battery pack, charging base, adapter and protective sleeve. The handpiece contains the Rotary switch, Indicator light and Start key.

The LED Curing Light DB686 NANO has one mode namely: Curing light mode.

DB686 SWIFT:

The LED Curing Light DB686 SWIFT adopts the principle of ray radiation to solidify the light sensitive resin by shooting at it in a short time. It is composed of handpiece, cure tip, battery, charging base, adapter and protective sleeve. The handpiece contains the Power/Start button, Mode/ Timer button and LED Display.

The LED Curing Light DB686 SWIFT integrates three modes namely: soft up mode, high power mode and orthodontic mode.

5

న్. Identification of Predicate Device(s)
Primary Predicate Device 510(k) Number: K200809 Product Name: D-Lux+ Manufacturer: DiaDent Group International

Reference Device: 510(k) Number: K163613 Product Name: Bluephase Style 20i Manufacturer: Ivoclar Vivadent, AG

Non-Clinical Test Conclusion 6.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ISO 10993-5:2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro A Cytotoxicity
ISO 10993-10:2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
IEC 60601-1:2012 Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
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 80601-2-60:2019 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment;
IEC 62471:2006 Photobiological safety of lamps and lamp systems
A IEC 62133-2 Edition1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems
Clinical Test Conclusion 7.

No clinical study is included in this submission.

6

Substantially Equivalent (SE) Comparison 8.

Item	Proposed Device		Predicate Device	Reference Device	Remark
Device name	LED Curing Light		K200809	K163613	/
	DB686 NANO	DB686 SWIFT	D-Lux+	Bluephase Style 20i	/
Device model			D-Lux+	Bluephase Style 20i	/
Classification
Regulation	21 CFR 872.6070		21 CFR 872.6070	21 CFR 872.6070	SAME
Classification	II		II	II	SAME
Product Code	EBZ		EBZ	EBZ	SAME
Common
Name	Ultraviolet activator for polymerization		Ultraviolet activator for
polymerization	Ultraviolet activator for
polymerization	SAME
Indications
for use	For light curing polymerization of dental
composites, luting materials, cements and
other light cured materials.		The D-Lux+ is
intended to polymerize
resinous dental
materials, restorative
composite materials,
and orthodontic
brackets, bonding and
sealing materials that
are photo-polymerized
in the 385~515nm
waveband of visible
light.	With its "Polywave"
broadband spectrum,
Bluephase Style 20i is
suitable for the
polymerization of all
light curing dental
materials curing in the
wavelength range of
385 – 515 nm. These
materials include
restoratives, bonding
agents/adhesives, bases,
liners, fissure sealants,
temporaries, as well as
luting materials for
brackets and indirect
restorations, such as
ceramic inlays.	Equivalent
The proposed
devices,
Reference
Device and the
predicate device
are all indicated
to the
polymerization
of all light curing
dental materials
curing in the
wavelength
range of 385 -
515 nm.
Principles of
operation	1. Clean and
disinfect all the
surfaces of
handpiece and tip
before each use.

Cover the Cure
Tip and handpiece
with the Disposable
Protective Sleeve.
Operate the
rotary switch to
Cure. Press the | 1. Clean and
disinfect all the
surfaces of
handpiece and tip
before each use.
Cover the Cure
Tip and handpiece
with the Disposable
Protective Sleeve.
Select curing
mode and cure
times/ orthodontic | 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 | 1. Disinfect
contaminated surfaces
of the curing light as
well as light probes and
anti-glare cones before
each use.
Make sure that the
stipulated light intensity
permits adequate
polymerization. For that
purpose, check the light
probe for contamination | Different
Analysis (1) |
| | | | | | |
| | Start key to activate
light. Press once or
Double press to
select curing time .
Once the selected
curing time has
elapsed, the curing
program is
automatically
terminated. | cycle(s) .
Short press
Power/Start Button
to start working.
Once the selected
curing time has
elapsed, the curing
program is
automatically
terminated. | light probe for
contamination and
damage, as well as the
light irradiance at
regular intervals.
3.Select curing
program and time.
4.Start: Once the
selected curing time
has elapsed, the curing
program is
automatically
terminated. | and damage, as well as
the light intensity at
regular intervals.
Select curing
program and time
Start: Once the
selected curing time has
elapsed, the curing
program is
automatically
terminated. | |
| Delivery
form content | -Handpiece
-Charging Base
-Cure Tip
-Protection glasses
-Battery pack
-Adapter (with
Power Cord)
-Protective Sleeve
-User Manual | -Handpiece
-Charging Base
-Cure Tip
-Battery (Included
in the handpiece)
-Adapter (with
Power Cord)
-Protective Sleeve
-User Manual | terminated.
-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 | - Charging base with
power cord and
power pack

Handpiece
Light probe
-Anti-glare shield
-Anti-glare cones
-Pack of sleeves
Instructions for use | Different
Analysis (2) |
| Wavelength
range | 385 - 515 nm | | 385 – 515 nm | 385 - 515 nm | SAME |
| Use | Prescription / Hospital | | Prescription / Hospital | Prescription / Hospital | SAME |
| Operational
modes | 1 programs:
Curing light
Mode:10s, 20s
(1600 ~ 1800
mW/cm²) | 3 programs:
Soft up mode: 5s,
10s, 15s, 20s (1600
mW/cm²)
High power mode:
5s (1700 mW/cm²)
Orthodontic
mode:
(1800 mW/cm²) | | High 1,200 mW/cm²
(10, 15, or 20 sec)
Turbo 2,000 mW/cm² (5
Sec) | Different
Analysis (3) |
| Power Supply | Adapter:
100V - 240V- 50 - 60 Hz
Output: 5V 1.5A
Batterycharging | | 100-240VAC, 50-60Hz,
Output: 6VDC/2A
Wirelessly Battery
charging | | Different
Analysis (4) |
| Sterility | Non-sterile | | Non-sterile | Non-sterile | SAME |
| Electrical | IEC 60601-1 | | IEC 60601-1 | IEC 60601-1 | SAME |
| Safety | IEC 60601-1- 2 | IEC 60601-1- 2 | IEC 60601-1- 2 | | |
| Photobiologic
al safety | IEC 62471 | IEC 62471 | / | SAME | |
| Biocompatibility | Direct contact with issue in not intended.
Therefore ISO10993-1 is not applicable. | Direct contact with issue in not intended.
Therefore ISO10993-1 is not applicable. | / | SAME | |
| Infection
Control | Use disposable Protective Sleeve and surface disinfection to prevent cross infection of the Patient . | Use disposable sheath and surface disinfection to prevent cross infection of the patient. | The curing light also is sold with plastic sleeves for infection control. | Equivalent
Analysis (5) | |

Table 1 General Comparison

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Analysis:

Analysis (1):

Although the device design and operational mode between the proposed devices and the predicate device are minor different, they are both complied with IEC60601-1, IEC 60601-1-2 and IEC 62471. The performance of proposed devices complies with IEC80601-2-60. The differences do not affect the safety and effectiveness.

Analysis (2):

The proposed devices use a Cure Tip, the predicate device uses a light guide; the proposed devices provide Protection glasses or recommend wearing Protection glasses for patients, the predicate device provide Light Protector. However, they all can block the blue light radiation outside the application part to protect the operator's eyes from blue light hazards. The performance of proposed devices complies with IEC 62471. The differences do not affect the safety and effectiveness.

Analysis (3):

The light output intensity of the proposed devices (1800 mW/cm² ) is comparable to the Reference Device (2,000 mW/cm²) .The proposed devices have 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. The testing results show that these difference do not affect the safety and effectiveness .

Analysis (4):

The proposed device is charged by the charging method by the 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 5V 1.5A and 6VDC/2A respectively. These difference do not the affect safety and effectiveness.

Analysis (5):

Both the proposed device and predicate device use disposable Protective Sleeve and surface disinfection to prevent cross infection of the patient, and the Disposable Protective Sleeves are complied with ISO 10993-5 , ISO 10993-10 and ISO 10993-11. The proposed device is substantially equivalent to the predicate device.

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Substantially Equivalent (SE) Conclusion 9.
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.