Delight, Delight ortho and B&Lite S are light-emitting diode (LED) type dental curing light that is used for polymerization of light cure resin based composites. They can be used on several different dental materials that are curable by light. The devices use LED that produce a narrow spectrum of blue light in the 430~490nm range, which is useful energy range for activating the CPQ molecule, most commonly used to initiate the photo polymerization of dental monomers. The devices are designed by considering lightweight and portability. They operate on a rechargeable battery, making it easier to carry and use.

The device is not provided sterile and is not intended to be sterilized when used. To prevent cross contamination, users must cover the device with FDA cleared barrier sheath (K132953/ TIDIShield™ Curing Light Sheath). It should be changed between each patient.

AI/ML Overview

This document describes the non-clinical testing performed for the "Delight, Delight ortho, and B&Lite S" dental curing lights to demonstrate their substantial equivalence to a predicate device (Hi-Light, Hi-Light plus, K140432).

1. Table of Acceptance Criteria and Reported Device Performance

The main acceptance criteria are based on recognized standards for dental curing lights, specifically ANSI/ADA Specification No. 48 and ANSI/ADA Standard No. 48-2, as well as FDA guidance. The document highlights differences in operation modes and light intensity, and depth of cure between the subject devices and the predicate, stating that testing confirmed these differences did not raise safety and performance issues.

Acceptance Criteria / Standard	Device Performance (Testing results according to standards)
Product Code and Regulatory Classification	Consistent with predicate (Class 2, Product Code EBZ)
Indications for Use	Consistent with predicate (light curing polymerization of dental composites, luting materials, cements and other light cured materials)
Principle of Operation	Consistent with predicate (LED type cordless dental curing light, 430-490nm blue light spectrum, activating CPQ molecule)
Light Source	Consistent with predicate (10W LED, 430-490nm wave range, 460nm peak wavelength)
Power Source	Consistent with predicate (Rechargeable Li-ion battery, AC/DC Adapter charger)
Chemical composition of patient contacting portions	Consistent with predicate (Disposable sheath: FDA cleared barrier sheath, K132953/TIDIShield™ Curing Light Sheath)
Operation Modes and Light Intensity (IEC 60601-1, ANSI/ADA specification no.42, ANSI/ADA specification no. 42-2, FDA guidance)	"The testing results show that these differences do not raise any problems in the safety and performance." Precise numerical results for each mode and device (Delight, Delight Ortho, B&Lite S) are detailed in the comparison table, showing they meet safety and performance.
Depth of Cure (ANSI/ADA specification no.42, ANSI/ADA specification no. 42-2, FDA guidance)	"The testing results show that these differences do not raise any problems in the safety and performance." Specific depth of cure values are correlated to operation modes, indicating successful performance.
Electrical Safety (IEC 60601-1:2005+A1:2012, AAMI/ANSI ES 60601-1: 2005+A1: 2012)	"The test results conformed to the standards."
Electromagnetic Compatibility (IEC 60601-1-2: 2007)	"The test results conformed to the standards."
Irradiation (Optical Power Testing) (ANSI/ADA Spec. No. 48, 48-2, FDA Guidance)	"The test results conformed to the requirements of the standards."
Spectral Irradiance Plot (Wavelength Spectrum Testing) (ANSI/ADA Spec. No. 48, 48-2, FDA Guidance)	"The test results conformed to the requirements of the standards."
Depth of Cure (Composite Hardness Testing) (ANSI/ADA Spec. No. 48, 48-2, FDA Guidance)	"The test results conformed to the requirements of the standards."

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

The document does not explicitly state the sample size for the test set. It refers to "testing results" and "performance testing - nonclinical testing" without providing specific numbers of units or measurements.

The data provenance is from non-clinical testing conducted according to international (IEC) and national (US: ANSI/ADA, FDA Guidance) standards. The country of origin of the data is not explicitly stated as it's a non-clinical test, but the applicant (DENTALL Co., Ltd.) is from Korea, suggesting the testing was likely overseen or conducted there or by a recognized testing facility acting on their behalf. The data is prospective in nature, as it was generated specifically for this premarket notification.

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

Since this is a non-clinical performance study of a device (dental curing light) assessing its physical properties and adherence to technical standards, the "ground truth" is established by adherence to predefined technical specifications and standards (e.g., optical power, wavelength, depth of cure, electrical safety). This type of study does not typically involve human experts establishing "ground truth" in the diagnostic sense (like for medical image interpretation). Instead, the "truth" is determined by calibration and measurement instruments and protocols.

4. Adjudication Method for the Test Set

Not applicable. As this is a non-clinical performance study based on objective measurements against engineering standards, an adjudication method for conflicting expert opinions is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

Not applicable. This is a submission for a dental curing light, which is a physical device, not an AI-based diagnostic aid. No MRMC study was performed.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done

The performance testing described is for the device in a standalone capacity, measuring its direct output and effect (e.g., optical power, wavelength, depth of cure). This could be considered analogous to "algorithm only" performance in that it evaluates the device's intrinsic functional specifications.

7. The Type of Ground Truth Used

The ground truth used for these non-clinical tests is based on defined technical specifications and measurement criteria outlined in relevant standards:

IEC 60601-1 (Electrical Safety)
IEC 60601-1-2 (Electromagnetic Compatibility)
ANSI/ADA Specification No. 48 (Visible Light Curing Units)
ANSI/ADA Standard No. 48-2 (LED Curing Lights)
FDA Guidance for Industry and FDA Staff, Dental Curing Lights - Premarket Notification - 510(k) Submissions

These standards provide the benchmarks for acceptable performance and safety.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."

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

Not applicable. As there is no training set.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

DENTALL Co., Ltd c/o DongHa Lee KMC, Inc. Room no., 904, 27, Digital-ro 27ga-gil, Guro-gu Seoul 08375 KOREA

August 8, 2017

Re: K170529

Trade/Device Name: Delight, Delight Ortho, B&Lite S Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet activator for polymerization Regulatory Class: Class II Product Code: EBZ Dated: June 23, 2017 Received: July 5, 2017

Dear DongHa Lee:

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. The general controls provisions of the Act include requirements for annual registration. Isting 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.

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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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mary S. Runner -S

Michael Ryan Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Change Control Table, Change History

Change Control Table

Version	Document Author	Document Approver	Date Approved
1.00	Name, Title, Office	Name, Title, Office	MM/DD/YYYY

Complete Change Control Table (all versions) retained in SWIFT Docs.

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Indications for Use

510(k) Number (if known) K170529

Device Name Delight, Delight ortho, B&Lite S

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

|X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/4/Picture/0 description: The image shows the logo for "Dentalall". The word "Dental" is written in bold, black letters, with a light purple swoosh above it. The "all" portion of the logo is in white letters inside of a green parallelogram.

510(k) Summary (K170529)

Date: August 9, 2017

1. Applicant / Submitter

DENTALL Co., Ltd.

Address: 301-905, Bucheontechnopark, 345, Seokcheon-ro, Ojeong-gu, Bucheon-si, Gyeonggi-do, 14501, Korea

Tel: +82-32-327-6026 Fax: +82-32-327-6027

Establishment registration number: 3009307635

2. Submission Contact Person

DongHa Lee (Consultant / KMC, Inc.) Address: Room no. 904, 27, Digital-ro 27ga-gil, Guro-gu, Seoul, 08375, Korea Tel: +82-70-8965-5554 Fax: +82-2-2672-0579 Email: dhlee@kmcerti.com

3. Device Information

· Trade Name: Delight, Delight ortho, B&Lite S
Common Name: Dental curing light
Device Classification: Class II
Classification Name: Ultraviolet activator for polymerization .
Product Code: EBZ
Classification regulation: 21CFR 872.6070

4. Predicate Device

· Hi-Light, Hi-Light plus (K140432) by DENTALL Co., Ltd.

5. Device Description

Delight, Delight ortho and B&Lite S are light-emitting diode (LED) type dental curing light that is

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Image /page/5/Picture/0 description: The image shows the logo for "Dentall". The word "Dentall" is written in a bold, sans-serif font. The "Dent" part of the word is in black, while the "all" part is in white against a green parallelogram. There is a light purple swoosh design to the left of the word.

used for polymerization of light cure resin based composites. They can be used on several different dental materials that are curable by light. The devices use LED that produce a narrow spectrum of blue light in the 430~490nm range, which is useful energy range for activating the CPQ molecule, most commonly used to initiate the photo polymerization of dental monomers. The devices are designed by considering lightweight and portability. They operate on a rechargeable battery, making it easier to carry and use.

6. Indication for use

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

7. Substantial Equivalence

Delight, Delight ortho and B&Lite S are substantially equivalent to the predicate devices, Hi-Light, Hi-Light plus (K140432) by DENTALL Co., Ltd. in terms of intended use, technology and principle of operation.

The following comparison table is presented to demonstrate substantial equivalence.

DescriptiveInformation	Subject Device			Predicate Device
Device Name	Delight	Delight ortho	B&Lite S	Hi-Light	Hi-Light plus
Manufacturer	DENTALL Co., Ltd.			DENTALL Co., Ltd.
510(k) number	-			K140432
Product Code	EBZ			EBZ	EBZ
RegulatoryClass	2			2
Indications foruse	For light curing polymerization of dental composites,luting materials, cements and other light cured materials.			For light curing polymerization ofdental composites, luting materials,cements and other light curedmaterials.
Device Design- OperationMode(Standard /Normal PowerMode)	1) Opticaloutput: 1,200$mW/cm² (±10%)$2) Available timesetting: 5, 10, 15,20 seconds	1) Opticaloutput: 1,200$mW/cm² (±10%)$2) Available timesetting: 5, 10, 15,20 seconds	1) Opticaloutput: 800$mW/cm² (±10%)$2) Available timesetting: 5, 10, 15,20 seconds	1) Opticaloutput: 700$mW/cm² (±10%)$2) Available timesetting: 10, 15,20, 30 seconds	1) Opticaloutput: 1,000$mW/cm² (±10%)$2) Available timesetting: 5, 10, 15,20 seconds
Device Design- OperationMode (High /Fast Power	1) Opticaloutput: 1,800$mW/cm² (±10%)$2) Available time	1) Opticaloutput: 2,700$mW/cm² (±10%)$2) Available time	1) Opticaloutput: 1,200$mW/cm² (±10%)$2) Available time	1) Opticaloutput: 1,400$mW/cm² (±10%)$2) Available time	1) Opticaloutput: 1,600$mW/cm² (±10%)$2) Available time
Mode)	setting: 3, 6, 9,12 seconds	setting: 2, 3, 5,10 seconds	setting: 3, 6, 9,12 seconds	setting: 5, 10, 15,20 seconds	setting: 3, 5, 10,15 seconds
Device Design- OperationMode (SoftStart Mode)	1) Opticaloutput: Aftergraduallyincreasing from0 to 1,800mW/cm²(±10%)and bemaintained untilfinish time2) Available timesetting: 5, 10, 15seconds		1) Opticaloutput: Aftergraduallyincreasing from0 to 1,200mW/cm²(±10%)and bemaintained untilfinish time2) Available timesetting: 5, 10, 15seconds	1) Opticaloutput: Aftergraduallyincreasing from0 to 2,000 W/cm²(±10%) and bemaintained untilfinish time2) Available timesetting: 10, 15,20 seconds	1) Opticaloutput: Aftergraduallyincreasing from0 to 1,600mW/cm² (±10%)and bemaintained untilfinish time2) Available timesetting: 5, 10, 15seconds
Device Design- OperationMode (Pulse /SequentialPower Mode)	1) Opticaloutput: Repeat 0and 1,800mW/cm²(±10%)continuously2) Available timesetting: 10, 15,20 seconds	1) Opticaloutput: 2,700mW/cm²(±10%). Repeatit 8 times atintervals of 2second.2) Available timesetting: 2, 3, 4, 5seconds		1) Opticaloutput: Repeat 0and 2,000mW/cm² (±10%)continuously2) Available timesetting: 10, 15,20 seconds	1) Opticaloutput: 2,700mW/cm²(±10%). Repeatit 8 times atintervals of 2second.2) Available timesetting: 1, 2, 3, 4seconds
Device Design- OperationMode(GeneralOrthodontic /Turbo Mode)			1) Opticaloutput: 1,800mW/cm²(±10%)2) Available timesetting: 2, 4, 6seconds	1) Opticaloutput: 2,000mW/cm² (±10%)2) Available timesetting: 3, 5, 10,15 seconds
Device Design- OperationMode (FastOrthodontic /Extra Mode)			1) Opticaloutput: 2,700mW/cm²(±10%)2) Available timesetting: 1, 2, 3seconds		1) Opticaloutput: 3,000mW/cm² (±10%)2) Available timesetting: 1, 2, 3, 4seconds
Device Design- Light source	10W LED			10W LED
Device Design- Power sourceof handpiece	Rechargeable Li-ion battery(3.7Vdc. 2200mAh)			Rechargeable Li-ion battery(3.7Vdc)
Device Design- Power sourceof batterycharger	AC/DC Adapter(Input: 100-240Vac, 50/60 Hz, 400 mAOutput: 5.0Vdc, 1.6A)			AC/DC Adapter(Input: 100-240Vac, 50/60 Hz, 400mAOutput: 5.0Vdc)
Device Design- Accessories	Handpiece , Battery charger, Battery pack, Anti- glareshield, Light guide, AC/DC adapter			Handpiece , Battery charger,Battery pack, Anti- glare shield,Light guide, AC/DC adapter
Chemicalcomposition ofpatientcontactingportions of thedevice	Disposable sheath(FDA cleared barrier sheath, K132953/ TIDIShieldTMCuring Light Sheath)			Disposable sheath(FDA cleared barrier sheath)
TechnicalSpecifications- Lightintensity	Max.1,800mW/cm²(±10%)	Max.2,700mW/cm²(±10%)	Max.2,700mW/cm²(±10%)	Max.2,000mW/cm²(±10%)	Max.3,000mW/cm²(±10%)
TechnicalSpecifications- Wavelengthrange	430 ~ 490nm			430 ~ 490nm
TechnicalSpecifications- Peakwavelength-	460nm			460nm
Compliance toFDA-	IEC 60601-1:2005 + A1:2012IEC 60601-1-2:2007			IEC 60601-1:2005IEC 60601-1-2:2007
RecognizedStandards	ADA/ANSI Specification No.48,ANSI/ADA Standard No. 48-2			ADA/ANSI Specification No.48,ANSI/ADA Standard No 48-2

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Image /page/6/Picture/0 description: The image shows the logo for "Dentall". The word "Dental" is in bold, black font, with a light purple swoosh above the "D". To the right of "Dental" is the word "all" in white font, set against a green parallelogram.

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Image /page/7/Picture/0 description: The image shows the logo for "Dentall". The word "Dental" is written in a bold, black font. The "all" portion of the word is written in a light green color and is slanted to the right. There is a light purple shadow behind the word "Dental".

7.1 The same between the subject device and the predicate devices.

Product Code and Regulatory Classification

: The proposed classification of the subject devices is 2 according to the product code, EBZ. It is the same as the predicate devices (K140432).

2) Indications for Use

: The proposed indications for use of the subject devices is for light curing polymerization of dental composites, luting materials, cements and other light cured materials. It is the same as the predicate devices (K140432).

3) Principle of Operation

: The subject devices are light-emitting diode (LED) type cordless dental curing light that produce a narrow spectrum of blue light in the 430~490nm range, which is useful energy range for activating the CPQ molecule, most commonly used to initiate the photo polymerization of dental monomers. It is the same as the predicate devices (K140432).

Light Source

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Image /page/8/Picture/0 description: The image shows the logo for "Dentall". The word "Dentall" is written in a bold, sans-serif font. The "Dent" portion of the word is in black, while the "all" portion is in white against a green parallelogram. There is a light purple swoosh above the word "Dent".

: The subject device uses 10W LED that produce a narrow spectrum of blue light in the 430~490nm wave range and 460nm peak wavelength. It is the same as the predicate devices (K140432).

Power Source

: The subject device is handpiece type using an internal rechargeable lithium ion battery (3.7Vdc. 2200mAh) and a battery charger (AC/DC Adapter, Input: 100-240Vac, 50/60 Hz, 400 mA Output: 5.0Vdc, 1.6A) is provided by manufacturer. It is the same as the predicate devices (K140432).

Chemical composition of patient contacting portions of the device

: The subject device uses a disposable sheath (FDA cleared barrier sheath, K132953/TIDIShiela™ Curing Light Sheath). It is the same as the predicate devices (K140432).

7.2 Differences between Subject Devices and Predicates Devices

Operation Modes and Light Intensity

: The subject 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, ANSI/ADA specification no.42, ANSI/ADA specification no. 42-2 and FDA guidance performance testing requirements with the difference. The testing results show that these difference do not raise any problems in the safety and performance.

2) Depth of cure

: The subject devices specify several depth of cure corresponding to the operation mode. The depth of cure was evaluated according to ANSI/ADA specification no.42, ANSI/ADA specification no. 42-2 and FDA guidance performance testing requirements with the difference. The testing results show that these difference do not raise any problems in the safety and performance.

8. Electrical Safety and Electromagnetic compatibility

The Electrical Safety and Electromagnetic compatibility tests were performed in accordance with the following standards.

IEC 60601-1:2005+A1:2012 and US Deviation (AAMI/ANSI ES 60601-1: 2005+A1: 2012), -Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
-IEC 60601-1-2: 2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests

The test results conformed to the standards.

9. Performance Testing - Nonclinical Testing

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Image /page/9/Picture/0 description: The image shows the logo for Dentalall. The word "Dental" is written in a bold, black font, with a light purple swoosh above it. The word "all" is written in a green box that is tilted to the right.

The following non-clinical tests were conducted to evaluate the functionality, performance and substantial equivalence.

-Irradiation (Optical Power Testing)
Spectral irradiance plot (Wavelength Spectrum Testing) -
-Depth of cure (Composite Hardness Testing)

The tests are in accordance with the following standards.

American National Standard/American Dental Association (ANSI/ADA) Specification No. 48: -2004, Reaffirmed 2015, Visible Light Curing Units
-American National Standard/American Dental Association (ANSI/ADA) Specification No. 48-2: 2010, Reaffirmed 2015, LED Curing Lights
FDA Guidance for Industry and FDA Staff, Dental Curing Lights -Premarket Notification -510(k) Submissions, Clause 8. Performance Specifications

The test results conformed to the requirements of the standards.

10. Conclusion

In comparing between the subject devices and the predicate devices, there are the same product code, regulatory classification, indications for use, principle of operation, light source, power source, and chemical composition of patient contacting portions. Safety and performance testing supports substantial equivalence of the subject device to the predicate devices.

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.