Hi-Light and Hi-Light plus 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 420~490nm 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.

AI/ML Overview

The provided text describes a 510(k) summary for a dental curing light, Hi-Light and Hi-Light Plus. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through extensive clinical trials for new device types. Therefore, the information typically requested for AI/ML device performance studies (like sample sizes for test sets, number of experts for ground truth, MRMC studies, etc.) is not applicable here.

Instead, the acceptance criteria and proof of meeting them for this device are based on non-clinical performance testing and substantial equivalence to predicate devices.

Here's how to extract the relevant information within the context of a 510(k) for a dental curing light:

Acceptance Criteria and Device Performance for Hi-Light / Hi-Light Plus

For a 510(k) submission of a dental curing light, the primary "acceptance criteria" revolve around demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is achieved through comparisons of technological characteristics and performance specifications derived from non-clinical testing against recognized standards.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the specifications of the predicate devices and relevant industry standards. The reported device performance is presented in comparison to these.

Feature / Performance Parameter	Acceptance Criteria (Predicate Devices & Standards)	Reported Device Performance (Hi-Light / Hi-Light Plus)
Intended Use	For light curing polymerization of dental composites, luting materials, cements and other light cured materials.	For light curing polymerization of dental composites, luting materials, cements and other light cured materials. (Identical)
Operating Principle	LED type dental curing light for polymerization of light cure resin based composites, using blue light in the 420-490nm range.	LED type dental curing light for polymerization of light cure resin based composites, using blue light in the 420-490nm range. (Identical)
Light Intensity (Optical Output)	Predicate Range: Bluephase 16i (650-1600 mW/cm²), VALO Cordless (1000-3200 mW/cm²)	Hi-Light: Max 2,000 mW/cm² (±10%) across various modes (Normal: 700 mW/cm², High: 1,400 mW/cm², Turbo: 2,000 mW/cm²). Hi-Light Plus: Max 3,000 mW/cm² (±10%) across various modes (Normal: 1,000 mW/cm², High: 1,600 mW/cm², Extra: 3,000 mW/cm²). (Falls within or provides similar range/functionality to predicates)
Wavelength Range	Predicate: 430-490nm (Bluephase 16i), 395-480nm (VALO Cordless)	430-490nm (Hi-Light, Hi-Light Plus) (Comparable to predicates)
Peak Wavelength	Predicate: 460nm (Bluephase 16i), Unknown (VALO Cordless)	460nm (Hi-Light, Hi-Light Plus) (Comparable where specified)
Depth of Cure	Implied by compliance with ADA/ANSI Specification No. 48 for Visible Light Curing Units, which sets standards for adequate cure depth. Predicate data for specific depth of cure per mode not explicitly provided in table.	Hi-Light: Normal: 5.5mm, High: 5.7mm, Turbo: 4.5mm, Soft Start: 6.3mm, Pulse: 4.9mm. Hi-Light Plus: Normal: 4.6mm, High: 4.4mm, Extra: 5.0mm, Soft Start: 4.5mm, Sequential power: 4.4mm. (Results of non-clinical testing indicating functional depth of cure across modes).
Electrical Safety & EMC	Compliance with IEC 60601-1 (Medical Electrical Equipment - General Requirements for Safety) and IEC 60601-1-2 (Electromagnetic compatibility Requirements).	Compliance with IEC 60601-1: 2005 and IEC 60601-1-2: 2007. (Met)
Biocompatibility	Compliance with ISO 10993-5 (Tests for in vitro cytotoxicity) and ISO 10993-10 (Tests for irritation and skin sensitization) for patient-contacting parts (if applicable, though here it states "FDA cleared barrier sleeve" for direct patient contact).	Compliance with ISO 10993-5:2009/(R) 2014 and ISO 10993-10: 2010. (Met for components if patient contact is direct; however, the primary patient contact is through an FDA cleared barrier sleeve, mitigating direct contact with the device material)
Mechanical/General Performance	Compliance with ADA/ANSI Specification No. 48 and No. 48-2 for Curing Units (Visible Light Curing Units & LED Curing Lights). This standard covers aspects like light output, light homogeneity, beam profile, and other performance characteristics relevant to dental curing lights. This is the primary standard for ensuring the device performs its intended function effectively and safely.	Non-clinical tests performed in accordance with ANSI/ADA Specification No. 48: 2004 and No. 48-2: 2010. The test results met the pre-set criteria. (Met)

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is described as "Non-Clinical Testing" and "Basis for Substantial Equivalence."

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

Sample Size for Test Set: Not applicable in the context of typical AI/ML validation studies. For this device, the "test set" refers to physical units of the Hi-Light and Hi-Light Plus devices themselves that underwent non-clinical performance and safety testing. The document doesn't specify the number of units tested, but it would typically involve a statistically relevant sample from a production batch to ensure consistency.
Data Provenance: The testing was non-clinical (laboratory/bench testing) performed on the physical devices. The document implies this testing was conducted by or for Dentall Corporation in the Republic of Korea, as they are the applicant. The data is thus prospective in that it was generated for this specific regulatory submission.

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

Not applicable in the AI/ML sense. The "ground truth" for a dental curing light's performance (e.g., light intensity, wavelength, depth of cure) is established by using calibrated instruments and adherence to internationally recognized standards (ANSI/ADA, IEC, ISO). The "experts" would be qualified engineers and technicians proficient in conducting these specific tests according to the standards. No human experts are used to interpret images or diagnose conditions in this context.

4. Adjudication Method for the Test Set:

Not applicable. Performance measurements are quantitative and are not subject to human interpretation or adjudication in the way clinical diagnostic studies are. Test results are compared against a numerical specification.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is not a diagnostic device that involves human readers interpreting cases.

6. Standalone (Algorithm Only) Performance:

Not applicable. This is a medical device (hardware) with an intended physical function, not a software algorithm.

7. Type of Ground Truth Used:

Instrumental/Standardized Measurements: The ground truth for performance characteristics (light intensity, wavelength, depth of cure, electrical safety, biocompatibility) is established through highly precise and calibrated measurement equipment and standardized test protocols as defined by ANSI/ADA, IEC, and ISO standards. For example, depth of cure is measured according to the methodology outlined in ADA/ANSI Specification No. 48.

8. Sample Size for the Training Set:

Not applicable. There is no machine learning model involved that requires a "training set." The device is a hardware product.

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

Not applicable, as there is no training set for an algorithm.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized eagle or bird in flight, composed of three overlapping profiles facing to the right.

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

August 3, 2015

Dentall Corporation c/o Ms. Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave. Suite 110 Fullerton, California 92831

Re: K140432

Trade/Device Name: Hi-light, Hi-light Plus Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: July 3, 2015 Received: July 6, 2015

Dear Ms. Chung:

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, 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.

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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 devicerelated 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/ResourcesforYou/Industry/default.htm. 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

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 yours,

Tina
Kiang -S

for Erin I. Keith, M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K140432

Device Name Hi-Light, Hi-Light plus

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)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: 08/03/2015

1. Applicant / Submitter

DENTALL Corporation 301-905 Techno-park, 365 Samjeong-dong, Ojeong-gu, Kyunggi, Republic of Korea 421-741 Tel : +82-32-327-6026 Fax : +82-32-327-6027

2. Submission Contact Person

Priscilla Juhee Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110, Fullerton, CA 92831 Fax: 714-409-3357 Phone: 714.202.5789 Email: juhee.c@lkconsultinggroup.com

3. Device

Trade Name: Hi-Light, Hi-Light plus
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

Primary Predicate Device: Bluephase 16i (K051782) by IVOCLAR VIVADENT, Inc. ●
Reference Predicate Device: VALO Cordless (K110582) by Ultradent Products, Inc. ●

5. Description

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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. Basis for Substantial Equivalence

Hi-Light and Hi-Light plus are substantially equivalent to the Bluephase 16i (K051782) by IVOCLAR VIVADENT, INC and VALO Cordless (K110582) by Ultradent Products, Inc. in terms of intended use, technology and principle of operation. The difference is in different modes but the light intensity (mW/cm²) of the predicate devices encompass the range of the subject device; therefore we determine that this difference in modes do not raise issues of substantial equivalence.

	Subject Device		Primary PredicateDevice	Reference PredicateDevice
Device Name	Hi-Light	Hi-Light plus	Bluephase 16i	VALO Cordless
Manufacturer	DENTALL Corporation	DENTALL Corporation	IVOCLAR VIVADENT,INC	Ultradent Products, Inc.
510(k) number	-	-	K051782	K110582
Product Code	EBZ	EBZ	EBZ	EBZ
Regulatory Class	II	II	II	II
Intended Use	For light curingpolymerization of dentalcomposites, lutingmaterials, cements andother light curedmaterials.	For light curingpolymerization of dentalcomposites, lutingmaterials, cements andother light curedmaterials.	For light curingpolymerization of dentalcomposites, lutingmaterials, cements andother light curedmaterials.	Source of illuminationfor curing photo-activated dentalrestorative materials andadhesives.
Device Design(operational mode1)	Normal Mode1) Optical output: 700mW/cm² (±10%)2) Available timesetting: 10, 15, 20, 30seconds	Normal Mode1) Optical output: 1,000mW/cm² (±10%)2) Available timesetting: 5, 10, 15, 20seconds	Low Power mode1) Optical output: 650mW/cm² (±10%)2) Available timesetting: 10, 20, 30seconds	Standard Power Mode1000mW/cm²
Device Design(operational mode2)	High Mode1) Optical output: 1,400mW/cm² (±10%)2) Available timesetting: 5, 10, 15, 20seconds	High Mode1) Optical output: 1,600mW/cm² (±10%)2) Available timesetting: 3, 5, 10, 15seconds	High Power mode1) Optical output: 1,600mW/cm² (±10%)2) Available timesetting: 5, 10 seconds	High Power Mode1400mW/cm²
Device Design(operational mode3)	Turbo Mode1) Optical output: 2,000mW/cm² (±10%)2) Available timesetting: 3, 5, 10, 15seconds	Extra Mode1) Optical output: 3,000mW/cm² (±10%)2) Available timesetting: 1, 2, 3, 4seconds	-	Xtra Power Mode3200mW/cm²
Device Design(operational mode	Soft Start Mode1) Optical output: After	Soft Start Mode1) Optical output: After	Soft Start Mode1) Optical output: After	-
4)	gradually increasingfrom 0 to 2,000 W/cm²(±10%) and bemaintained until finishtime2) Available timesetting: 10, 15, 20seconds	gradually increasingfrom 0 to 1,600mW/cm² (±10%) and bemaintained until finishtime2) Available timesetting: 5, 10, 15seconds	gradually increasingfrom 0 to 650 mW/cm²(±10%) and jump to1,600 W/cm². It ismaintained until finishtime2) Available timesetting: 10, 15 seconds
Device Design(operational mode5)	Pulse Mode1) Optical output:Repeat 0 and 2,000mW/cm² (±10%)continuously2) Available timesetting: 10, 15, 20seconds	Sequential power Mode1) Optical output: 2,700mW/cm²(±10%). Repeatit 8 times at intervals of2 second.2) Available timesetting: 1, 2, 3, 4seconds
Device Design(light source)	10W LED	10W LED	10W LED	LED
Device Design(power source ofhandpiece)	Rechargeable Li-ionbattery(3.7Vdc)	Rechargeable Li-ionbattery(3.7Vdc)	Rechargeable Li-ionbattery(7.2Vdc)Power pack (12Vdc)	Rechargeable Li-ionbattery(3.2Vdc)
Device Design(power source ofBattery charger)	AC/DC Adapter(Input: 100-240Vac,50/60 Hz,400 mAOutput: 5.0Vdc)	AC/DC Adapter(Input: 100-240Vac,50/60 Hz,400 mAOutput: 5.0Vdc)	AC/DC Adapter(Input: 100-240 Vac, 50-60 Hz, 350 mAOutput 12Vdc)	AC/DC Adapter(Input: 100-240 Vac, 50-60 Hz, 500 mAOutput 12Vdc)
Device Design(accessories)	Handpiece ,Battery charger,Battery pack,Anti- glare shield,Light guide,AC/DC adapter	Handpiece ,Battery charger,Battery pack,Anti- glare shield,Light guide,AC/DC adapter	Handpiece ,Battery charger,Battery pack,Anti- glare shield,Light guide,AC/DC adapter	Handpiece ,Battery charger,Battery pack,Light guide,AC/DC adapter
Chemicalcomposition ofpatient contactingportions of thedevice	FDA cleared barriersleeve	FDA cleared barriersleeve	Glass	FDA cleared barriersleeve
TechnicalSpecifications(light intensity)	Max 2,000 mW/cm²(±10%)	Max 3,000 mW/cm²(±10%)	Max. 1,600 mW/cm²(± 100 mW/cm²)	Max. 3,200 mW/cm²(±20%)
TechnicalSpecifications(wavelength range)	430 ~ 490nm	430 ~ 490nm	430 ~ 490nm	395 ~ 480nm
TechnicalSpecifications(peakwave length)	460nm	460nm	460nm	Unknown
TechnicalSpecifications(depth of cure)	Normal Mode: 5.5mmHigh Mode: 5.7mmTurbo Mode: 4.5mmSoft Start Mode: 6.3mmPulse Mode: 4.9mm	Normal Mode: 4.6mmHigh Mode: 4.4mmExtra Mode: 5.0mmSoft Start Mode: 4.5mmSequential power Mode:4.4mm
Compliance toFDA-RecognizedStandards	IEC 60601-1: 2005IEC 60601-1-2: 2007ADA/ANSISpecification No.48Visible Light	IEC 60601-1: 2005IEC 60601-1-2: 2007ADA/ANSISpecification No.48Visible Light	IEC 60601-1: 2005IEC 60601-1-2: 2007ADA/ANSISpecification No.48Visible Light	IEC 60601-1: 2005IEC 60601-1-2: 2007ADA/ANSISpecification No.48Visible Light

510(k) Submission.

510(k) Summary , 2 / 4 page

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510(k) Submission.

510(k) Summary , 3 / 4 page

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Curing Units,ANSI/ADA StandardNo 48-2 LED CuringLights	Curing Units,ANSI/ADA StandardNo 48-2 LED CuringLights	Curing Units,ANSI/ADA StandardNo 48-2 LED CuringLights	Curing Units,ANSI/ADA StandardNo 48-2 LED CuringLights
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8. Non-Clinical Testing

The non-clinical tests were performed on the subject device in accordance with the following standards and the test results met the pre-set criteria.

American National Standard/American Dental Association (ANSI/ADA) Specification No. 48: 2004
American National Standard/American Dental Association (ANSI/ADA) ● Specification No. 48-2: 2010
. IEC 60601-1: 2005. Medical Electrical Equipment - Part 1: General Requirements for Safety
IEC 60601-1-2: 2007, Medical Electrical Equipment Part 1-2 : General ● Requirements for Safety - Collateral Standard : Electromagnetic compatibilityrequirements
ISO 10993-5:2009/(R) 2014, biological evaluation of medical devices -- part 5: tests ● for in vitro cytotoxicity (Biocompatibility)
ISO 10993-10 Third Edition 2010-08-01, biological evaluation of medical devices -● part 10: tests for irritation and skin sensitization (Biocompatibility)

9. Conclusion

The subject devices and the predicate devices have intended use and have the same technological characteristics. Overall, the Hi-Light and Hi-Light plus have the following similarities to the predicate devices:

- have the same intended use.
- use the same operating principle,
- incorporate the same basic design,
- have similar performance specifications.

Based on the similarities, we conclude that the Hi-Light and Hi-Light plus are substantially equivalent 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.