Who is the manufacturer of HI-LIGHT, HI-LIGHT PLUS?

Dentall Corporation filed the 510(k) submission for HI-LIGHT, HI-LIGHT PLUS (K140432).

What is the FDA product code for HI-LIGHT, HI-LIGHT PLUS?

EBZ. It is classified under 21 CFR 872.6070 as a Class 2 device in the Dental panel.

What is the regulatory pathway for HI-LIGHT, HI-LIGHT PLUS?

510(k) clearance (submission type: Traditional).

What are the predicate devices for HI-LIGHT, HI-LIGHT PLUS?

Bluephase 16i (K051782); VALO Cordless (K110582).

Who can help prepare an FDA 510(k) submission like HI-LIGHT, HI-LIGHT PLUS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

HI-LIGHT, HI-LIGHT PLUS

K140432 · Dentall Corporation · EBZ · Aug 3, 2015 · Dental

Device Facts

Record ID	K140432
Device Name	HI-LIGHT, HI-LIGHT PLUS
Applicant	Dentall Corporation
Product Code	EBZ · Dental
Decision Date	Aug 3, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.6070
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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

Device Story

Hi-Light and Hi-Light plus are portable, battery-operated LED dental curing lights. Devices emit narrow-spectrum blue light (420-490nm) to activate CPQ molecules in dental monomers, initiating photo-polymerization of resin-based composites, luting materials, and cements. Operated by dental professionals in clinical settings. Handpiece includes rechargeable Li-ion battery, light guide, and anti-glare shield. Multiple operational modes (Normal, High, Turbo/Extra, Soft Start, Pulse/Sequential) allow varying light intensities (up to 3,000 mW/cm²) and exposure times. Clinicians use device to harden restorative materials directly in patient's mouth, facilitating dental procedures.

Clinical Evidence

Bench testing only. Performance verified against ANSI/ADA Specification No. 48 and 48-2. Safety and electromagnetic compatibility tested per IEC 60601-1 and IEC 60601-1-2. Biocompatibility of patient-contacting components (via barrier sleeve) verified per ISO 10993-5 and ISO 10993-10.

Technological Characteristics

LED-based dental curing light; 10W LED source; 430-490nm wavelength range; rechargeable 3.7Vdc Li-ion battery; portable handpiece form factor; uses FDA-cleared barrier sleeves for patient contact; complies with IEC 60601-1, IEC 60601-1-2, and ANSI/ADA Specification No. 48.

Indications for Use

Indicated for light curing polymerization of dental composites, luting materials, cements, and other light-cured materials in dental patients.

Regulatory Classification

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.

Predicate Devices

Bluephase 16i (K051782)
VALO Cordless (K110582)

Related Devices

K070373 — APOZA LED CURING LIGHT, MODEL E-MORLIT, D-2000, TOP 3W, TOP 5W · Apoza Enterprise Co., Ltd. · Mar 2, 2007
K173876 — Cybird LED Curing Light · Dxm Co., Ltd. · Jan 24, 2018
K192233 — LED Curing Light · Foshan Cicada Dental Instrument Co, Ltd. · Feb 13, 2020
K153514 — Premium Plus C01/C02 LED Curing Light · Premium Plus International Limited · Aug 22, 2016
K170529 — Delight, Delight ortho, B&Lite S · Dentall Co., Ltd. · Aug 8, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ #### 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) {3}------------------------------------------------ # 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 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. {4}------------------------------------------------ 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 Predicate Device | Reference Predicate Device | |-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------| | 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 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. | For light curing polymerization of dental composites, luting materials, cements and other light cured materials. | Source of illumination for curing photo- activated dental restorative materials and adhesives. | | Device Design (operational mode 1) | Normal Mode 1) Optical output: 700 mW/cm² (±10%) 2) Available time setting: 10, 15, 20, 30 seconds | Normal Mode 1) Optical output: 1,000 mW/cm² (±10%) 2) Available time setting: 5, 10, 15, 20 seconds | Low Power mode 1) Optical output: 650 mW/cm² (±10%) 2) Available time setting: 10, 20, 30 seconds | Standard Power Mode 1000mW/cm² | | Device Design (operational mode 2) | High Mode 1) Optical output: 1,400 mW/cm² (±10%) 2) Available time setting: 5, 10, 15, 20 seconds | High Mode 1) Optical output: 1,600 mW/cm² (±10%) 2) Available time setting: 3, 5, 10, 15 seconds | High Power mode 1) Optical output: 1,600 mW/cm² (±10%) 2) Available time setting: 5, 10 seconds | High Power Mode 1400mW/cm² | | Device Design (operational mode 3) | Turbo Mode 1) Optical output: 2,000 mW/cm² (±10%) 2) Available time setting: 3, 5, 10, 15 seconds | Extra Mode 1) Optical output: 3,000 mW/cm² (±10%) 2) Available time setting: 1, 2, 3, 4 seconds | - | Xtra Power Mode 3200mW/cm² | | Device Design (operational mode | Soft Start Mode 1) Optical output: After | Soft Start Mode 1) Optical output: After | Soft Start Mode 1) Optical output: After | - | | 4) | gradually increasing from 0 to 2,000 W/cm² (±10%) and be maintained until finish time 2) Available time setting: 10, 15, 20 seconds | gradually increasing from 0 to 1,600 mW/cm² (±10%) and be maintained until finish time 2) Available time setting: 5, 10, 15 seconds | gradually increasing from 0 to 650 mW/cm² (±10%) and jump to 1,600 W/cm². It is maintained until finish time 2) Available time setting: 10, 15 seconds | | | Device Design (operational mode 5) | Pulse Mode 1) Optical output: Repeat 0 and 2,000 mW/cm² (±10%) continuously 2) Available time setting: 10, 15, 20 seconds | Sequential power Mode 1) Optical output: 2,700 mW/cm²(±10%). Repeat it 8 times at intervals of 2 second. 2) Available time setting: 1, 2, 3, 4 seconds | | | | Device Design (light source) | 10W LED | 10W LED | 10W LED | LED | | Device Design (power source of handpiece) | Rechargeable Li-ion battery (3.7Vdc) | Rechargeable Li-ion battery (3.7Vdc) | Rechargeable Li-ion battery (7.2Vdc) Power pack (12Vdc) | Rechargeable Li-ion battery (3.2Vdc) | | Device Design (power source of Battery charger) | AC/DC Adapter (Input: 100-240Vac, 50/60 Hz, 400 mA Output: 5.0Vdc) | AC/DC Adapter (Input: 100-240Vac, 50/60 Hz, 400 mA Output: 5.0Vdc) | AC/DC Adapter (Input: 100-240 Vac, 50- 60 Hz, 350 mA Output 12Vdc) | AC/DC Adapter (Input: 100-240 Vac, 50- 60 Hz, 500 mA Output 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 | | Chemical composition of patient contacting portions of the device | FDA cleared barrier sleeve | FDA cleared barrier sleeve | Glass | FDA cleared barrier sleeve | | Technical Specifications (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%) | | Technical Specifications (wavelength range) | 430 ~ 490nm | 430 ~ 490nm | 430 ~ 490nm | 395 ~ 480nm | | Technical Specifications (peakwave length) | 460nm | 460nm | 460nm | Unknown | | Technical Specifications (depth of cure) | Normal Mode: 5.5mm High Mode: 5.7mm Turbo Mode: 4.5mm Soft Start Mode: 6.3mm Pulse Mode: 4.9mm | Normal Mode: 4.6mm High Mode: 4.4mm Extra Mode: 5.0mm Soft Start Mode: 4.5mm Sequential power Mode: 4.4mm | | | | Compliance to FDA-Recognized Standards | IEC 60601-1: 2005 IEC 60601-1-2: 2007 ADA/ANSI Specification No.48 Visible Light | IEC 60601-1: 2005 IEC 60601-1-2: 2007 ADA/ANSI Specification No.48 Visible Light | IEC 60601-1: 2005 IEC 60601-1-2: 2007 ADA/ANSI Specification No.48 Visible Light | IEC 60601-1: 2005 IEC 60601-1-2: 2007 ADA/ANSI Specification No.48 Visible Light | 510(k) Submission. 510(k) Summary , 2 / 4 page {5}------------------------------------------------ 510(k) Submission. 510(k) Summary , 3 / 4 page {6}------------------------------------------------ | Curing Units, ANSI/ADA Standard No 48-2 LED Curing Lights | Curing Units, ANSI/ADA Standard No 48-2 LED Curing Lights | Curing Units, ANSI/ADA Standard No 48-2 LED Curing Lights | Curing Units, ANSI/ADA Standard No 48-2 LED Curing Lights | |--------------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------| |--------------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------| #### 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.