Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the device's function as an LED light curing unit and mentions no features or components related to AI or ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".

Therapeutic

No
This device is used for polymerization of dental materials, not for therapeutic intervention with a patient.

Diagnostic

No

Explanation: The device is a dental curing light used for polymerization of light-cured dental materials, which is a treatment function, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is an LED-type dental curing light and describes physical components like LEDs, a rechargeable battery, and considerations for lightweight and portability, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

No, 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 describes a process performed on materials used in dental procedures, not on biological samples from a patient to diagnose a condition.
Device Description: The description focuses on the device's function in polymerizing dental materials using light. It doesn't mention analyzing biological samples or providing diagnostic information.
Lack of IVD Indicators: The document does not contain any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health
- Mention of assays, reagents, or laboratory procedures

This device is a dental curing light, which is a medical device used in the treatment of patients, but it does not fit the definition of an In Vitro Diagnostic device.

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 (comma separated list FDA assigned to the subject device)

EBZ

Device 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. They operate on a rechargeable battery, making it easier to carry and use.

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

Not Found

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 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)

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K051782

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K110582

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

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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

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

                                 | Normal Mode

Optical output: 700
mW/cm² (±10%)
Available time
setting: 10, 15, 20, 30
seconds | Normal Mode
Optical output: 1,000
mW/cm² (±10%)
Available time
setting: 5, 10, 15, 20
seconds | Low Power mode
Optical output: 650
mW/cm² (±10%)
Available time
setting: 10, 20, 30
seconds | Standard Power Mode
1000mW/cm² |
| Device Design
(operational mode

                                 | High Mode

Optical output: 1,400
mW/cm² (±10%)
Available time
setting: 5, 10, 15, 20
seconds | High Mode
Optical output: 1,600
mW/cm² (±10%)
Available time
setting: 3, 5, 10, 15
seconds | High Power mode
Optical output: 1,600
mW/cm² (±10%)
Available time
setting: 5, 10 seconds | High Power Mode
1400mW/cm² |
| Device Design
(operational mode

                                 | Turbo Mode

Optical output: 2,000
mW/cm² (±10%)
Available time
setting: 3, 5, 10, 15
seconds | Extra Mode
Optical output: 3,000
mW/cm² (±10%)
Available time
setting: 1, 2, 3, 4
seconds | - | Xtra Power Mode
3200mW/cm² |
| Device Design
(operational mode | Soft Start Mode
Optical output: After | Soft Start Mode
Optical output: After | Soft Start Mode
Optical output: After | - |
| 4) | gradually increasing
from 0 to 2,000 W/cm²
(±10%) and be
maintained until finish
time
Available time
setting: 10, 15, 20
seconds | gradually increasing
from 0 to 1,600
mW/cm² (±10%) and be
maintained until finish
time
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
Available time
setting: 10, 15 seconds | |
| Device Design
(operational mode

                                 | Pulse Mode

Optical output:
Repeat 0 and 2,000
mW/cm² (±10%)
continuously
Available time
setting: 10, 15, 20
seconds | Sequential power Mode
Optical output: 2,700
mW/cm²(±10%). Repeat
it 8 times at intervals of
2 second.
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

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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.