(167 days)
No
The device description and performance studies focus on the physical properties and light output of a dental curing light, with no mention of AI or ML capabilities.
No
The device is used for light curing polymerization of dental materials, which is a process that hardens the materials, rather than directly treating a disease or condition.
No
The device is described as a dental curing light used for light curing polymerization of dental materials, which is a treatment function, not a diagnostic one.
No
The device description clearly states it is an LED-type dental curing light, which is a hardware device that emits light for polymerization. It also mentions operating on a rechargeable battery and requiring a barrier sheath, all indicative of a physical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a "dental curing light" used for "light curing polymerization of dental composites, luting materials, cements and other light cured materials." This is a process performed on materials used in dental procedures, not on samples from the human body for diagnostic purposes.
- Intended Use: The intended use is focused on hardening dental materials, not on diagnosing any condition.
The device is a therapeutic/procedural device used in dentistry, not a diagnostic one.
N/A
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
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.
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)
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.
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.
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.
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
§ 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.
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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 that resembles an eagle or a stylized human profile, composed of three overlapping shapes.
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.
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 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
2
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.
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.
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.
| Descriptive
| Information | 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 | ||
| Regulatory | |||||
| Class | 2 | 2 | |||
| Indications for | |||||
| 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. | |||||
| Device Design |
- Operation
Mode
(Standard /
Normal Power
Mode) | 1) Optical
output: 1,200
$mW/cm² (±10%)$
- Available time
setting: 5, 10, 15,
20 seconds | 1) Optical
output: 1,200
$mW/cm² (±10%)$ - Available time
setting: 5, 10, 15,
20 seconds | 1) Optical
output: 800
$mW/cm² (±10%)$ - Available time
setting: 5, 10, 15,
20 seconds | 1) Optical
output: 700
$mW/cm² (±10%)$ - Available time
setting: 10, 15,
20, 30 seconds | 1) Optical
output: 1,000
$mW/cm² (±10%)$ - Available time
setting: 5, 10, 15,
20 seconds |
| Device Design
- Operation
Mode (High /
Fast Power | 1) Optical
output: 1,800
$mW/cm² (±10%)$
- Available time | 1) Optical
output: 2,700
$mW/cm² (±10%)$ - Available time | 1) Optical
output: 1,200
$mW/cm² (±10%)$ - Available time | 1) Optical
output: 1,400
$mW/cm² (±10%)$ - Available time | 1) Optical
output: 1,600
$mW/cm² (±10%)$ - 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
- Operation
Mode (Soft
Start Mode) | 1) Optical
output: After
gradually
increasing from
0 to 1,800
mW/cm²(±10%)
and be
maintained until
finish time
- Available time
setting: 5, 10, 15
seconds | | 1) Optical
output: After
gradually
increasing from
0 to 1,200
mW/cm²(±10%)
and be
maintained until
finish time - Available time
setting: 5, 10, 15
seconds | 1) Optical
output: After
gradually
increasing from
0 to 2,000 W/cm²
(±10%) and be
maintained until
finish time - Available time
setting: 10, 15,
20 seconds | 1) Optical
output: After
gradually
increasing from
0 to 1,600
mW/cm² (±10%)
and be
maintained until
finish time - Available time
setting: 5, 10, 15
seconds |
| Device Design
- Operation
Mode (Pulse /
Sequential
Power Mode) | 1) Optical
output: Repeat 0
and 1,800
mW/cm²
(±10%)
continuously
- Available time
setting: 10, 15,
20 seconds | 1) Optical
output: 2,700
mW/cm²
(±10%). Repeat
it 8 times at
intervals of 2
second. - Available time
setting: 2, 3, 4, 5
seconds | | 1) Optical
output: Repeat 0
and 2,000
mW/cm² (±10%)
continuously - Available time
setting: 10, 15,
20 seconds | 1) 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
- Operation
Mode
(General
Orthodontic /
Turbo Mode) | | | 1) Optical
output: 1,800
mW/cm²(±10%)
- Available time
setting: 2, 4, 6
seconds | 1) Optical
output: 2,000
mW/cm² (±10%) - Available time
setting: 3, 5, 10,
15 seconds | |
| Device Design
- Operation
Mode (Fast
Orthodontic /
Extra Mode) | | | 1) Optical
output: 2,700
mW/cm²(±10%)
- Available time
setting: 1, 2, 3
seconds | | 1) Optical
output: 3,000
mW/cm² (±10%) - Available time
setting: 1, 2, 3, 4
seconds |
| Device Design
- Light source | 10W LED | | | 10W LED | |
| Device Design - Power source
of handpiece | Rechargeable Li-ion battery
(3.7Vdc. 2200mAh) | | | Rechargeable Li-ion battery
(3.7Vdc) | |
| Device Design - Power source
of battery
charger | AC/DC Adapter
(Input: 100-240Vac, 50/60 Hz, 400 mA
Output: 5.0Vdc, 1.6A) | | | AC/DC Adapter
(Input: 100-240Vac, 50/60 Hz, 400
mA
Output: 5.0Vdc) | |
| 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 | |
| Chemical
composition of
patient
contacting
portions of the
device | Disposable sheath
(FDA cleared barrier sheath, K132953/ TIDIShieldTM
Curing Light Sheath) | | | Disposable sheath
(FDA cleared barrier sheath) | |
| Technical
Specifications - Light
intensity | 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%) |
| Technical
Specifications - Wavelength
range | 430 ~ 490nm | | | 430 ~ 490nm | |
| Technical
Specifications - Peak
wavelength- | 460nm | | | 460nm | |
| Compliance to
FDA- | IEC 60601-1:2005 + A1:2012
IEC 60601-1-2:2007 | | | IEC 60601-1:2005
IEC 60601-1-2:2007 | |
| Recognized
Standards | 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.