(255 days)
No
The summary describes a standard LED curing light with adjustable settings and features, but there is no mention of AI or ML capabilities, image processing, or data-driven performance metrics.
No.
The device is intended to cure dental composites, a mechanical function, and does not directly treat a disease or condition in the body.
No
Explanation: The device is described as a polymerization light intended to cure dental composites, not to diagnose medical conditions.
No
The device description clearly states it is a "hand held LED polymerization light" and a "battery type wireless LED curing light," indicating it is a physical hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is clearly stated as "to cure dental composites using visible light." This is a therapeutic/procedural function performed directly on a patient, not a diagnostic test performed on a sample taken from a patient.
- Device Description: The description details a "hand held LED polymerization light," which is consistent with a device used for curing materials in a dental setting.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
CL-DP40 (Dr's Light PRIME)/CL-DP40 (Dr's Light CHOICE)is a hand held LED polymerization light intended to cure dental composites using visible light.
Product codes
EBZ
Device Description
This unit is a battery type wireless LED curing light. User can adjust light intensity and time by selecting six program modes. Both of Dr's Light PRIME and Dr's Light Choice are characterized by high power intensity, slim head height, large irradiation area (12mm), adjustable intensity power, highly readable color touch screen, 360° twistable head and big capacity of the battery.
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:
- Depth of curing test
- Electrical Safety and EMC tests in accordance with IEC 60601-1 and 60601-1-2
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 4, 2023
Good Doctors Co., Ltd. % Priscilla Chung Regulatory Affairs Consultant Lk Consulting Group USA, Inc. 18881 Von Karman Ave. STE 160 Irvine. California 92612
Re: K223507
Trade/Device Name: CL-DP40 (Dr's Light PRIME), CL-DP40 (Dr's Light CHOICE) Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator For Polymerization Regulatory Class: Class II Product Code: EBZ Dated: June 5, 2023 Received: June 5, 2023
Dear Priscilla 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bobak Shirmohammadi -S
For Michael E. Adjodha, M. ChE., CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
CL-DP40 (Dr's Light PRIME)/ CL-DP40 (Dr's Light CHOICE)
Indications for Use (Describe)
CL-DP40 (Dr's Light PRIME)/CL-DP40 (Dr's Light CHOICE)is a hand held LED polymerization light intended to cure dental composites using visible light.
| 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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K223507
510(k) Summary
This summary of 510(K) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: 11/21/2022
1. Submitter
Good Doctors Co., Ltd. #208, B-dong, 283 Bupyeong-daero, Bupyeong-gu, Incheon 21315, Republic of Korea
2. U.S Agent/Contact Person
Priscilla Chung LK Consulting Group USA, Inc. 18881 Von Karman STE 160, Irvine CA 92612 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device
- . Trade Name: CL-DP40 (Dr's Light PRIME)/ CL-DP40 (Dr's Light CHOICE)
- Common Name: Ultraviolet Activator
- Classification Name: Ultraviolet Activator for Polymerization ●
- Product Code: EBZ ●
- . Classification regulation: 21CFR 872.6070
4. Predicate Device:
- Primary Predicate Device:
- Dr's Light 2 by Good Doctors Co., Ltd. (K173157)
- Reference Predicate Devices: Bluephase by Ivoclar Vivadent (K033520) LED Turbo by Apoza Enterprise Co., Ltd. (K040618)
5. Description:
This unit is a battery type wireless LED curing light. User can adjust light intensity and time by selecting six program modes. Both of Dr's Light PRIME and Dr's Light Choice
4
are characterized by high power intensity, slim head height, large irradiation area (12mm), adjustable intensity power, highly readable color touch screen, 360° twistable head and big capacity of the battery.
6. Indication for use:
CL-DP40 (Dr's Light PRIME)/CL-DP40 (Dr's Light CHOICE)is a hand held LED polymerization light intended to cure dental composites using visible light.
7. Basis for Substantial Equivalence
The subject device CL-DP40 (Dr's Light PRIME) / CL-DP40 (Dr's Light CHOICE) incorporates the same intended use with the predicate devices. The devices are similar in device design and the structure.
The technical specifications between the subject device and the primary predicate device are identical. The difference is that the subject device has 6 modes and the primary predicate device has 7 modes. However, we believe this difference does not raise a questions in safety and performance since the technical specifications between the devices are the same.
| | Subject Device | Primary Predicate
Device | Reference Predicate
Device 1 | Reference Predicate
Device 2 |
|-----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(K) # | N/A | K173157 | K033520 | K040618 |
| Device Name | CL-DP40 (Dr's
Light PRIME)
CL-DP40 (Dr's
Light CHOICE) | Dr's Light 2 | Bluephase | LED Turbo |
| Manufacturer | Good Doctors Co.,
Ltd. | Good Doctors Co.,
Ltd. | Ivoclar Vivadent | Apoza Enterprise Co.,
Ltd. |
| Product Code | EBZ | EBZ | EBZ | EBZ |
| Intended for Use | CL-DP40 (Dr's
Light PRIME)/
CL-DP40 (Dr's
Light CHOICE) is
a hand held LED
polymerization
light intended to
cure dental
composites using
visible light. | Dr's Light 2 is a hand
held LED
polymerization light
intended to cure
dental composites
using visible light. | Bluephase® is a hand
held LED
polymerization light
intended to cure dental
composites using
visible light. | The LED Turbo is a
dental curing light that is
designed for use in the
optic polymerization of
dental resins and
activation of bleaching
materials. |
| Device Design
- Operational
Modes - Light Source
- Power Source
- Wave length
range - Accessories | 1. 6 Modes
- 8W LED
- Battery 3.7V
- 400nm-490nm
(Dr's Light PRIME)
440nm-490nm
(Dr's Light Choice) - Guide Tip,
Shield | 1. 7 Modes - 8W LED
- Battery 3.7V
- 400nm-490nm
- Guide Tip, Shield | 1. 3 Modes
- 8W LED
- Battery 7.2V
- 430nm-490nm
- Guide Tip, Shield | 1. 3 Modes
- 5W LED
- Battery 7.2V
- 440nm-490nm
- Guide Tip, Cone |
| Composition of
Materials | Glass Guide Tip | Glass Guide Tip | Glass Guide Tip | Glass Guide Tip |
5
| Technical
specification
- Light
intensity - Peak
Wavelength - Depth of cure | Max 1600W/cm2
460nm & 405nm
2.3mm(avg.) | Max 1600W/cm2
460nm & 405nm
2.3mm(avg.) | Max 1100mW/cm2
460nm
2.1mm(avg.) | Max 1100mW/cm2
460nm
2.1nm(avg.) |
|--------------------------------------------------------------------------------------------------|-----------------------------------------------|-----------------------------------------------|----------------------------------------|----------------------------------------|
| Electrical Safety | IEC60601-1 | IEC 60601-1 | - | - |
| EMC & EMI | IEC 60601-1-2 | IEC 60601-1-2 | - | - |
8. Non-Clinical Testing
- · Depth of curing test
- Electrical Safety and EMC tests in accordance with IEC 60601-1 and 60601-1-2
9. Conclusion
The subject devices and the predicate device have the same intended use and have the same technological characteristics.
Overall, CL-DP40 (Dr's Light PRIME)/CL-DP40 (Dr's Light CHOICE) has the following similarities to the predicate device:
-
- have the same intended use,
-
- use the same operating principle,
-
- incorporate similar design,
-
- have the same technological characteristics
Based on the similarities, we conclude that the subject device is substantially equivalent to the predicate devices.