(248 days)
No
The summary describes a standard LED curing light with different modes and materials, with no mention of AI or ML capabilities.
No.
The device is intended to polymerize dental materials, not to treat a disease, injury, or condition in a patient.
No
Explanation: The device is a dental curing light intended to polymerize resinous dental materials. It does not measure, analyze, or interpret data to diagnose a condition or disease.
No
The device description explicitly states the device has a body made from industrial-grade aluminum and features multiple curing modes, indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "polymerize resinous dental materials, restorative composite materials and orthodontic brackets, bonding and sealing materials that are photo-polymerized in the 400-480 nm waveband of visible light." This describes a device used to cure materials applied to the patient, not a device used to test samples from the patient.
- Device Description: The description focuses on the physical characteristics and function of a light-emitting device used in dental procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely therapeutic/procedural in nature, not diagnostic.
N/A
Intended Use / Indications for Use
The Cybird LED Curing Light is intended to polymerize resinous dental materials, restorative composite materials and orthodontic brackets, bonding and sealing materials that are photo-polymerized in the 400-480 nm waveband of visible light.
Product codes
EBZ
Device Description
Cybird is a LED curing light intended for polymerization of light-cured materials by dental professionals. This product is effective on various light-cured materials. Cybird's body is made from industrial-grade aluminum which is a durable material intended to ensure heat dissipation. The Cybird features multiple curing modes to ensure functionality.
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)
Verification activities included curing hardness, depth of cure per ADA Specification No. 48.
Performance testing: Irradiance intensity test and spectral irradiance output were tested for both devices for comparison. The performance test results demonstrated that the Cybird WPT LED Curing light performed similar or better compared with the predicate device.
Biocompatibility: Cybird WPT LED Curing Light is manufactured with identical materials as the 510(k) cleared light curing units, the Cybird LED curing Light (Model: Gold & XD, K173876). All materials to be connected to the patient's skin are in conformity with AAMI / ANSI / ISO 10993-5:2009/(R) 2014, Biological Evaluation of Medical Devices-- Part 5: Tests for In Vitro Cytotoxicity (L929 Assay) and AAMI / ANSI / ISO 10993-10:2010, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
Electrical Safety and EMC essential performance testing was conducted in accordance with - AAMI ANSI ES 60601-1:2005/(R) 2012 and A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD). - IEC 60601-1-2 Ed.3: 2007-03 Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.
Software: Software verification and validation testing as recommended in IEC62304:2006 Medical device software - Software life cycle processes and FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005).
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
January 10, 2020
DXM Co., Ltd % Dave Kim President Mtech Group 8310 Buffalo Speedway Houston, Texas 77025
Re: K191221
Trade/Device Name: Cybird LED Curing Light Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: Class II Product Code: EBZ Dated: November 29, 2019 Received: December 11, 2019
Dear Dave Kim:
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.
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 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,
for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental 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) K191221
Device Name Cybird LED Curing Light Model: Cybird WPT
Indications for Use (Describe)
The Cybird LED Curing Light is intended to polymerize resinous dental materials, restorative composite materials and orthodontic brackets, bonding and sealing materials that are photo-polymerized in the 400-480 nm waveband of visible light.
| 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) |
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Image /page/3/Picture/0 description: The image shows the DXM logo. The logo consists of a green curved shape on the left and the letters "dxm" in blue on the right. The green shape is abstract and appears to be a stylized leaf or wave. The letters "dxm" are in lowercase and have a slightly blurred or faded appearance.
510(k) Summarv
This summary of 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date 510k summary prepared:
December 6, 2019
+713-467-2607
I. SUBMITTER
Submitter's Name Submitter's Address
Submitter's Telephone
Submitter's Fax
Contact person
DXM Co., Ltd. Baekseok-dong, Ilsan technotown 1003, 138, Ilsan-ro, Ilsandong-gu Goyang-si, Gyeonggi-do, Republic of Korea 411-360 +82 (31) 909-8275 +82 (31) 909-8276 Seung Hyun Kim / RA Team Manager
Dave Kim (davekim(@mtech-inc.net)
7707 Fannin St. Ste 200 V111, TX 77054
Official Correspondent Address Telephone
II. DEVICE
Trade/proprietary Name Model: Common or Usual Name Regulation Name Regulation Number Product Code Regulatory Class Review panel
Cybird LED Curing Light Cybird WPT Dental Curing Light Device Ultraviolet Activator for Polymerization 21 CFR 872.6070 EBZ Class II Dental
III. PREDICATE DEVICE
Primary Manufacturer Trade/proprietary Name Model: 510K Number Common or Usual Name Regulation Name Regulation Number Product Code Regulatory Class Review panel
DXM Co., Ltd Cybird LED Curing Light Cybird GOLD / Cybird XD K173876 Dental Curing Light Device Ultraviolet Activator for Polymerization 21 CFR 872.6070 EBZ Class II Dental
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Image /page/4/Picture/0 description: The image contains the logo for DXM. The logo consists of a green curved shape on the left, resembling a stylized checkmark or swoosh. To the right of the green shape, the letters "dxm" are written in a light blue sans-serif font. The overall design is simple and modern.
IV. DEVICE DESCRIPTION
Cybird is a LED curing light intended for polymerization of light-cured materials by dental professionals. This product is effective on various light-cured materials. Cybird's body is made from industrial-grade aluminum which is a durable material intended to ensure heat dissipation. The Cybird features multiple curing modes to ensure functionality.
V. INDICATIONS FOR USE:
The Cybird LED Curing Light is intended to polymerize resinous dental materials, restorative composite materials and orthodontic brackets, bonding and sealing materials that are photopolymerized in the 400-480 nm waveband of visible light.
| Descriptive
Information | Device: Cybird LED Curing Light
Model: Cybird WPT | Device: Cybird LED Curing Light
Model: Gold, XD, (K173876) | SE |
|------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| Intended Use | The Cybird LED Curing Light is intended to polymerize resinous dental
materials, restorative composite
materials, and orthodontic brackets,
bonding and sealing materials that are
photo-polymerized in the 400-480 nm
waveband of visible light. | The Cybird LED Curing Light is intended to polymerize resinous dental
materials, restorative composite
materials, and orthodontic brackets,
bonding and sealing materials that are
photo-polymerized in the 400-480 nm
waveband of visible light. | Same |
| Device
Design | Batteries: Li-ion with a working voltage
of: 3.7V, 2600mAh. Their safety
ratings: CE, RoHS, WEEE
Charger: Inductive Wireless Charger
Power On Button: Located on the
handle of the wand, front and back side | Batteries: Li-ion with a working voltage
of: 3.7V, 2600mAh. Their safety
ratings: CE, RoHS, WEEE
Charger: 4.2VDC Lithium Ion
battery charger
Power On Button: Located on the
handle of the wand, front and back side | SE1 |
| Operational
modes | High Power Mode: (5, 10, 15, 20 sec)
Plasma / Ortho Mode:
(3, 6, 9, sec, Ortho mode 55sec)
Device indicates illumination
time selection | High Power Mode: (5, 10, 15, 20 sec)
Plasma / Ortho Mode:
(2, 3, 4, sec. Ortho mode 55sec)
Device indicates illumination
time selection | SE2 |
| Light source | LED light, blue and violet
Wavelengths
8 light head diameter | LED light, blue and violet
Wavelengths
8 light head diameter | Same |
| Accessories | | | |
| Composition
of patient
contacting
Materials | Aluminum, anodized white
Barrier Sleeves. Light Shield. | Aluminum, anodized white
Barrier Sleeves. Light Shield. | Same |
| Light Guide | Fiber optic glass Black (11x8, 11x11) | Fiber optic glass Clear (11x8, 11x11) | SE3 |
| Light
Intensity | Plasma E. Mode / Ortho Mode:
11x8 Black Long(2034mW/Cm2)
11x11 Black Long(1294mW/Cm2)
High Power Mode:
11x8 Black Long(1104mW/Cm2)
11x11 Black Long (675mW/Cm2) | Plasma E. Mode / Ortho Mode:
11x8 Clear Shor(2581mW/Cm2)
11x11 Clear Short(1800mW/Cm2)
High Power Mode:
11x8 Clear Shor(1521mW/Cm2)
11x11 Clear Short(10430mW/Cm2)W | SE4 |
| Peak
wavelength | Dual peak: Approximately 405nm,
460nm | Dual peak: Approximately 405nm,
460nm (GOLD), 460nm (XD) | Same |
| Depth of
cure | Plasma mode (3, 6, 9 sec)
Spident Escom 100 (K110428):
- 11x8 Black: 3.08~4.47 mm
- 11x11Black: 2.24 ~ 2.88 mm
High Power mode (5,10, 15, 20 sec)
Spident Escom 100 (K110428): - 11x8 Black: 3.5~4.99mm
- 11x11Black: 3.05~3.95 mm | Plasma mode (2, 3, 4 sec)
Spident Escom 100 (K110428): - 11x8 Clear: 3.21~4.12 mm
- 11x11Clear: 2.89 ~ 3.45 mm
High Power mode (5, 10, 15, 20 sec)
Spident Escom 100 (K110428): - 11x8 Clear: 3.78~5.23 mm
- 11x11Clear: 3.41~4.45 mm | SE5 |
| Parameters
of
Disinfection | Chemical disinfection with approved
cleaning/sanitizing agents:
Cavicide products
Isopropyl alcohol (75%)
Ethyl alcohol based cleaners Lysol
disinfectant (alcohol-based only) | Chemical disinfection with approved
cleaning/sanitizing agents:
Cavicide products
Isopropyl alcohol (75%)
Ethyl alcohol based cleaners Lysol
disinfectant (alcohol-based only) | Same |
| Usability/Erg
onomics | 2 buttons – 1 power, 1 mode select | 2 buttons – 1 power, 1 mode select | Same |
| Power
source | 3.7V Li-ion Battery with inductive
wireless charging | 3.7V Li-ion Battery | Same |
VI. PREDICATE COMPARISON
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Image /page/5/Picture/0 description: The image contains the logo for DXM. The logo consists of a green curved shape on the left and the letters "dxm" in blue on the right. The green shape is abstract and appears to be a stylized representation of a wave or curve. The letters "dxm" are in lowercase and have a sans-serif font.
Discussion of the substantial equivalence decision;
Cybird WPT LED Curing Light has identical characteristics and intended uses as the 510(k) cleared light curing units, the Cybird LED curing Light (Model: Gold & XD, K173876), manufactured with identical materials and using the same energy source for the photopolymerization of dental materials, restorative composite materials and polymerization of bonding and sealing materials.
The intended use of the modified device has not changed.
The differences between the subject and the predicate device are listed below:
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Image /page/6/Picture/1 description: The image shows the DXM logo. The logo consists of a green curved shape on the left and the letters "dxm" in blue on the right. The curved shape is abstract and appears to be a stylized leaf or wave. The letters "dxm" are in lowercase and have a gradient effect, with the color fading from dark blue to light blue.
| SE1 | Device Design | Wireless Charger: The subject device is equipped with an Inductive Wireless Charger whereas the predicate device has 4.2VDC Lithium Ion battery charger. | The new wireless charger for the subject device delivers the same user convenience of a cordless charger for the predicate device. the spectral irradiance for both devices are identical. |
|---|---|---|---|
| SE2 | Operational modes | The exposure time in Plasma mode for Cybird WPT has been increased to 3, 6, 9 sec from 2, 3, 4 sec of the predicate device. | A longer light curing time for Plasma mode to achieve equivalent polymerization of RBC of black light guides in comparison with clear light guides, |
| SE3 | Light Guide | Fiber optic glass Black | Less light penetration through opaquer shade of a black light guide compared to a clear light guide. |
| SE4 | Light intensity with Light Guide. | The irradiance intensity of black light guides for Cybird WPT is about 20~30% lower than the Cybird Gold with clear light guides. | The irradiance intensity of Cybird WPT, the subject device, with a black light guide is about 20~30% lower than Cybird Gold with a clear light guide. |
| SE5 | Depth of cure | Many factors affect the degree of polymerization including the radiant intensity, exposure time and filler type | The depth of cure performances for the subject and predicate device are similar using Spident ESCOM – K110428. Other benefits of lower light intensity with longer exposure time during the resin polymerization are discussed. |
The battery charging method is an inductive wireless charger for the subject device and 4.2VDC Lithium Ion battery charger for the predicate device. The exposure time setting for the Plasma mode of the subject device with black guides is also increased to obtain to achieve equivalent polymerization of RBC in comparison with the predicate device with clear light guides.
Cybird WPT is equipped with black light guides, in spite of lower radiant intensity compared to Cybird Gold with a clear light guide, for the following reasons:
The use of black light guides can reduce high intensity light exposure to the eyes of patients and operators through filtering.
Moreover, relatively low radiant intensity over a longer exposure time may improve the uniform distribution and the degree of convergence of dental composites during the resin polymerization process.
These differences do not represent significant issues to clinical evaluation to fulfil the indication for use. In conclusion, the Cybird WPT LED Curing Light is substantially equivalent to the identified predicate device in terms of intended use, materials of construction, performance attributes and technological characteristics.
VII. SUMMARY OF NON-CLINICAL TESTS
7
Cybird LED Curing Light has been designed and tested according to the FDA guidance for Dental Curing Lights-Premarket Notification. Verification activities included curing hardness, depth of cure per ADA Specification No. 48.
Performance testing
Irradiance intensity test and spectral irradiance output were tested for both devices for comparison. The performance test results demonstrated that the Cybird WPT LED Curing light performed similar or better compared with the predicate device.
In addition, Cybird LED Curing Light complies with voluntary standards for biocompatibility (in vitro cytotoxicity, irritation and sensitization testing), electrical safety and EMC testing. The following data were provided to support the substantial equivalence determination:
Biocompatibility:
Cybird WPT LED Curing Light is manufactured with identical materials as the 510(k) cleared light curing units, the Cybird LED curing Light (Model: Gold & XD, K173876). All materials to be connected to the patient's skin are in conformity with AAMI / ANSI / ISO 10993-5:2009/(R) 2014, Biological Evaluation of Medical Devices-- Part 5: Tests for In Vitro Cytotoxicity (L929 Assay) and AAMI / ANSI / ISO 10993-10:2010, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
Electrical Safety and EMC essential performance testing was conducted in accordance with - AAMI ANSI ES 60601-1:2005/(R) 2012 and A1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD). - IEC 60601-1-2 Ed.3: 2007-03 Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
Software:
Software verification and validation testing as recommended in IEC62304:2006 Medical device software - Software life cycle processes and FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (May 11, 2005).
VIII. SUMMARY OF CLINICAL TESTS
Clinical testing was not required to demonstrate the substantial equivalence of Cybird WPT LED Curing Light to its predicate device.
IX. CONCLUSIONS
Validation and verification tests have been conducted to FDA guidance document Dental Curing Lights -Premarket Notification [510(k)]. Based on these comparison data, the sponsor believes that Cybird WPT LED Curing Light is substantially equivalent to Cybird Gold / XD LED Curing Light, the predicate device.