(34 days)
Not Found
No
The summary describes a standard LED curing light with different power modes and exposure times, and there is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device's intended use is to polymerize dental materials, not to diagnose, treat, or prevent disease, which are core functions of therapeutic devices.
No
The device is described as an LED curing light intended to polymerize resinous dental materials. Its function is to harden materials using light, not to diagnose medical conditions or analyze data to provide diagnostic information.
No
The device description explicitly states the device has a body made from industrial-grade aluminum and features LED lights, indicating it is a hardware device.
Based on the provided text, the Cybird LED Curing Light is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to polymerize resinous dental materials, restorative composite materials, and orthodontic materials. This is a physical process performed directly on the patient's teeth or materials applied to the teeth.
- Device Description: The device description focuses on the light source, power density, and curing modes, all related to the physical act of curing materials.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The Cybird LED Curing Light does not interact with or analyze human specimens in this way.
The device is clearly intended for use by dental professionals to perform a physical procedure in the mouth.
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 rapid polymerization of light-cured materials by dental professionals. This product effectively reduces polymerization time on various lightcured materials and provides excellent treatment results every time. Cybird's body is made from industrial-grade aluminum which ensures its durability and excellent heat dissipation. The Cybird features multiple curing modes for maximum functionality.
The Cybird curing light produces visible blue light in the 405 nm (Gold) & 465 nm (Gold / XD) peak waveband of spectrum with a power density of 1,500mW/cm² (High Power Mode), 2,500 mW/cm2 (Ortho Mode, Gold), 2,700mW/cm2 (Ortho Mode, XD). These power densities are sufficient for the product intended uses.
405 nm (Gold) & 465 nm (Gold / XD) peak waveband of visible light cured (VLC) orthodontic brackets and orthodontic bonding and sealing materials.
Exposure times can be set for 1.5, 2, 2,5, 3 seconds for XD in Ortho Mode; 2, 3, 4 seconds for Gold in Ortho Mode; and 5,10,15, or 20 seconds in High Power Mode.
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
dental professionals
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 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, maximum light intensity measurements at 2 mm for all power modes, and spectral irradiation plots of all power modes.
The 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:
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. The difference of material used between subject and predicate device does not affect safety and effectiveness.
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 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)
Not Found
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 contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 24, 2018
DXM Co., Ltd % Dave Kim President Mtech Group 8310 Buffalo Speedway Houston, Texas 77025
Re: K173876
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: December 27, 2017 Received: January 3, 2018
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mary S. Runner -S
for Tina Kiang, Ph.D. 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
Indications for Use
510(k) Number (if known) K173876
Device Name Cybird LED Curing Light Model: Cybird GOLD, Cybir XD
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 logo for DXM. The logo consists of a green curved shape on the left, followed by the letters "dxm" in a light blue color. The curved shape has a gray line underneath it.
510(k) Summary
K173876
This summary of Special 510(k) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
| Date 510k summary prepared: | December 29, 2017 | ||
|---|---|---|---|
| I. | SUBMITTER | ||
| Submitter's Name | DXM Co., Ltd. | ||
| Submitter's Address | Baekseok-dong, Ilsan technotown 1003, 138, | ||
| Ilsan-ro, Ilsandong-gu Goyang-si, | |||
| Gyeonggi-do, Republic of Korea 411-360 | |||
| Submitter's Telephone | +82 (31) 909-8275 | ||
| Submitter's Fax | +82 (31) 909-8276 | ||
| Contact person | Seung Hyun Kim / RA Team Manager | ||
| Official Correspondent | Dave Kim (davekim@mtech-inc.net) | ||
| Address | 8310 Buffalo Speedway, Houston, TX 77025 | ||
| Telephone/Fax | +713-467-2607 / +713-583-8988 | ||
| II. | DEVICE | ||
| Submission Type: | Special 510K | ||
| Trade/proprietary Name | Cybird LED Curing Light | ||
| Model: | Cybird GOLD / Cybird XD | ||
| Common or Usual Name | Dental Curing Light Device | ||
| Regulation Name | Ultraviolet Activator for Polymerization | ||
| Regulation Number | 21 CFR 872.6070 (Product Code: EBZ) | ||
| Regulatory Class | Class II | ||
| Review panel | Dental | ||
| Prescription Use only | |||
| III. | PREDICATE DEVICE | ||
| Primary Manufacturer | DXM Co., Ltd | ||
| Trade/proprietary Name | D1 LED Curing Light or SPEC3 or LED 3000 | ||
| Common or Usual Name | Dental Curing Light Device | ||
| Regulation Name | Ultraviolet Activator for Polymerization | ||
| Regulation Number | 21 CFR 872.6070 (Product Code: EBZ) | ||
| Regulatory Class | Class II | ||
| Review panel | Dental | ||
| Prescription Use only | |||
| This predicate has not been subject to a design-related recall. | |||
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Image /page/4/Picture/0 description: The image shows the DXC Technology 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 a stylized representation of a leaf or a wave. The letters "dxm" are in a sans-serif font and are slightly italicized.
IV. DEVICE DESCRIPTION
Cybird is a LED curing light intended for rapid polymerization of light-cured materials by dental professionals. This product effectively reduces polymerization time on various lightcured materials and provides excellent treatment results every time. Cybird's body is made from industrial-grade aluminum which ensures its durability and excellent heat dissipation. The Cybird features multiple curing modes for maximum functionality.
The Cybird curing light produces visible blue light in the 405 nm (Gold) & 465 nm (Gold / XD) peak waveband of spectrum with a power density of 1,500mW/cm² (High Power Mode), 2,500 mW/cm2 (Ortho Mode, Gold), 2,700mW/cm2 (Ortho Mode, XD). These power densities are sufficient for the product intended uses.
405 nm (Gold) & 465 nm (Gold / XD) peak waveband of visible light cured (VLC) orthodontic brackets and orthodontic bonding and sealing materials.
Exposure times can be set for 1.5, 2, 2,5, 3 seconds for XD in Ortho Mode; 2, 3, 4 seconds for Gold in Ortho Mode; and 5,10,15, or 20 seconds in High Power Mode.
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
dental curing light | D1 LED Curing Light or SPEC3 or
LED 3000 (K121093) |
|-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 D1 LED Curing Light & accessories
is intended to polymerize resinous
dental materials, restorative composite
materials, orthodontic brackets
bonding and sealing materials that are
photo-polymerized in the 430-490nm
waveband of visible light. |
| Device
Design
(operational
modes, light
source,
power
source, and
accessories) | 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 | Batteries: Lithium-polymer with a
working voltage of: 3.7V, 1200mAh.
Their safety ratings: CE, RoHS, WEEE
Charger: 4.2VDC Lithium Ion
battery charger
AC Power Supply:
Input: 100V-240V AC/50/60 Hz
Output: +6V DC 2.2A (Bridge power
corp - model #
JMW118KA0602N01) |
| | | Power On Button: Located on the |
| | | handle of the wand, back side only |
| Operational
modes | High Power Mode: 1500mW/cm2
(5, 10, 15, 20 sec)
Plasma / Ortho Mode:
2,500 ~2,700mW/cm2 (2, 3, 4, sec
Ortho mode 55sec)
Device indicates illumination
time selection
Device indicates time and time
selection | High Power Mode: 1500mW/cm2
(5,10,20,40 sec)
Plasma / Ortho Mode:
3,000mW/cm2 (1,2,3 sec Ortho mode
55 sec)
Device indicates illumination
time selection
Device indicates time and time
selection |
| Light source | LED light, blue and violet | LED light, blue and violet |
| | Light guide size (diameter): 8 mm
LED Array Manufacturer: ITSWELL
Model: IWC-B10C6-VB-JS0303
Rating: Max IF = 1050mA | Light guide size (diameter): 10mm
LED Array Manufacturer: Led Engin
Model: LZ4-00B210
Rating Max IF = 1500mA |
| Accessories | | |
| Composition | Aluminum, anodized white | Aluminum, anodized various colors |
| of patient
contacting
Materials | Barrier Sleeves. Light Shield. | |
| Light
intensity, | Plasma E. Mode / Ortho Mode:
2,500mW/cm2 (2, 3, 4, sec Ortho mode
55sec)
High Power Mode: 1,500 mW/cm2 (5,
10, 15, 20 sec) | Plasma / Ortho Mode:
3,000mW/cm2 (1,2,3 sec)
High Power Mode: 1500mW/cm2
(5,10,20,40 sec) |
| Peak
wavelength | Dual peak: 405nm, 465nm (GOLD)
465nm (XD) | 465nm |
| Depth
of
cure | Plasma mode (2 sec)
- Handae Chemical, Hanfil: 2.270mm
- Spident Escom 100 (K110428): 2.100mm
- Dentkist Charmfil Plus: 2.380mm
- Mediclus Anycom: 2.035mm
High Power mode (10 sec) - Handae Chemical, Hanfil: 3.795mm
- Spident Escom 100 (K110428): 3.490mm
- Dentkist Charmfil Plus: 3.765mm
- Mediclus Anycom: 2.370mm | 2.5mm |
| Parameters | Chemical disinfection with approved | Chemical disinfection with approved |
| of
Disinfection | cleaning/sanitizing agents:
Cavicide products | cleaning/sanitizing agents:
Cavicide products |
| | Isopropyl alcohol (75%) | Isopropyl alcohol (75%) |
| | Ethyl alcohol based cleaners Lysol
disinfectant (alcohol-based only) | Ethyl alcohol based cleaners Lysol
disinfectant (alcohol-based only) |
| Usability/Erg
onomics | 2 buttons – 1 power, 1 mode select | 2 buttons – 1 power, 1 mode select |
PREDICATE COMPARISON VI.
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Image /page/5/Picture/0 description: The image shows the logo for DXM. The logo consists of a green curved shape on the left and the letters "dxm" in light blue on the right. The curved shape is reminiscent of a check mark or a stylized leaf. The letters "dxm" are in lowercase and have a rounded, sans-serif font.
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Image /page/6/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 rounded font.
Discussion of the substantial equivalence decision;
The Cybird LED Curing Light has similar characteristics and intended uses as the 510(k) cleared light curing units, the D1 LED Curing Light or SPEC3 or LED 3000 (K121093), 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.
These devices are well established and determined to be safe and effective.
The differences between the subject and the predicate device are the LED light source, light guard diameter, the power mode, and the exposure time.
Luminous/Radiant Flux for Cybird LED Curing Light is lower compared to the predicate device. However, light is distributed evenly on the exposure surface whereas the predicate device's light intensity is higher on the center of the surface.
These differences thus raise no new questions of safety and effectiveness and do not represent significant issues to clinical evaluation to fulfil the indication for use. In conclusion, the Cybird LED Curing Light is substantially equivalent to the identified predicate device in regard to intended use, materials of construction, performance attributes and technological characteristics.
Furthermore, the intended use of the modified device has not changed as a result of the modifications.
VII. SUMMARY OF NON-CLINICAL TESTS
The 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, maximum light intensity measurements at 2 mm for all power modes, and spectral irradiation plots of all power modes.
The 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:
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. The difference of material used between subject and predicate device does not affect safety and effectiveness.
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Image /page/7/Picture/0 description: The image shows the DXC Technology logo. The logo consists of a green curved arrow pointing to the right, followed by the letters "dxm" in blue. The arrow is a stylized representation of a forward-moving direction, and the letters are in a sans-serif font.
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 the Cybird LED Curing Light to its predicate device.
IX. CONCLUSIONS
Based on the information above, the sponsor believes that Cybird LED Curing Light is substantially equivalent to the predicate device. The differences between the Cybird LED Curing Light and its predicate do not raise different questions of safety and effectiveness.