(178 days)
No
The device description focuses on basic light curing technology with preset modes and times, and there is no mention of AI or ML in the text, including the dedicated "Mentions AI, DNN, or ML" section.
No
The device is used for light curing polymerization of dental materials, not for treating any specific disease or condition. Its function is to solidify materials, which is a restorative rather than a therapeutic action in the medical sense.
No
Explanation: The device is an LED Curing Light used for light curing polymerization of dental materials, which is a treatment function, not a diagnostic one.
No
The device description explicitly lists hardware components such as a high-power LED, main unit, curing light shield, charger, and charge station, and mentions the enclosure is made of ABS and Aluminum.
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 provide information about a person's health. These tests are performed outside of the body.
- Device Function: The LED Curing Light described is used to solidify dental materials directly in the patient's mouth. It is a therapeutic or procedural device, not a diagnostic one.
- Intended Use: The intended use is for "light curing polymerization of dental composites, luting materials, cements and other light cured materials," which is a treatment process.
- Device Description: The description focuses on the physical components and how it applies light to materials in situ.
The device is clearly used on the patient for a dental procedure, not for testing samples from the patient.
N/A
Intended Use / Indications for Use
For light curing polymerization of dental composites, luting materials, cements and other light cured materials.
Product codes
EBZ
Device Description
LED Curing Light is used to restore teeth on dental patient. The device can only be used by the dentist who is qualified and well trained. This product is used on dental patient in the place of hospital or professional medical site.
LED Curing Light adopts the principle of ray radiation to solidify the light sensitive resin by shooting at it in a short time. It is composed of high-power LED, main unit, curing light shield, charger and charge station. The main unit contains the ON/OFF button, display screen, mode button and time button.
LED Curing Light provides TURBO mode and NORMAL mode with different preset exposure time. The high-power LED can produce visible blue light in the 430nm to 490nm waveband of spectrum with a power density of 1000m W/cm² to 1800m W/cm². Using different modes gives dental professionals the flexibility to polymerize virtually almost all types of composites, boding agents and sealants available in the market.
The enclosure of main unit was composed of ABS material and Aluminum, and the light guide base (patient contact part) was made from ABS material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Teeth (dental patient)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Used by the dentist who is qualified and well trained. Used on dental patient in the place of hospital or professional medical site.
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 light output Performance of subject device was evaluated for below testing item:
- ANSI ADA 48: 2004 Visible light curing unit (FDA recognition number 4-139)
- IEC 80601-2-60 Medical Electrical Equipment - Part 2-60: Particular Requirements For The Basic Safety And Essential Performance Of Dental Equipment, Edition 1.0 2012-02 (FDA recognition number 4-229)
Electrical safety and EMC testing were conducted on the subject device, and was found to comply with ANSI/AAMI 60601-1 and IEC 60601-1-2.
The biocompatibility of subject device was evaluated for below items:
- ISO 10993-5:2009, biological evaluation of medical devices -- part 5: tests for in vitro cytotoxicity (FDA recognition number 2-245 )
- ISO 10993-10 Third Edition 2010-08-01, biological evaluation of medical devices - part 10: tests for irritation and skin sensitization (FDA recognition number 2-174)
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was determined to be of "moderate" level of concern.
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that 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.
February 13, 2020
Foshan CICADA Dental Instrument Co., Ltd. % Jet Li Regulation Manager KEDA Biological Technology Co., Ltd. 6F, No.1 TianTai road, Science City, LuoGang District Guangzhou, CHINA
Re: K192233
Trade/Device Name: LED Curing Light Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: Class II Product Code: EBZ Dated: December 7, 2019 Received: December 16, 2019
Dear Jet Li:
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 mediation-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 Srivinas '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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K192233
Device Name LED Curing Light, Model CV-215
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) |
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3
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 872.6070.
1. Submitter Information
Sponsor: Foshan CICADA Dental Instrument Co, Ltd .
Address: B5-2F, Guangdong New Light Source Industrial Base, Shihan Town, Nanhai
District, Foshan, Guangdong, China
Contact Person: Juan Liu
Phone: 86-757-85775667
E-mail: yc2922@126.com
Application Correspondent: Jet Li Company: Guangzhou KEDA Biological Technology Co., Ltd E-mail: med-jl@foxmail.com Phone: 86-18588874857 Address: 6F, No.1 TianTai road, Science City, LuoGang District, GuangZhou City, China
2. Subject Device Information
| Type of 510(k) submission: | Traditional |
|---|---|
| Common Name: | Dental Curing Light Device |
| Trade Name: | LED Curing Light, Model CV-215 |
| Classification Name: | Ultraviolet activator for polymerization |
| Review Panel: | Dental |
| Product Code: | EBZ |
| Regulation Number: | 21 CFR 872.6070 |
| Regulation Class: | 2 |
4
3. Predicate Device Information
| Sponsor: | DENTALL Co., Ltd. |
|---|---|
| Common Name: | Ultraviolet Activator for Polymerization |
| Trade Name: | Delight, Delight ortho, B&Lite S |
| 510(k) number: | K170529 |
| Review Panel: | Dental |
| Product Code: | EBZ |
| Regulation Number: | 21 CFR 870.1130 |
| Regulation Class: | 2 |
Device Description 4.
LED Curing Light is used to restore teeth on dental patient. The device can only be used by the dentist who is qualified and well trained. This product is used on dental patient in the place of hospital or professional medical site.
LED Curing Light adopts the principle of ray radiation to solidify the light sensitive resin by shooting at it in a short time. It is composed of high-power LED, main unit, curing light shield, charger and charge station. The main unit contains the ON/OFF button, display screen, mode button and time button.
LED Curing Light provides TURBO mode and NORMAL mode with different preset exposure time. The high-power LED can produce visible blue light in the 430nm to 490nm waveband of spectrum with a power density of 1000m W/cm² to 1800m W/cm². Using different modes gives dental professionals the flexibility to polymerize virtually almost all types of composites, boding agents and sealants available in the market.
The enclosure of main unit was composed of ABS material and Aluminum, and the light guide base (patient contact part) was made from ABS material.
5. IntendedUse/ Indication for Use
For light curing polymerization of dental composites, luting materials, cements and other light cured materials.
Test Summary 6.
5
K192233
LED Curing Light has been evaluated the safety and performance by lab bench testing according to the following standards:
A Performance Testing
The light output Performance of subject device was evaluated for below testing item:
- ANSI ADA 48: 2004 Visible light curing unit (FDA recognition number 4-139) 区
风 IEC 80601-2-60 Medical Electrical Equipment - Part 2-60: Particular Requirements For The Basic Safety And Essential Performance Of Dental Equipment, Edition 1.0 2012-02 (FDA recognition number 4-229)
> Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the subject device, and was found to comply with ANSI/AAMI 60601-1 and IEC 60601-1-2.
Detail standard lists is as below items:
- -ANSI/AAMI 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 2005+A1:2012 (FDA recognition number 19-4)
- -IEC 60601-1-2, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests, 2014 (FDA recognition number 19-8)
A Biocompatibility Testing
The biocompatibility of subject device was evaluated for below items:
- ISO 10993-5:2009, biological evaluation of medical devices -- part 5: tests for in vitro cytotoxicity (FDA recognition number 2-245 )
- ISO 10993-10 Third Edition 2010-08-01, biological evaluation of medical devices - । part 10: tests for irritation and skin sensitization (FDA recognition number 2-174)
A Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was determined to be of "moderate" level of concern.
7. Clinical Testing
Clinical data were not required in this submission to support a finding of substantial equivalence.
6
8. Comparison to Predicate Device
Compare with predicate device, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between subject device and predicate device do not raise any new questions of safety or effectiveness.
| Elements of
| Comparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Manufacturer | Foshan CICADA Dental Instrument | ||
| Co, Ltd | DENTALL Co., Ltd. (K170529) | -- | |
| Product Name | LED Curing Light, Model: CV-215 | Delight, Delight ortho, B&Lite S | SE Note |
| 1 | |||
| Indications for Use | |||
| 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. | SE | ||
| Device Design | |||
| Power source | Rechargeable Lithium battery with | ||
| IEC 62133 Approval | Li-ion battery with IEC 62133 | ||
| Approval | SE | ||
| Light source | 5W high-power blue light LED | blue light LED | SE |
| Note 2 | |||
| Operational mode | TURBO mode: exposure time (1,3 | ||
| seconds) | |||
| NORMAL mode: exposure time | |||
| (5,10,15,25,30 seconds) | Standard: 5,10,15,20s duration | ||
| High: 3,6,9,12 s duration | |||
| Soft start: 5, 10, 15s duration | SE | ||
| Note 2 | |||
| Usability | The Display screen and function | ||
| buttons (ON/OFF, Mode, Time) | |||
| located on the main unit. | A plastic rotation switch provides | ||
| various modes selection. | |||
| An ON/OFF button activates and | |||
| executes the selected mode. | SE | ||
| Note 2 | |||
| Elementsof | |||
| Comparison | Subject Device | Predicate Device | Verdict |
| Accessories | Curing light shield, Charger, | ||
| Adapter, and the main unit | Cordless handpiece, Battery packs, | ||
| Curing light shield | SE | ||
| Technical Specifications | |||
| Light intensity | $1000mW/cm^2-1800mW/cm^2 \pm 10%$ | $800mW/cm^2-2700mW/cm^2$ | SE |
| Note 3 | |||
| Light wavelength | 430nm-490nm | 430~490nm range | SE |
| Peak wavelength | 455 nm | 460nm | SE |
| Material information | |||
| Patient Contact | |||
| material: Light | |||
| guide base | ABS plastic | ||
| (Comply with ISO 10993-5; ISO | |||
| 10993-10) | ABS plastic | ||
| (Comply with ISO 10993-5; ISO | |||
| 10993-10) | SE | ||
| FDA-Recognized Standards | |||
| Electrical safety, | |||
| EMC, Biological | |||
| Evaluation | ANSI/AAMI 60601-1:2005+A1 | ||
| 2012 | |||
| IEC 60601-1-2:2014 | |||
| IEC 80601-2-60:2012 | |||
| ADA No 48:2004 | |||
| ISO 10993-5:2009 | |||
| ISO 10993-10:2010 | IEC 60601-1 | ||
| IEC 60601-1-2 | |||
| ADA 48 / ISO 10650 | |||
| ISO 10993-5:2009 | |||
| ISO 10993-10:2010 | SE |
7
K192233
Note 1
Although there is little difference for their model name, but its common names are the same. This difference does not affect the safety and effectiveness.
Note 2
Although the device design and operational mode between the predicate device and subject device are minor different, they are both complied with IEC60601-1 and its performance comply with IEC80601-2-60, AND ADA 48. The differences do not affect the safety and effectiveness.
8
K192233
Note 3
Although the light output intensity specification is mirror different, but the light intensity range of subject device is within the effective power range of predicate device, and the safety and performance of the subject device is verified via tests, and it is complied with IEC 60601-1 and IEC 80601-2-60. The differences do not affect the safety and effectiveness.
9. Conclusion
The subject device LED Curing Light has all features of the predicate device for intended use. Thus, the subject device is substantially equivalent to the predicate device.
10. Summary Prepared Date
09 Jan 2020