(259 days)
No
The device description and performance studies focus on standard LED curing light technology and electrical/light safety, with no mention of AI or ML capabilities.
No.
The device cures dental composites by light. While it plays a role in dental procedures, its primary function is polymerization of materials, not the direct diagnosis, prevention, monitoring, treatment, or alleviation of disease or injury to a patient.
No
Explanation: The device is intended for curing dental composites by light, which is a treatment function, not a diagnostic one.
No
The device description clearly outlines physical hardware components including a handpiece, charging station, LED light source, fiber optic light guide, and transformer.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for the purpose of curing dental composites by light." This is a therapeutic/procedural use, not a diagnostic one.
- Device Description: The description focuses on the mechanism of action (polymerization of dental light cured materials) and the components of the device (LED light source, fiber optic guide, etc.). It does not mention any interaction with biological samples for diagnostic purposes.
- Classification: The device is classified as an "Ultraviolet Activator for Polymerization (21 CFR 872.6070)". This classification is for devices used in dental procedures, not for in vitro diagnostics.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
In vitro diagnostics are devices intended for use in vitro for the examination of specimens, including blood, tissues, and urine, from the human body to provide information for the diagnosis, monitoring, or treatment of disease. This dental curing light does not fit this definition.
N/A
Intended Use / Indications for Use
Premium Plus C01/C02 Dental Curing Light is intended for use by trained dental professionals for the purpose of curing dental composites by light.
Product codes
EBZ
Device Description
Premium Plus C01/C02 LED Curing Light is classified as an Ultraviolet Activator for Polymerization (21 CFR 872.6070) because it is used for polymerization of dental light cured materials by dental professionals. The device is based on blue LED (light emitting diode) technology. It has three curing modes. Using different modes gives dental professionals the flexibility to polymerize virtually almost all types of composites, boding agents and sealants available in the market.
Premium Plus C01/C02 LED Curing Light consists of a handpiece and a charging station, which is connected via a plug-in transformer to an AC outlet for charging. The handpiece contains high intensity dental blue LED light source and a fibre optic light guide(C01-1) that conduct light to the treatment area on the patients or direct light source head(C02-1). A protective light shield and transformer are accessories provided with Premium Plus C01/C02 LED Curing Light, which support the operation of the device. The protective light shield filters blue light to protect eyes of dental professionals and patients. An FDA cleared barrier sleeves must be used between each patient such as the Pac-Dent Barrier Sleeve.
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
Trained 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
The following tests were conducted to evaluate the functional performance and safety of Premium Plus C01/C02 LED Curing Light:
- Electrical Safety
- Electromagnetic Compatibility
- Light-emitting diode(LED) lamps
- Depth of Cure
The test results confirm that Premium Plus C01/C02 LED Curing Light conforms to the requirements in ISO 60601-1, ISO 60601-1-2 and ISO 10650-2 / ANSI/ADA Specification No. 48-2, LED Curing Lights, and is substantially equivalent for use as a dental curing light.
Key Metrics
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of a human face in profile, with three overlapping profiles suggesting a sense of community or interconnectedness. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the face, indicating the department's name and national affiliation.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 22, 2016
Premium Plus International Limited Jessica Mao QA Engineer Flat 1001 Yuen Long Trading Centre, 33 Wang Yip Street West, Yuen Long, N.T. Hong Kong CHINA
Re: K153514
Trade/Device Name: Premium Plus C01/C02 LED Curing Light Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet activator for polymerization Regulatory Class: Class II Product Code: EBZ Dated: July 7, 2016 Received: July 14, 2016
Dear Ms. Jessica Mao:
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.
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,
Michael J. Ryan -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
Flat 1001 Yuen Long Trading Centre, No. 33 Wang Yip Street West, Yuen Long, HONG KONG Phone: (852) 2761 3211, Facsimile: (852) 2761 3210, Email: jessicamao@premiumplushk.com
Section 4 Indications for Use Statement
510(k) Number (if known): K153514
Trade Name: Premium Plus C01/C02 LED Curing Light
Indications for Use: Premium Plus C01/C02 Dental Curing Light is intended for use by trained dental professionals for the purpose of curing dental composites by light.
AND/OR
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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Flat 1001 Yven Long Trading Centre, No. 33 Wang Yip Street West, Yven Long, HONG KONG Phone: (852) 2761 3211, Facsimile: (852) 2761 3210, Email: jessicamao@premiumplushk.com
Section 5 510(k) Summary [As Required by 21 CFR 807.92]
510(k) Number: K153514
Submitter: Premium Plus International Limited Flat 1001 Yuen Long Trading Centre, No. 33 Wang Yip Street West, Yuen Long, N.T. Hong Kong, China (Establishment registration number: 3006847937)
Contact Person: Jessica Mao QA Engineer Tel: 852-27613211 Fax: 852-27613210 Email: jessicamao@premiumplushk.com
Device Name: Activator, Ultraviolet, For Polymerization Trade Name: Premium Plus C01/C02 LED Curing Light Common Name: Dental Curing Light
Model Type: C01 & C02 (As they have same design requirements, performance specifications, technology, intended use and similar indications, they are summarized into one 510(k) submission, adherence to Section 4 of the guidance document for Bundling Multiple Device or Multiple Indications in a Single Submission )
Device Panel: Dental
Basis for Submission: New Device Regulation Name: Ultraviolet Activator for Polymerization
Device Classification: Class II
Regulation Number: 21 CFR 872.6070
Regulation Description: Ultraviolet activator for polymerization Product Code: EBZ
(A)Primary Predicate Device to Premium Plus C01 LED Curing Light:
Trade Name: Ledex WL-070 510(k) Number: K082408 Manufactured by: Dentmate Technology Company, Limited
(B) Primary Predicate Device to Premium Plus C02 LED Curing Light:
Trade Name: Coltolux® LED Curing Light 510(k) Number: K040551 Manufactured by: Coltene/Whaledent Incorporated
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Flat 1001 Yven Long Trading Centre, No. 33 Wang Yip Street West, Yven Long, HONG KONG Phone: (852) 2761 3211, Facsimile: (852) 2761 3210, Email: jessicamao@premiumplushk.com
(C) Reference Device for Performance Testing to Premium Plus C02 LED Curing Light:
Trade Name: VALO® Cordless 510(k) Number: K110582 Manufactured by: Ultradent Products, Inc.
Device Description:
Premium Plus C01/C02 LED Curing Light is classified as an Ultraviolet Activator for Polymerization (21 CFR 872.6070) because it is used for polymerization of dental light cured materials by dental professionals. The device is based on blue LED (light emitting diode) technology. It has three curing modes. Using different modes gives dental professionals the flexibility to polymerize virtually almost all types of composites, boding agents and sealants available in the market.
Premium Plus C01/C02 LED Curing Light consists of a handpiece and a charging station, which is connected via a plug-in transformer to an AC outlet for charging. The handpiece contains high intensity dental blue LED light source and a fibre optic light guide(C01-1) that conduct light to the treatment area on the patients or direct light source head(C02-1). A protective light shield and transformer are accessories provided with Premium Plus C01/C02 LED Curing Light, which support the operation of the device. The protective light shield filters blue light to protect eyes of dental professionals and patients. An FDA cleared barrier sleeves must be used between each patient such as the Pac-Dent Barrier Sleeve.
Indications for Use:
Premium Plus C01/C02 LED Curing Light is intended for use by trained dental professionals for the purpose of curing dental composites by light.
Technological Characteristics and Substantial Equivalence:
| Device | Ledex WL-070
510(k) Number:K082408 | Premium Plus C01 LED
Curing Light |
|----------------------|---------------------------------------------------------------------------------------|---------------------------------------|
| Intended Use | Used by trained dental
professionals to polymerize dental
light cured materials | Same |
| Target Users | Professional Dentists and
Hygienists | Same |
| Light Source | LED light | Same |
| Operational
Modes | 3 modes: Full, Ramp, Pulse | Same |
| Power Source | 3.7V, 800mAh, Lithium-ion type | 3.7V, 1100 mAh, Lithium -
ion type |
| Power Supply | Input: AC100~240V, 50/60Hz
Output: DC 5V/2A | Input: AC 100-240V,
50/60Hz |
Table 1: Comparison of the Proposed Device Premium Plus C01 LED Curing Light against the Predicate Device Ledex WL-070
An electronic copy of the submission is being provided which is an exact duplicate of the paper copy. Page 2 of 4 Section 5
5
Flat 1001 Yuen Long Trading Centre, No. 33 Wang Yip Street West, Yuen Long, HONG KONG Phone: (852) 2761 3211, Facsimile: (852) 2761 3210, Email: jessicamao@premiumplushk.com
| | | Output: DC 5V/1A
(with charging station) |
|---------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------|
| The Range of
Wavelength | 440nm480nm, peak:460nm | Same |40°C/30%
| Radiant Intensity | 1100 mw/cm²- 1200 mw/cm² | 750 mw/cm²- 1200 mw/cm² |
| Light Guide Rod | Ø8mm Optical fiber sterilization in
autoclave | Same |
| Operating
Environmental
Factors | 10°C75%relative1060hPa
humidity/500hPa
atmospheric pressure | Same |
| Handpiece Size | Ø2.6cm x 15.6cm | Ø2.7cm x 24cm |
| Weight | 120g | 160g |
| FDA- Recognized
Standards | EN60601-1 | IEC 60601-1:2005
IEC 60601-1-2:2007
ISO 10650-2:2007 |
Premium Plus C01 LED Curing Light and its predicate device Ledex WL-070 have identical intended use, operational principles and performance specifications. They also both transmit visible blue LED light at wavelength known to polymerize the dental resins. The devices are substantially equivalent in intended use, operation, wavelength range, light intensity, and light source.
Table 2: Comparison of the Proposed Device Premium Plus C02 LED Curing Light against the Predicate Device Coltolux® LED Curing Light
| Device | Coltolux® LED Curing Light
510(k) Number:K040551 | Premium Plus C02 LED Curing Light |
|---------------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|
| Intended Use | Used by trained dental professionals to polymerize dental light cured materials | Same |
| Light Source | LED Light | Same |
| Operational Modes | 1mode: Ready mode | 3 modes: Full, Ramp, Pulse |
| Power Source | Rechargeable battery | 3.7V, 1100 mAh, Lithium - ion type |
| Radiant Intensity | 300 mw/cm² or higher | 750 mw/cm²- 1200 mw/cm² |
| Accessories | Snap on light shields, barrier sleeves, light lenses, goggles, test block, adapter | Protective light shield, caps, head protective rings, adapter |
| Operating Environmental Factors | 10°C40°C / relative humidity 80% at 25°C | 10°C40°C / 30%75% relative humidity / 500hPa1060hPa atmospheric pressure |
| FDA- Recognized Standards | IEC60601-1-2 | IEC 60601-1
IEC 60601-1-2
ISO 10650-2:2007 |
An electronic copy of the submission is being provided which is an exact duplicate of the paper copy. Page 3 of 4 Section 5
6
Flat 1001 Yuen Long Trading Centre, No. 33 Wang Yip Street West, Yuen Long, HONG KONG Phone: (852) 2761 3211, Facsimile: (852) 2761 3210, Email: jessicamao@premiumplushk.com
Premium Plus C02 LED Curing Light and its primary predicate device Coltolux® LED Curing Light have the same intended use and light source. They both have the similar product appearance and power source, and require the similar operating environmental factors. Furthermore, they both are electrical safety and electromagnetic compatibility in accordance with IEC 60601-1-2.
Performance Test:
The following tests were conducted to evaluate the functional performance and safety of Premium Plus C01/C02 LED Curing Light:
- Electrical Safety
- Electromagnetic Compatibility
- Light-emitting diode(LED) lamps
- Depth of Cure ●
The test results confirm that Premium Plus C01/C02 LED Curing Light conforms to the requirements in ISO 60601-1, ISO 60601-1-2 and ISO 10650-2 / ANSI/ADA Specification No. 48-2, LED Curing Lights, and is substantially equivalent for use as a dental curing light.