(259 days)
Premium Plus C01/C02 Dental Curing Light is intended for use by trained dental professionals for the purpose of curing dental composites by light.
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.
This document is a 510(k) premarket notification for a dental curing light, the Premium Plus C01/C02 LED Curing Light. It aims to establish substantial equivalence to existing predicate devices. The information provided focuses on technical specifications and safety standards rather than clinical performance or AI algorithm validation.
Therefore, many of the requested details, such as acceptance criteria based on clinical metrics (e.g., sensitivity, specificity), sample size for test sets, ground truth establishment by experts, adjudication methods, or effects of AI assistance, are not applicable or not available in this document.
The document primarily relies on comparisons of technical characteristics and adherence to recognized safety and performance standards to demonstrate substantial equivalence.
Here's a breakdown of the available and unavailable information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in terms of clinical performance metrics (like sensitivity, specificity, or human improvement with AI). Instead, it relies on demonstrating that the device meets recognized industry standards and performs comparably to predicate devices based on technical specifications and safety tests.
Therefore, instead of a clinical performance table, below are the relevant technical and safety performance criteria that were met:
| Acceptance Criterion (Standard/Predicate Feature) | Reported Device Performance (Premium Plus C01/C02) |
|---|---|
| Electrical Safety | Conforms to IEC 60601-1 |
| Electromagnetic Compatibility | Conforms to IEC 60601-1-2 |
| LED Lamps Performance | Conforms to ISO 10650-2 / ANSI/ADA Specification No. 48-2 (LED Curing Lights) |
| Depth of Cure | "Depth of Cure" test conducted, results confirm conformance to requirements in ISO 10650-2 / ANSI/ADA Specification No. 48-2 (implied) |
| Intended Use (vs. Predicate) | Same as predicate devices (Ledex WL-070, Coltolux® LED Curing Light) |
| Light Source (vs. Predicate) | Same (LED light) |
| Wavelength Range (C01 vs. Ledex WL-070) | Same (440nm~480nm, peak: 460nm) |
| Radiant Intensity (C01 vs. Ledex WL-070) | Within comparable range (750 mw/cm²- 1200 mw/cm² vs. 1100 mw/cm²- 1200 mw/cm²) |
| Radiant Intensity (C02 vs. Coltolux®) | Meets or exceeds (750 mw/cm²- 1200 mw/cm² vs. 300 mw/cm² or higher) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified for any clinical or performance comparison study. The document refers to "Performance Tests" for Electrical Safety, EMI, LED lamps, and Depth of Cure, but the number of units or materials tested is not mentioned.
- Data Provenance: Not applicable as there's no patient data or clinical imagery discussed. All testing appears to be laboratory-based and related to device specifications and safety.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. The "ground truth" here is adherence to technical standards and specifications, not clinical diagnoses or interpretations. These standards are established by regulatory bodies and consensus organizations, not individual experts in a test set.
4. Adjudication Method for the Test Set
Not applicable. There's no interpretive task that would require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a dental curing light, not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device does not involve an algorithm for standalone performance.
7. The Type of Ground Truth Used
The "ground truth" for this device's approval is based on:
- Compliance with recognized international and national standards: IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (Electromagnetic Compatibility), ISO 10650-2 / ANSI/ADA Specification No. 48-2 (LED Curing Lights).
- Demonstrated technical equivalence in key specifications (intended use, light source, wavelength, radiant intensity, operational modes, power, environmental factors, safety standards) to already approved predicate devices.
8. The Sample Size for the Training Set
Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this device.
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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.
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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
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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-070510(k) Number:K082408 | Premium Plus C01 LEDCuring Light |
|---|---|---|
| Intended Use | Used by trained dentalprofessionals to polymerize dentallight cured materials | Same |
| Target Users | Professional Dentists andHygienists | Same |
| Light Source | LED light | Same |
| OperationalModes | 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, 50/60HzOutput: 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
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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 ofWavelength | 440nm~480nm, peak:460nm | Same |
| Radiant Intensity | 1100 mw/cm²- 1200 mw/cm² | 750 mw/cm²- 1200 mw/cm² |
| Light Guide Rod | Ø8mm Optical fiber sterilization inautoclave | Same |
| OperatingEnvironmentalFactors | 10°C~40°C/30% | Same |
| Handpiece Size | Ø2.6cm x 15.6cm | Ø2.7cm x 24cm |
| Weight | 120g | 160g |
| FDA- RecognizedStandards | EN60601-1 | IEC 60601-1:2005IEC 60601-1-2:2007ISO 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 Light510(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°C~40°C / relative humidity 80% at 25°C | 10°C~40°C / 30% |
| FDA- Recognized Standards | IEC60601-1-2 | IEC 60601-1IEC 60601-1-2ISO 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
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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.
§ 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.