Premium Plus C01/C02 LED Curing Light

K153514 · Premium Plus International Limited · EBZ · Aug 22, 2016 · Dental

Device Facts

• Record ID: K153514
• Device Name: Premium Plus C01/C02 LED Curing Light
• Applicant: Premium Plus International Limited
• Product Code: EBZ · Dental
• Decision Date: Aug 22, 2016
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Handheld dental curing light; utilizes blue LED technology to polymerize light-cured dental materials. Device comprises handpiece, charging station, plug-in transformer, and protective light shield. C01 model uses fiber optic light guide; C02 model uses direct light source head. Operated by dental professionals in clinical settings. Three curing modes (Full, Ramp, Pulse) provide flexibility for various composites/sealants. Protective shield filters blue light for eye safety; barrier sleeves required between patients. Output is high-intensity blue light (440-480nm). Clinical benefit is efficient, reliable polymerization of dental resins.

Clinical Evidence

Bench testing only. Performance evaluated via electrical safety, electromagnetic compatibility, LED lamp testing, and depth of cure. Results confirm conformance to IEC 60601-1, IEC 60601-1-2, and ISO 10650-2 / ANSI/ADA Specification No. 48-2.

Technological Characteristics

Blue LED light source; 440-480nm wavelength (peak 460nm). Three operational modes: Full, Ramp, Pulse. Power: 3.7V 1100mAh Li-ion battery. Charging via AC 100-240V transformer. C01 features fiber optic light guide; C02 features direct light head. Standards: IEC 60601-1:2005, IEC 60601-1-2:2007, ISO 10650-2:2007. Handpiece dimensions: Ø2.7cm x 24cm; weight 160g.

Indications for Use

Indicated for trained dental professionals to polymerize dental light-cured materials (composites, bonding agents, sealants).

Regulatory Classification

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.

Predicate Devices

• Ledex WL-070 (K082408)
• Coltolux® LED Curing Light (K040551)

Reference Devices

• VALO® Cordless (K110582)

Submission Summary (Full Text)

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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.

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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 [phone] or [phone] 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 [phone] or [phone] 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: [phone], Facsimile: (852) 2761 3210, Email: [e-mail]

#### 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: [phone], Facsimile: (852) 2761 3210, Email: [e-mail]

### 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: [phone] Fax: [phone] Email: [e-mail]

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: [phone], Facsimile: (852) 2761 3210, Email: [e-mail]

#### (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<br>510(k) Number:K082408 | Premium Plus C01 LED<br>Curing Light |
|----------------------|---------------------------------------------------------------------------------------|---------------------------------------|
| Intended Use | Used by trained dental<br>professionals to polymerize dental<br>light cured materials | Same |
| Target Users | Professional Dentists and<br>Hygienists | Same |
| Light Source | LED light | Same |
| Operational<br>Modes | 3 modes: Full, Ramp, Pulse | Same |
| Power Source | 3.7V, 800mAh, Lithium-ion type | 3.7V, 1100 mAh, Lithium -<br>ion type |
| Power Supply | Input: AC100~240V, 50/60Hz<br>Output: DC 5V/2A | Input: AC 100-240V,<br>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: [phone], Facsimile: (852) 2761 3210, Email: [e-mail]

| | | Output: DC 5V/1A<br>(with charging station) |
|---------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------|
| The Range of<br>Wavelength | 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 in<br>autoclave | Same |
| Operating<br>Environmental<br>Factors | 10°C~40°C/30%~75%relative<br>humidity/500hPa~1060hPa<br>atmospheric pressure | Same |
| Handpiece Size | Ø2.6cm x 15.6cm | Ø2.7cm x 24cm |
| Weight | 120g | 160g |
| FDA- Recognized<br>Standards | EN60601-1 | IEC 60601-1:2005<br>IEC 60601-1-2:2007<br>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<br>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°C~40°C / relative humidity 80% at 25°C | 10°C~40°C / 30%~75% relative humidity / 500hPa~1060hPa atmospheric pressure |
| FDA- Recognized Standards | IEC60601-1-2 | IEC 60601-1<br>IEC 60601-1-2<br>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

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Flat 1001 Yuen Long Trading Centre, No. 33 Wang Yip Street West, Yuen Long, HONG KONG Phone: [phone], Facsimile: (852) 2761 3210, Email: [e-mail]

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.