【Case Study】LED Dental Curing Light Registration in China

1. Introduction

Product Name: LED Curing Light, Dental Curing Light

Product Composition:

1. Network power supply: main unit, power adapter, light guiding component, shading device, etc.

2. Internal power supply: main unit, power adapter, battery, light guiding component, charging stand, etc.

Working Principle: The light-emitting diode is used as a light source to emit a light source of a certain wavelength effective for the dental restoration material, and the light-conducting component collects light and is led out, so that the dental restoration material is rapidly solidified under the action of the radiation energy.

Typical Structure:

 

2. Classification

Classification Code: 17-03-06 Class II curing equipment

Product Description: It usually consists of a light source handle and a power supply. By emitting light of a specific wavelength and utilizing the principle of photopolymerization, the photocurable material is rapidly and efficiently polymerized and cured in a short time. The light source has two types: quartz tungsten halogen lamp and LED lamp.

Expected Usage: Used to cure photocurable materials.

3. Registration Unit

Classified by light source:

1. Light curing device with quartz tungsten halogen lamp as light source

2. Light curing device with light emitting diode (LED) lamp as light source

Classified by power supply:

1.1. Stand-alone device, a light curing unit powered by a power supply network (including the type that can be used with either a network power supply or an internal battery)

1.2. Accessories, the dental treatment machine is only powered, clinically adjusted by the curing machine itself to the treatment mode and the output of light energy

1.3. Accessories, which is a built-in module of the dental treatment machine. Powered by the dental unit and adjusted by the control panel of the dental unit to the treatment mode and light energy output of the curing unit

2. Stand-alone device, light curing unit powered by internal battery (e.g. rechargeable battery)

Note:Different light source and power supply should be divided to different registration units, but the LED curing light with power supply 1.1 and 1.2 (having charging base)

4. Technical Requirements

Performance index (for LED curing device with internal battery):

1. General requirements: Clause 5.1 of YY 0055.2-2009

2. Requirements of Radiation:

Light source

Light emitting diode (LED) lamp

Power supply

Stand-alone device, powered by internal battery

Working Mode

Wavelength range (unit: nm)

Radiation value (unit: mW/cm2)

Mode 1

Full wave band

Required by enterprise

190385

Not more than 100

400515

Required by enterprise

515

Not more than 100

3. Appearance: The surface of the whole product should be smooth and clean, and there should be no defects such as corrosion spots, dirt and scratches; plastic and rubber products must not have defects such as foaming, cracking, mildew, sharp edges, burrs and deformation.

4. Light guiding element: including optical effective area and tolerance.

5. Photobiosafety: the requirements in GB/T 20145-2006.

6. Safety requirements: the requirements in GB 9706.1-2007 medical electrical equipment Part 1: Safety general requirements.

7. Electromagnetic compatibility requirements: the requirements in YY 0505-2012.

8. Environmental test requirements: the requirements of the climatic environment test group II and the mechanical environment group II in GB/T 14710-2009.

Table 1 Relevant Product Standards

Standard Number

Standard Name

GB 9706.1-2007

Medical electrical equipment –

Part 1: General requirements for safety

YY 0505-2012

Medical electrical equipment - Part 1-2: Safety general requirements parallel standard: Electromagnetic compatibility

GB/T 14710-2009

Medical electrical environment requirements and test methods

YY/T 0316-2008

Medical device risk management for medical devices

GB/T 16886.1-2011

Biological evaluation of medical devices –

Part 1: Evaluation and testing in the process of risk management

YY/T 0268-2008

Dentistry Oral Medical Device Biology Evaluation

Unit 1: Evaluation and Trial

YY 0055.1-2009

Dental curing light - Part 1: Quartz tungsten halogen lamps

YY 0055.2-2009

Dental curing cameras - Part 2: Light-emitting diode (LED) lamps

GB 9706.15-2008

Medical electrical equipment - Part 1-1: General safety requirements parallel standard: Medical electrical system safety requirements

YY 0709-2009

Medical electrical equipment-Part 1-8: General requirements for safety. Parallel standard: General requirements, testing and guidance for alarm systems in medical electrical equipment and medical electrical systems

GB 4943.1-2011

Information technology equipment - Safety –

Part 1: General requirements

YY(/T): Industry standard (Recommendation)

GB(/T): National standard (Recommendation)

5. Clinical Trials

Animal Test or Small Sample Test: not required

Clinical Trials: not required

In Medical Device Catalog Exempted from Clinical Trials

The blue light is irradiated by the repairing material to cure the material, and the light curing machine is divided into a quartz tungsten halogen lamp as a light source and an LED light curing device which is a light source (LED) lamp as a light source. Product performance indicators use the applicable parts of the following reference standards, such as: YY 0055 light curing machine series standards.

6. Registration Cost and Duration

1) Product Testing

Test items

Testing duration(90 working days total)

Testing fee(USD)

Safety Performance

90

6,000

EMC

90

3,700

Biocompatibility

35

3,000

Notes:

1. The price of EMC is only the price of one operating mode. If there are multiple operating modes, it needs to be re-priced;

2. Biocompatibility is only the price of a single material, such as a variety of materials and human contact, need to accumulate;

3. Biocompatibility is only the way the material and the human body are in contact with the oral mucosa, short-term contact within 24h

2) Technology Approval

60 working days

Another 60 working days if the 1-year supplement is required

3) Administrative Approval

20 working days

If you would like to get the detailed registration proposal, please contact us via md@cirs-group.com.

 

Contact Us
CIRS China

Ms. Shuo Wang (Head office)
Tel: +86-571 8720 6559 | Fax: +86-571 87206533
Email: md@cirs-group.com
Mr. Edwin Wen (Beijing office)
Tel: +86-10 63984062 | Fax: +86-10 63984032
Email: md@cirs-group.com

CIRS Europe

Bryan Zhou
Tel:  +353 (1)477 3710

Email: md@cirs-group.com

CIRS Korea
Mr. Junho Lee 
Tel: +82 2 6347 8801 
Email: md@cirs-group.com