LED.L, LED.M, LED.G, LED.B

K080025 · Guilin Woodpecker Medical Instrument Co., Ltd. · EBZ · Mar 19, 2008 · Dental

Device Facts

• Record ID: K080025
• Device Name: LED.L, LED.M, LED.G, LED.B
• Applicant: Guilin Woodpecker Medical Instrument Co., Ltd.
• Product Code: EBZ · Dental
• Decision Date: Mar 19, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

WOODPECKER Curing light LED.L., LED.M, LED.G LED.B with blue LED is a device which generates high intensity light for polymerization of light-curing materials used for dental curing purpose. Unlike Halogen light generating full light spectrum, it only emits light with wavelength primarily in the range of 440 to 490nrn. This is the applicable range for dental Curing of camphor quinine (CPQ) containing products.

Device Story

Dental curing light models (LED.L, LED.M, LED.G, LED.B) utilize blue LED technology to emit high-intensity light in the 440-490nm wavelength range. Device designed for polymerization of light-curing dental materials containing camphor quinine (CPQ). Operated by dental professionals in clinical settings. Provides targeted light output to initiate chemical curing process of dental restorative materials. Benefits include efficient, specific-wavelength polymerization compared to broad-spectrum halogen lights.

Clinical Evidence

Bench testing only.

Technological Characteristics

Blue LED light source; wavelength range 440-490nm; handheld form factor; intended for polymerization of CPQ-containing dental materials.

Indications for Use

Indicated for dental professionals to polymerize light-curing dental materials containing camphor quinine (CPQ) using high-intensity blue light (440-490nm).

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Guilin Woodpecker Medical Instrument company, Limited C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW Buffalo, Minnesota 55313

MAR 1 9 2008

Re: K080025

Trade/Device Name: Dental Curing Light Models LED.L, LED.M, LED.G, LED.B Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: March 8, 2008 Received: March 10, 2008

Dear Mr. Job:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Mr. Job

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sween Quoser

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: Dental Curing Light Models LED.L, LED.M, LED ... G, LED.B

Indications For Use:

WOODPECKER Curing light LED.L., LED.M, LED.G LED.B with blue LED is a device which generates high intensity light for polymerization of light-curing materials used for dental curing purpose. Unlike Halogen light generating full light spectrum, it only emits light with wavelength primarily in the range of 440 to 490nrn. This is the applicable range for dental Curing of camphor quinine (CPQ) containing products.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Susan Runne

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K080605