LED CURING LIGHT

K080035 · Monitex Industrial Co., Ltd. · EBZ · Mar 3, 2008 · Dental

Device Facts

• Record ID: K080035
• Device Name: LED CURING LIGHT
• Applicant: Monitex Industrial Co., Ltd.
• Product Code: EBZ · Dental
• Decision Date: Mar 3, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This" LED Curing Light GT-1200" is for the polymerization of light cure materials.

Device Story

LED Curing Light GT-1200 is a dental device used for polymerization of light-cure materials. Device utilizes LED technology to emit light at specific wavelengths to cure dental resins/composites. Operated by dental professionals in clinical settings. Provides controlled light output to initiate chemical hardening of restorative materials; facilitates dental procedures involving fillings, sealants, or bonding. Benefits include efficient, rapid curing of dental materials compared to traditional methods.

Clinical Evidence

Bench testing only.

Technological Characteristics

LED-based light source for polymerization. Handheld form factor. Operates via electrical power. Class II device under 21 CFR 872.6070 (Product Code EBZ).

Indications for Use

Indicated for polymerization of light-cure dental materials. No specific patient population, age, or gender restrictions provided.

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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## MAR - 3 2008

Mr. Shu-Lung Wang President Monitex Industrial Company, Ltd. 6F, 70 Sec.1 Guang-Fu Road San-Chung City, Taiwan 241-58 REPUBLIC OF CHINA

Re: K080035

Trade/Device Name: LED Curing Light GT-1200 Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Code: EBZ Dated: January 7, 2008 Received: January 7, 2008

Dear Mr. Wang:

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. Wang

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 your 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" (21 CFR 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,

Sottie Y. Michaud.

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

K 080025 510(k)Number(if Know): Device Name: LED Curing Light GT-1200 Indications For Use:

This" LED Curing Light GT-1200" is for the polymerization of light cure materials.

Prescription Use_ (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation(ODE)

Suan Romer

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

510(k) Number: K050035