LED CURING LIGHT, MODEL GT-1500

K091887 · Monitex Industrial Co., Ltd. · EBZ · Sep 18, 2009 · Dental

Device Facts

• Record ID: K091887
• Device Name: LED CURING LIGHT, MODEL GT-1500
• Applicant: Monitex Industrial Co., Ltd.
• Product Code: EBZ · Dental
• Decision Date: Sep 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This" LED Curing Light GT-1500" is for the polymerization of light cure materials.

Device Story

LED Curing Light GT-1500 is a dental device used for polymerization of light-cure materials. Device utilizes LED technology to emit light at specific wavelengths to initiate curing process. Operated by dental professionals in clinical settings. Provides controlled light output to ensure proper hardening of dental restorative materials; benefits patient by facilitating efficient and effective dental restorations.

Clinical Evidence

Bench testing only.

Technological Characteristics

LED-based light source for polymerization; handheld form factor; electrical energy source; class II device under 21 CFR 872.6070.

Indications for Use

Indicated for polymerization of light-cure dental materials in clinical settings.

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 seal of the U.S. Department of Health & Human Services. The seal is circular and contains the department's emblem in the center. The emblem consists of a stylized caduceus, a symbol of medicine, with three horizontal bars representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem.

SFP 1 8 2009

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

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

Re: K091887

Trade/Device Name: LED Curing Light GT-1500 Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator for Polymerization Regulatory Class: II Product Codes: EBZ and EEG Dated: September 15, 2009 Received: September 15, 2009

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 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.

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

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## Page 2 - Mr. Wang

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): 2.1 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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.

for

Susan Runner, D.D.S Acting 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 Know): Device Name: LED Curing Light GT-1500 Indications For Use:

This" LED Curing Light GT-1500" is for the polymerization of light cure materials.

- Prescription Use_ لا -(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)

Rei Mulay for MSA
(Division Sign-Off)

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Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K091887