LED Curing Light GT-2000

K153078 · Monitex Industrial Co., Ltd. · EBZ · Jun 28, 2016 · Dental

Device Facts

• Record ID: K153078
• Device Name: LED Curing Light GT-2000
• Applicant: Monitex Industrial Co., Ltd.
• Product Code: EBZ · Dental
• Decision Date: Jun 28, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

This "LED Curing Light GT-2000" is a dental curing unit utilizing visible light programmed for the polymerization of light curing materials in the wavelength range of 360-420 nm and 420-490 nm by dental professionals.

Device Story

LED Curing Light GT-2000 is a dental device used by dental professionals to polymerize light-curing materials. Device emits visible light in two wavelength ranges (360-420 nm and 420-490 nm) to initiate polymerization of dental resins. Operated by clinicians in dental office settings to harden restorative materials. Benefits include efficient curing of dental composites and adhesives.

Clinical Evidence

Bench testing only.

Technological Characteristics

Dental curing unit; LED light source; dual wavelength output (360-420 nm and 420-490 nm); handheld form factor; electrical power source.

Indications for Use

Indicated for dental professionals to polymerize light-curing dental materials using visible light in the 360-490 nm wavelength range.

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 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 28, 2016

Monitex Industrial Co., Ltd. Shu-Lung Wang President 6F, 70 Sec. 1 Guang-Fu Road Sanchong Dist. New Taipei City, 241-58 Taiwan

Re: K153078

Trade/Device Name: LED Curing Light GT-2000 Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator For Polymerization Regulatory Class: II Product Code: EBZ Dated: May 11, 2016 Received: May 11, 2016

Dear Shu-Lung 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. 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 devicerelated adverse events) (21 CFR 803); 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.

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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 yours,

Tina Kiang
S

for Erin I. Keith, M.S. 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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## Indications for Use

510(k)Number (if Known): K153078 Device Name: LED Curing Light GT-2000 Indications For Use:

This "LED Curing Light GT-2000" is a dental curing unit utilizing visible light programmed for the polymerization of light curing materials in the wavelength range of 360-420 nm and 420-490 nm by dental professionals.

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)

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