LED Curing Light

K161855 · Monitex Industrial Co., Ltd. · EBZ · Nov 27, 2017 · Dental

Device Facts

• Record ID: K161855
• Device Name: LED Curing Light
• Applicant: Monitex Industrial Co., Ltd.
• Product Code: EBZ · Dental
• Decision Date: Nov 27, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6070
• Device Class: Class 2

Intended Use

This "LED Curing Light GT-2000 Carbon" 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 Carbon is a dental curing unit; used by dental professionals in clinical settings. Device emits visible light at specific wavelengths (360-420 nm and 420-490 nm) to trigger polymerization of light-curing dental materials. Operation involves manual application by the clinician to the restorative material. Benefits include efficient hardening of dental composites and adhesives.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

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

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

November 27, 2017

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

Re: K161855

Trade/Device Name: Led Curing Light Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator For Polymerization Regulatory Class: Class II Product Code: EBZ Dated: October 30, 2017 Received: October 30, 2017

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.

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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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,

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For Tina Kiang, Ph.D. Acting 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) K161855

Device Name LED Curing Light GT-2000 Carbon

Indications for Use (Describe)

This "LED Curing Light GT-2000 Carbon" 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.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| <span style="font-family: Arial;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: Arial;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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