(611 days)
LED Curing Light LD-M4 . LD-M4P is a dental curing unit utilizing visible light programmed for the polymerization of light curing materials in the wavelength range of 420-490 nm by dental professionals.
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I am sorry, but the provided text from the FDA 510(k) letter for the LED Curing Light LD-M4, LD-M4P (K152192) does not contain the specific information required to answer your request.
This document is a notification of substantial equivalence for a medical device and primarily focuses on regulatory approval. It does not include:
- Acceptance criteria and reported device performance (Table 1): While it states the device cures materials in the 420-490 nm wavelength, it doesn't provide specific performance metrics, quality standards, or the criteria for what would be considered "acceptable."
- Study details: There is no mention of a specific study, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about training sets or how ground truth was established.
The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar technological characteristics and is intended for the same use as a device already on the market. The FDA's substantial equivalence determination does not usually involve a detailed breakdown of a new study's results in the public summary letter, but rather a comparison to an existing device.
To obtain the information you're looking for, you would typically need to consult the full 510(k) submission, which contains the detailed technical and performance data submitted by the manufacturer to the FDA. This information is not typically made public in its entirety, though summaries may be available.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 7, 2017
Monitex Industrial Co., Ltd. Shu-Lung Wang President 6F, 70 SEC. 1 Guang-fu Road San-chong Dist. New Taipei City, 241-58 Taiwan
Re: K152192
Trade/Device Name: LED Curing Light LD-M4, LD-M4P Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator For Polymerization Regulatory Class: Class II Product Code: EBZ Dated: March 8, 2017 Received: March 8, 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
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Michael J. Ryan -S
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 Know): K152192 Device Name: LED Curing Light LD-M4, LD-M4P Indications For Use:
LED Curing Light LD-M4 . LD-M4P is a dental curing unit utilizing visible light programmed for the polymerization of light curing materials in the wavelength range of 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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§ 872.6070 Ultraviolet activator for polymerization.
(a)
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.(b)
Classification. Class II.