Dental Curing Lights - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff
Published: 2026-09-02
Status: Final Type: Guidance Document Category: Premarket (510(k) / PMA / De Novo / IDE) Topics: Premarket, 510(k), Dental Docket: FDA-2024-D-2512
Official Source
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/dental-curing-lights-premarket-notification-510k-submissions PDF: https://www.fda.gov/media/74206/download
Official Full Text
Dental Curing Lights – Premarket Notification (510(k)) Submissions ______________________________________________________________________________
This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff or Office responsible for this guidance as listed on the title page.
I. Introduction
This guidance document provides recommendations for 510(k) submissions for dental curing lights. The devices in the scope of this guidance emit non-ionizing optical radiation intended to photopolymerize dental restorative resins. FDA is issuing this guidance to clarify and provide recommendations for premarket submissions for dental curing lights, as well as reference relevant consensus standards. The recommendations are intended to promote consistency and facilitate efficient review of these submissions.
This document supplements other FDA documents regarding the specific content requirements and recommendations of a premarket notification (510(k)) submission. You should also refer to 21 CFR 807.87 and FDA’s guidance, “Electronic Submission Template for Medical Device 510(k) Submissions.”
For the current edition of the FDA-recognized consensus standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database. If submitting a Declaration of Conformity to a recognized standard, we recommend you include the appropriate supporting documentation. For more information regarding use of consensus standards in regulatory submissions, please refer to the FDA guidance titled “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.”
In general, FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
II. Scope
The scope of this document is limited to dental curing lights regulated under 21 CFR 872.6070 and with the product code listed in the table below:
Table 1: Applicable Product Code Product Code Product Code Name Regulation Number EBZ Activator, Ultraviolet, for Polymerization 21 CFR 872.6070
This guidance also applies to dental curing lights using broad beam and monochromatic light sources that have been classified under this regulation.
The scope of this document does not include laser devices for polymerization such as those regulated under 21 CFR 878.4810 or under 21 CFR 872.6070 with the product code QNF and devices that use heat, light, or other energy sources exclusively for tooth whitening (bleaching) procedures. Devices intended exclusively for tooth bleaching are class I exempt regulated under 21 CFR 872.6475, with product code EEG.
III. Premarket Submission Recommendations
A. Device Description
We recommend that you identify your device by the regulation number and product code indicated in Section II above and include the information described below.
As part of the device description, we recommend that you provide a complete description of all components, patient contacting materials, and features of the dental curing light devices, including the following information: • Labeled images and/or illustrations of all components that comprise the device; • Descriptions of any accessories and/or protective equipment that are packaged with the device, e.g., radiometer, filters, shields, light guides, protective filter glasses; • Engineering drawings and/or schematics of the interior of the device, particularly the light assembly; • Descriptions of the power source, battery type, capacity, and electrical characteristics (e.g., frequency, voltage); • Descriptions of the light source, number and placement of light sources (particularly for LEDs), and wattage; and • Descriptions of all operational modes and any controls, sensors, or alarms.
B. Predicate Comparison
For devices reviewed under the 510(k) process, manufacturers must compare their new device to a similar legally marketed predicate device to support its substantial equivalence (section 513(i) of the Federal Food, Drug and Cosmetic Act (FD&C Act); 21 CFR 807.87(f)). This comparison should provide information to show how your device is similar to and different from the predicate. Side by side comparisons, whenever possible, are desirable. See below for an example of how this information may be organized. This table is not intended to represent an exhaustive list of comparative parameters; ensure you provide all relevant device descriptive and performance characteristics. Table 2: Sample predicate comparison table to outline differences and similarities between the subject and predicate devices Description Subject Device Predicate Device (Kxxxxxx) Indications for use Operational modes Light source Power source Accessories Maximum light intensity (or irradiance) (mW/cm2) Radiant power output (or radiant flux) (mW) Peak wavelength (nm) Radiant exposure output range (J/cm2) Composition of patient-contacting portions of device Other relevant characteristics
C. Labeling
The premarket notification must include proposed labeling in sufficient detail to satisfy the requirements of 21 CFR 807.87(e). Proposed labels and labeling, sufficient to describe the dental curing light, its intended use, and the directions for use must be provided. As prescription devices, dental curing lights are exempt from the requirement to have adequate directions for lay use required under section 502(f)(1) of the FD&C Act as long as the conditions in 21 CFR 801.109 are met. For instance, to be so exempt, labeling that furnishes information for use of the prescription device must, among other things, contain adequate information for such use, including indications, effects, routes, methods, and frequency and duration of administration and any relevant hazards, contraindications, side effects, and precautions, under which practitioners licensed by law to employ the device can use the device safely and for the purposes for which it is intended (21 CFR 801.109(d)). We recommend that the instructions for use include the following information: • Total radiant power output (or radiant flux) (mW) throughout the exposure cycle; • Maximum light intensity (or irradiance) (mW/cm2); • Peak wavelength (nm); • Radiant exposure (or optical radiation dose) output range (J/cm2); • Recommended distance (mm) and angle (degrees) of use from the tooth surface; • Instructions for the use of disposable sleeves for non-patient contacting portions of the device, as applicable; • Instructions for the use of protective equipment such as shields, filter glasses, etc., as applicable, in accordance with the currently FDA-recognized versions of ISO 12609-1 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications – Part 1: Specification for products and ISO 12609-2 Eyewear for protection against intense light sources used on humans and animals for cosmetic and medical applications – Part 2: Guidance for use; • Instructions on how to periodically check the irradiance output; • Warnings about thermal hazards; and • Reuse information as described in FDA guidance “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.” Specifically, we recommend that your instructions for reprocessing address disassembly, cleaning, disinfection/sterilization, and reassembly of the device.
D. Reprocessing
Significance: Many of the patient contacting components of dental curing lights are reused, and should be adequately cleaned, disinfected and sterilized between uses to minimize infections while preventing device degradation.
Recommendation: Instructions on how to reprocess a reusable device are critical to ensure that a device is appropriately prepared for its initial and subsequent uses. For recommendations regarding the development and validation of reprocessing instructions in your proposed device labeling, refer to FDA’s guidance “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.”
E. Biocompatibility
Significance: Dental curing lights contain patient-contacting materials, which, when used for their intended purpose, (i.e., contact type and duration), may induce a harmful biological response.
Recommendation: You should determine the biocompatibility of all patient-contacting materials present in your device. If your device is identical in chemical composition, manufacturing and processing methods to dental curing lights with a history of safe use, you may reference previous testing experience or the literature, if appropriate. For some device materials, it may be appropriate to provide a reference to either a recognized consensus standard, or to a Letter of Authorization (LOA) for a device Master File (MAF). You should refer to the following FDA webpage for additional information on using device MAFs: https://www.fda.gov/medicaldevices/premarket-approval-pma/master-files.
If you are unable to identify a legally marketed predicate device with the same nature of contact and contact duration that uses the same materials and manufacturing process as used in your device, we recommend you conduct and provide a biocompatibility evaluation as described in ISO 7405 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry for the endpoints outlined below. Per FDA’s guidance “Use of International Standard ISO 10993-1, ‘Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process’,” when FDA-recognized consensus standards exist for a particular device type, the biocompatibility recommendations in the device-specific consensus standard should be used instead of the recommendations outlined in ISO 10993-1. The biocompatibility evaluation should explain the relationship between the identified biocompatibility risks, the information available to mitigate the identified risks, and any knowledge gaps that remain. You should then identify any biocompatibility testing or other evaluations that were conducted to mitigate any remaining risks. We recommend that you consider the recommendations in the guidance or the standard, which identifies the types of biocompatibility assessments that should be considered and recommendations regarding how to conduct related tests.
Per ISO 7405 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry or ISO 10993-1 Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process and Attachment A of FDA’s guidance on ISO-10993-1, dental curing lights are surface devices for a limited contact duration.
The following endpoints should be addressed in your biocompatibility evaluation: • cytotoxicity; • sensitization; and • irritation or intracutaneous reactivity.
F. Software
Significance: Device software function(s) in dental curing lights ensures control of the operation and output of the curing light. Adequate software testing provides assurance that the device functions as intended.
Recommendation: Refer to the FDA premarket device software functions guidance “Content of Premarket Submissions for Device Software Functions” for a discussion of the software information that you should provide in your submission. The guidance outlines the recommended information to be provided in a premarket submission that includes a device software function based on the “Documentation Level” associated with the device. We generally consider the device software function(s) for dental curing lights to need a “Basic” Documentation Level. However, new or unusual indications, applications, or technological characteristics may result in an Enhanced Documentation Level.
We recommend that you provide a full description of the device software function(s) supporting the operation of the subject device following this software guidance. This recommendation applies to original devices/systems as well as to any software changes made to already-marketed devices. Changes to software must be revalidated and reverified in accordance with ISO 13485:2016 Clause 7.3.9, Control of design and development changes, and documented in the Design and development files, ISO 13485:2016 Clause 7.3.10 and according to Documentation requirements, ISO 13485 Clause 4.2.1 Some software changes may warrant the submission of a new 510(k). For further information on this topic, refer to “Deciding When to Submit a 510(k) for a Software Change to an Existing Device.”
If the device includes off-the-shelf software, you should provide the additional information as recommended in the FDA guidances “Off-the-Shelf Software Use in Medical Devices,” and “Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions,” which provide additional information regarding medical devices utilizing off-the-shelf software.
If the device is a multiple function device product and includes software function(s) that are considered “other functions,” as that term is used in the guidance “Multiple Function Device Product: Policy and Considerations,” the recommendations described in the aforementioned guidance should also be considered when preparing the software documentation for a premarket submission.
Overall, documentation related to device software function(s) should provide sufficient evidence to describe the role of the software in the context of the device’s intended use and testing to demonstrate that the software functions as designed.
G. Cybersecurity
Significance: Dental curing lights contain software or firmware and have the ability to connect to the internet either directly or indirectly through the connectivity features present in the device design. Failure to maintain cybersecurity can result in risks such as compromised device functionality, loss of device availability, loss of data (medical or personal) availability or
1 FDA issued a final rule that took effect on February 2, 2026, and amends the majority of the requirements previously in 21 CFR Part 820 (Part 820) and incorporates by reference the 2016 edition of the International Organization for Standardization (ISO) 13485, Medical devices - Quality management systems – Requirements for regulatory purposes, in Part 820. As stated in the final rule, the requirements in ISO 13485 are, when taken in totality, substantially similar to the requirements of the previous Part 820, providing a similar level of assurance in a firm’s quality management system and ability to consistently manufacture devices that are safe and effective and otherwise in compliance with the FD&C Act. See 89 FR 7496. integrity, or exposure of other connected devices or networks to security threats. This in turn may have the potential to result in patient injury.
Recommendation: If the device meets the definition of a cyber device under section 524B(c) of the FD&C Act, cybersecurity documentation under section 524B(b) of the FD&C Act is required as a part of the premarket submission. Refer to the FDA cybersecurity guidance “Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions,” for a discussion of the cybersecurity documentation that you should provide in your submission.
H. Electrical Safety and Electromagnetic Compatibility (EMC)
Significance: Dental curing lights are medical electrical equipment and therefore may expose the operator and patient to hazards associated with the use of electrical energy or may fail to operate properly in the presence of electromagnetic disturbance. Recommendation: Dental curing lights should be tested to demonstrate that they perform as anticipated in their intended use environment. We recommend that this testing be performed as described in the currently FDA-recognized versions of the following standards for medical electrical equipment safety and electromagnetic compatibility: • IEC 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance (with relevant U.S. national differences applied) • IEC 80601-2-60 Medical electrical equipment – Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment, as applicable • IEC 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests If submitting a Declaration of Conformity to the above standards, we recommend that appropriate supporting documentation2 be provided. Information regarding test methods chosen and acceptance criteria should be provided because this series of standards includes general methods with multiple options and, in some cases, does not include specific acceptance criteria. For additional information on providing electromagnetic compatibility information in a premarket submission, see FDA’s guidance, “Electromagnetic Compatibility (EMC) of Medical Devices.”
I. Wireless Technology
Significance: In the design, testing, and use of wireless medical devices, the correct, timely, and secure transmission of medical data and information is essential for the safe and effective use of medical devices and systems.
Recommendation: If your dental curing light incorporates radiofrequency wireless technology such as Bluetooth, IEEE 802.11 (Wi-Fi) or RFID (radio frequency identification) technology, testing beyond what is specified in the IEC 60601 standards is recommended to demonstrate that the wireless device functions will perform as intended in environments with other wireless products.
We recommend that you consult FDA’s guidance “Radio Frequency Wireless Technology in Medical Devices” for additional recommendations on this topic.
J. Non-Clinical Performance Testing
Non-clinical performance testing is recommended for dental curing lights to fully characterize the device. Descriptive characteristics alone are not sufficient to ensure that the devices can perform as intended for the end user. For information on the recommended content and format of test reports for the testing described in this section, refer to FDA’s guidance, “Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions.” (1) Radiant power output Significance: Radiant power output (radiant flux) is a measure of the ability of dental curing lights to photopolymerize dental restorative resins. Inadequate radiant power output from dental curing lights can result in incomplete curing of dental restorative resins and lead to premature failure of the restorative material. Excessive radiant power output can result in a thermal hazard for both the patient and the provider. Testing on the type, amount, and uniformity of radiant power output provides assurance that the dental curing light will provide the appropriate amount of energy for its intended purpose.
Recommendation: We recommend that you characterize the radiant power output delivered by the dental curing light source using test methods that conform to the following currently FDArecognized consensus standard, ISO 10650 Dentistry – Powered Polymerization Activators.
We recommend that you provide the results of testing that characterizes the radiant power output of your dental curing light. We recommend that you provide the following information: • Total radiant power output (or radiant flux) (mW) throughout the total exposure cycle; • Maximum light intensity (or irradiance) (mW/cm2) measured at the distal end (tip) of the device light guide; • Total spectral irradiance (mW/cm2 • nm-1) plot at maximum irradiance output (mW/cm2) versus wavelength (nm) at the tip of the device light guide showing the peak wavelength (nm) and ultraviolet wavelengths (i.e., < 380 nm); • Radiant exposure (or optical radiation dose) output range (J/cm2) calculated by multiplying irradiance (mW/cm2) outputs of the various curing modes by recommended curing times (s); • Irradiance attenuation plot, which is the irradiance (mW/cm2) versus vertical distance (from 0 mm to 10 mm at 2 mm increments) from the device light guide tip; and • Thermal image or beam profiler of cross section of light guide tip at maximum radiant exitance showing relative “hot” and “cold” spots across lateral surface of the device light guide tip. (2) Heat generation Significance: Heat generation is the ability of dental curing lights to accumulate heat during normal operation. Excessive heat generation by the dental curing light can present a thermal hazard to the patient and the practitioner. Testing on heat generated during normal operation helps ensure that the dental curing light will not present a thermal hazard when used for its intended purpose.
Recommendation: We recommend that you provide data to demonstrate that during normal and single fault conditions, the temperature generated by the device remains safe for both the patient and the practitioner. This would include heat generated within the body of the device and at the distal tip. We recommend that you identify the maximum temperature (°C) of the body of the device and at the tip of the device under normal and single fault conditions when operated under the worst-case scenario, i.e., for the highest radiant exposure (J/cm2), after a clinically relevant curing time. We recommend that the maximum temperature during normal use conform with the protection against excessive temperature specifications following currently FDA-recognized consensus standard IEC 80601-2-60 Medical electrical equipment - Part 2-60: Particular requirements for the basic safety and essential performance of dental equipment.
IV. Modifications
21 CFR 807.81(a)(3) provides that a device change or modification “that could significantly affect the safety or effectiveness of the device” or represents a “major change or modification in the intended use of the device” requires a new 510(k).3 For additional details, see FDA guidances
3 Section 3308 of the Food and Drug Omnibus Reform Act of 2022 (FDORA), enacted as part of the Consolidated Appropriations Act, added section 515C “Predetermined Change Control Plans for Devices” to the FD&C Act (Pub.
L. No. 117-328). Section 515C has provisions regarding predetermined change control plans (PCCPs) for devices
requiring premarket approval or premarket notification. For example, section 515C states that supplemental applications (section 515C(a)) and new premarket notifications (section 515C(b)) are not required for a change to a device that would otherwise require a premarket approval supplement or new premarket notification if the change is “Deciding When to Submit a 510(k) for a Change to an Existing Device” and “Deciding When to Submit a 510(k) for a Software Change to an Existing Device.”
consistent with a PCCP approved or cleared by FDA. Section 515C also states that FDA may require that a PCCP include labeling for safe and effective use of a device as such device changes pursuant to such plan, notification requirements if the device does not function as intended pursuant to such plan, and performance requirements for changes made under the plan. If you are interested in proposing a PCCP in your marketing submission, we encourage you to submit a Pre-Submission to engage in further discussion with CDRH. See FDA’s guidance “Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program.” Guidance History* Date Description Level 1 Final Guidance September 2026 See Notice of Availability for more information.** “This guidance supersedes the final guidance titled “Dental Curing Lights - Premarket Notification [510(k)] Submissions” and published March 2006.” Reissued as Level 1 Draft Guidance July 2024 See Notice of Availability for more information.** Level 1 Final Guidance March 2006 See Notice of Availability for more information.** *This table was implemented, beginning September 2026 and previous guidance history may not be captured in totality.
Footnotes
[^2]: For more information on Declarations of Conformity and on appropriate supporting documentation, refer to FDA’s guidance “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.”