Guidance for Industry and FDA Staff 
 
Dental Curing Lights - 
Premarket Notification [510(k)] 
Submissions 
 
 
Document issued on: March 27, 2006  
 
 
 
 
For questions regarding this document contact Robert J. Landry of OSEL (301-827-4687 
or Robert.Landry@fda.hhs.gov) or Michael Adjodha of ODE (240-276-3700
or Michael.Adjodha@fda.hhs.gov).  
 
 
 
 
 
 
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
 
Division of Physics 
Office of Science and Engineering Laboratories 
and 
Dental Devices Branch 
Division of Anesthesiology, General Hospital,  
Infection Control, and Dental Devices 
Office of Device Evaluation 
  Contains Nonbinding Recommendations 
 
 
Preface 
 
Public Comment 
Written comments and suggestions may be submitted at any time for Agency consideration 
to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers 
Lane, Room 1061, (HFA-305), Rockville, MD, 20852. 
When submitting comments, please refer to the exact title of this guidance document.  
Comments may not be acted upon by the Agency until the document is next revised or 
updated.   
Additional Copies 
Additional copies are available from the Internet at: 
http://www.fda.gov/cdrh/ODE/guidance/1591.html, or to receive this document by fax, 
call the CDRH Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a 
touch-tone telephone.  Press 1 to enter the system.  At the second voice prompt, press 1 to 
order a document.  Enter the document number (1591) followed by the pound sign (#).  
Follow the remaining voice prompts to complete your request.   
 
  Contains Nonbinding Recommendations 
 
 
Table of Contents 
 
1.  Introduction.............................................................................................................1 
2.  The Least Burdensome Approach...........................................................................1 
3.  Background.............................................................................................................2 
4.  The Content and Format of an Abbreviated 510(k) Submission............................2 
5.  Scope.......................................................................................................................5 
6.  Device Description..................................................................................................5 
7.  Risks to Health........................................................................................................6 
8.  Performance Specifications....................................................................................7 
9.  Electrical Safety and Electromagnetic Compatibility (EMC)................................8 
10.  Infection Control Procedures..................................................................................8 
11.  Labeling..................................................................................................................9 
 
  Contains Nonbinding Recommendations 
 
 
Guidance for Industry and FDA Staff  
 
Dental Curing Lights - Premarket 
Notification [510(k)] Submissions 
 
This guidance represents the Food and Drug Administration's (FDA's) current 
thinking on this topic.  It does not create or confer any rights for or on any person and 
does not operate to bind FDA or the public.  You can use an alternative approach if the 
approach satisfies the requirements of the applicable statutes and regulations.  If you 
want to discuss an alternative approach, contact the FDA staff responsible for 
implementing this guidance.  If you cannot identify the appropriate FDA staff, call the 
appropriate number listed on the title page of this guidance.  
 
1.  Introduction 
FDA has developed this guidance document to assist industry in preparing premarket 
notification submissions for dental curing lights intended for polymerize (set) resinous 
dental pit and fissure sealants or restorative materials by transmission of light through a 
rod (21 CFR 872.6070). 
2.  The Least Burdensome Approach 
The issues identified in this guidance document represent those that we believe need to be 
addressed before your device can be marketed.  In developing the guidance, we carefully 
considered the relevant statutory criteria for Agency decision-making.  We also considered 
the burden that may be incurred in your attempt to follow the guidance and address the 
issues we have identified.  We believe that we have considered the least burdensome 
approach to resolving the issues presented in the guidance document.  If, however, you 
believe that there is a less burdensome way to address the issues, you should follow the 
procedures outlined in the A Suggested Approach to Resolving Least Burdensome 
Issues document.  It is available on our Center web page at 
http://www.fda.gov/cdrh/modact/leastburdensome.html. 
FDAs guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agencys 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.   
  1 Contains Nonbinding Recommendations 
 
 
3.  Background 
A manufacturer who intends to market a device of this generic type should conform 
to the general controls of the Federal Food, Drug, and Cosmetic Act (the act), 
including the premarket notification requirements described in 21 CFR 807 Subpart 
E, and obtain a substantial equivalence determination from FDA prior to marketing 
the device.  (See also 21 CFR 807.81 and 807.87). 
This guidance document identifies the classification regulations and product codes for 
dental curing lights (refer to Section 5.  Scope).  In addition, other sections of this 
guidance document provide additional information to manufacturers on addressing risks 
related to these devices in premarket notifications (510[k]s).  
This document supplements other FDA documents regarding the specific content 
requirements of a premarket notification submission.  You should also refer to 21 CFR 
807.87 and How to Prepare a 510(k) Submission on FDA Device Advice at 
http://www.fda.gov/cdrh/devadvice/314.html. 
Under The New 510(k) Paradigm - Alternate Approaches to Demonstrating 
Substantial Equivalence in Premarket Notifications; Final Guidance, 
http://www.fda.gov/cdrh/ode/parad510.html, a manufacturer may submit a Traditional 
510(k) or has the option of submitting either an Abbreviated 510(k) or a Special 510(k).  
FDA believes an Abbreviated 510(k) provides the least burdensome means of 
demonstrating substantial equivalence for a new device, particularly once FDA has issued 
a guidance document addressing that device.  Manufacturers considering certain 
modifications to their own cleared devices may lessen the regulatory burden by 
submitting a Special 510(k). 
 
4.  The Content and Format of an Abbreviated 510(k) 
Submission  
An Abbreviated 510(k) submission must include the required elements identified in 21 
CFR 807.87, including the proposed labeling for the device sufficient to describe the 
device, its intended use, and the directions for its use.  In an Abbreviated 510(k), FDA 
may consider the contents of a summary report to be appropriate supporting data within 
the meaning of 21 CFR 807.87(f) or (g); therefore, we recommend that you include a 
summary report.  The report should describe how this guidance document was used 
during the device development and testing and should briefly describe the methods or 
tests used and a summary of the test data or description of the acceptance criteria applied 
to address the risks identified in this document, as well as any additional risks specific to 
your device.  This section suggests information to fulfill some of the requirements of 21 
CFR 807.87 as well as some other items that we recommend you include in an 
Abbreviated 510(k). 
  2 Contains Nonbinding Recommendations 
 
Coversheet 
The coversheet should prominently identify the submission as an Abbreviated 510(k) 
and cite the title of this guidance document. 
 
Proposed labeling 
Proposed labeling should be sufficient to describe the device, its intended use, and the 
directions for its use.  (Please refer to Section 11.  Labeling for specific information 
that should be included in the labeling for devices of the types covered by this 
guidance document.) 
 
Summary report 
FDA recommends that the summary report contain: 
 
Description of the device and its intended use   
We recommend that you describe the performance specifications and, when 
appropriate, include detailed, labeled drawings of the device.  (Please refer to 
Section 6.  Device Description for specific information that we recommend you 
include in the device description for devices of the types covered by this guidance 
document.)  You should also submit an indications for use enclosure.1 
 
Description of device design 
We recommend that you include a brief description of the device design 
requirements. 
 
Identification of the risk analysis method 
We recommend that you identify the risk analysis method(s) you used to assess 
the risk profile, in general, as well as the specific devices design and the results 
of this analysis.  (Please refer to Section 7.  Risks to Health for the risks to health 
generally associated with the use of this device that FDA has identified.) 
 
Discussion of the device characteristics  
We recommend that you discuss the device characteristics that address the risks 
identified in this guidance document, as well as any additional risks identified in 
your risk analysis.  
 
                                                 
1 Refer to http://www.fda.gov/cdrh/ode/indicate.html for the recommended format. 
  3 Contains Nonbinding Recommendations 
 
Description of the performance aspects 
We recommend that you include a brief description of the test method(s) you have 
used or intend to use to address each performance aspect identified in Sections 9
11 of this guidance document.  If you follow a suggested test method, you may 
cite the method rather than describing it.  If you modify a suggested test method, 
you may cite the method but should provide sufficient information to explain the 
nature of and reason for the modification.  For each test, you may either (1) 
briefly present the data resulting from the test in clear and concise form, such as a 
table, or (2) describe the acceptance criteria that you will apply to your test 
results.2  (See also 21 CFR 820.30, Subpart C - Design Controls for the Quality 
System Regulation.)   
 
Reliance on standards 
If you choose to rely on a recognized standard for any part of the device design or testing, 
you may include either a:  
  statement that testing will be conducted and meet specified acceptance criteria 
before the device is marketed; or  
  declaration of conformity to the standard.3   
Because a declaration of conformity is based on results from testing, we believe 
you cannot properly submit a declaration of conformity until you have completed 
the testing the standard describes.  For more information, please refer to section 
514(c)(1)(B) of the Act and the FDA guidance, Use of Standards in Substantial 
Equivalence Determinations.4  
 
If it is not clear how you have addressed the risks identified by FDA or additional 
risks identified through your risk analysis, we may request additional information 
about aspects of the devices performance characteristics.  We may also request 
additional information if we need it to assess the adequacy of your acceptance 
criteria.  (Under 21 CFR 807.87(l), we may request any additional information 
that is necessary to reach a determination regarding substantial equivalence.)  
                                                 
2 If FDA makes a substantial equivalence determination based on acceptance criteria, the 
subject device should be tested and shown to meet these acceptance criteria before being 
introduced into interstate commerce.  If the finished device does not meet the acceptance 
criteria and, thus, differs from the device described in the cleared 510(k), FDA 
recommends that submitters apply the same criteria used to assess modifications to 
legally marketed devices (21 CFR 807.81(a)(3)) to determine whether marketing of the 
finished device requires clearance of a new 510(k). 
3 See Required Elements for a Declaration of Conformity to a Recognized Standard 
(Screening Checklist for All Premarket Notification [510(K)] Submissions), 
http://www.fda.gov/cdrh/ode/reqrecstand.html. 
4 http://www.fda.gov/cdrh/ode/guidance/1131.html. 
  4 Contains Nonbinding Recommendations 
 
 
As an alternative to submitting an Abbreviated 510(k), you can submit a Traditional 
510(k) that provides all of the information and data required under 21 CFR 807.87 and 
described in this guidance.  A Traditional 510(k) should include all of your methods, 
data, acceptance criteria, and conclusions.  Manufacturers considering certain 
modifications to their own cleared devices should consider submitting Special 510(k)s. 
 
In general, the discussion above applies to any 510(k).  The following is a specific 
discussion of how you should apply this guidance document to a premarket notification 
submission for dental curing lights. 
 
5.  Scope 
This document applies to dental curing lights for photoactivation of resins and dental 
bleaching agents (class II, product procode EBZ) classified under the following 
regulation. 
 
21 CFR 872.6070  Ultraviolet Activator for Polymerization  
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. 
 
The scope of this guidance includes devices that use light sources such as quartz-
tungsten-halogen lamps, light-emitting diodes (LEDs), and xenon-plasma arcs, as well as 
laser energy sources. 
 
The scope of this guidance does not include heat or light sources intended exclusively 
for tooth bleaching procedures.  These are classified under 21 CFR 872.6475, Heat 
Source for Bleaching Teeth, product code EEG.  These devices are exempt from the 
premarket notification procedures in subpart E of part 807 of this chapter, subject to the 
limitations of 872.9. 
6.  Device Description  
We recommend you identify your device by regulation number and product code 
identified in Section 5.  Scope and include a description of:  
  the principles of operation (i.e., the scientific principles behind how the device 
achieves its intended use) 
  how you plan to market the device (and accessories, if any). 
We recommend you provide information to show how the new device is both similar to 
and different from the legally marketed device.  Side by side comparisons, whenever 
possible, are desirable; for example, using a tabular format as shown below.  We also 
  5 Contains Nonbinding Recommendations 
 
recommend that you describe how any differences may affect the comparative safety and 
effectiveness of your device. 
Table 1:  Device and Predicate Comparison Table 
Descriptive Information  Device   Predicate 
Intended Use - including   
 
specific indications 
Device Design  i.e.,    
operational modes, light 
 
source, power source, and 
accessories 
Composition of Materials    
including chemical 
composition of patient-  
contacting portions of the 
device 
Technical Specifications    
including light intensity, peak   
wavelength, depth of cure 
FDA-Recognized Standards 
 
 list of any you have 
followed, e.g., electrical   
safety, fire safety, EMC, EMI, 
biocompatibility5 
 
7.  Risks to Health 
In the table below, FDA has identified the risks to health generally associated with the 
use of dental curing light devices addressed in this document.  The measures 
recommended to mitigate these identified risks are given in this guidance document, as 
shown in the table below.  You should also conduct a risk analysis to identify any other 
risks specific to your device, and submit the results of this analysis.  If you elect to use an 
alternative approach to address a particular risk identified in this document, or have 
identified risks additional to those in this document, you should provide sufficient detail 
to support the approach you have used to address that risk. 
 
                                                 
5 For the list of FDA-Recognized Standards, see 
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfStandards/search.cfm 
 
  6 Contains Nonbinding Recommendations 
 
Table 2.  Risks and Mitigation Measures 
 
Identified Risk  Recommended Mitigation Measures 
 
Ineffective treatment  Section 8.  Performance Specifications 
Thermal or optical injury  Section 8.  Performance Specifications 
Electrical injury  Section 9.  Electrical Safety and 
Electromagnetic Compatibility 
Electromagnetic interference  Section 9.  Electrical Safety and 
Electromagnetic Compatibility  
Cross-contamination  Section 10.  Infection Control Procedures  
Improper use  Section 11.  Labeling 
 
 
8.  Performance Specifications 
We recommend that you evaluate your dental curing light device using the following 
FDA-recognized standard or equivalent method:  American National 
Standard/American Dental Association (ANSI/ADA) Specification No. 48, Visible 
Light Curing Units, 2004. 
In addition, to demonstrate the equivalence of your dental curing light device to other 
legally marketed devices, we recommend that you describe: 
  irradiance at a distance of 2 mm from the distal end of the light guide at maximum 
light output showing the maximum light intensity (mW/cm2)   
  spectral irradiance plot at a distance of 2 mm from the distal end of the light guide 
at maximum light output showing the peak wavelength (nm) 
  light source type; i.e., halogen, LED, plasma arc, wattage 
  power source; i.e., battery or main power supply 
  curing modes and safety controls 
  depth of cure (mm) on a representative resin sample. 
If your dental curing light is controlled by computer software, we recommend you follow 
the recommendations of the FDA guidance documents below: 
  7 Contains Nonbinding Recommendations 
 
  Guidance for the Content of Premarket Submissions for Software Contained 
in Medical Devices6 
  General Principles of Software Validation.7 
We recommend you demonstrate that the use of your device does not present a thermal 
hazard to the patient.  For example, you may wish to demonstrate that, for the longest 
prescribed curing times, patient contacting portions of the device do not present a thermal 
hazard.  
 
We recommend you demonstrate that the use of your device does not present an optical 
radiation hazard to the patient for the maximum expected exposure time in any single 
area associated with the use of the device; for example, showing that for the longest 
exposure times, the optical radiation emissions from the device do not present hazards. 
 
9.  Electrical Safety and Electromagnetic Compatibility  
We recommend you demonstrate the electrical safety of your device by following both 
FDA-recognized standards below or equivalent methods: 
  American National Standard/American Dental Association (ANSI/ADA) 
Specification No. 48, Visible Light Curing Units, 2004       
  IEC 60601-1:1988, Medical Electrical Equipment  Part 1: General 
requirements for safety. 
We recommend you demonstrate the electromagnetic compatibility (EMC) of your 
device by following the recommendations of the FDA-recognized standards below or 
equivalent methods: 
  American National Standard/American Dental Association (ANSI/ADA) 
Specification No. 48, Visible Light Curing Units, 2004.    
  IEC 60601-1-2:1993, Medical Electrical Equipment  Part 1:  General 
requirements for safety  2. Collateral Standard:  Electromagnetic 
compatibility  Requirements and test 
10. Infection Control Procedures 
Dental curing lights are generally provided to the user as nonsterile devices.  Patient-
contacting portions, such as the light tip, are intended to be disinfected or sterilized 
before each use.  We recommend you describe the parameters for disinfection, 
                                                 
6 http://www.fda.gov/cdrh/ode/guidance/337.html 
7 http://www.fda.gov/cdrh/comp/guidance/938.pdf 
  8 Contains Nonbinding Recommendations 
 
sterilization, or both, as appropriate for your device, and include the validated method, 
suitable chemical disinfectants for the device material type, and the cycle 
variablestime, temperature, pressure.   
11. Labeling 
The premarket notification should include labeling in sufficient detail to satisfy the 
requirements of 21 CFR 807.87(e).  Products using lasers must also comply with 21 CFR 
Sections 1040.10 and 1040.11 and labeled according to 21 CFR 1040.10(g). 
The following suggestions are aimed at assisting you in preparing labeling that satisfies 
the requirements of 21 CFR Part 801.8  We recommend labeling include:    
  maximum light intensity 
  peak wavelength 
  types of curing systems compatible with your device 
  warnings about optical radiation and thermal hazards. 
 
We recommend that the labeling and instructions for use of your device follow the 
recommendations of the FDA guidance:  Labeling Reusable Medical Devices for 
Reprocessing in Health Care Facilities: FDA Reviewer Guidance.9  In particular, the 
instructions for reprocessing should include details for the user on: 
  disassembly 
  cleaning 
  rinsing 
  disinfection/sterilization 
  drying 
  reassembly of the device 
  use of disposable sheathing for other portions of the device. 
 
                                                 
8 Although final labeling is not required for 510(k) clearance, final labeling must comply 
with the requirements of 21 CFR Part 801 before a medical device is introduced into 
interstate commerce.  In addition, final labeling for prescription medical devices must 
comply with 21 CFR 801.109.  Labeling recommendations in this guidance are consistent 
with the requirements of Part 801. 
9 http://www.fda.gov/cdrh/ode/198.pdf 
  9