(131 days)
No
The summary describes a standard LED curing light and transilluminator with no mention of AI, ML, image processing, or any data processing that would suggest the use of such technologies. The performance studies focus on light output, depth of cure, and electrical/usability standards.
Yes
The device is used for light-activated polymerization of dental materials, which is a therapeutic intervention, and also for illumination to help locate dental issues like crown fractures and caries, aiding in diagnosis and treatment.
No
The device is primarily a polymerization tool, but it also has an "Intended Use" for "intraoral illumination used upon initial examination of the dental transillumination to help locate crown fractures, posterior and anterior caries". This function is diagnostic as it aids in identifying dental pathologies.
No
The device description explicitly states it is a "cordless pen-style, LED light polymerization and illumination device," indicating it is a hardware device with integrated software, not a software-only device. The performance studies also detail testing of hardware components like output power and depth of cure.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses are for light-activated polymerization of dental materials and for intraoral illumination for examination and procedures. These are direct interactions with the patient's body or materials being applied to the patient's body, not testing of samples taken from the body.
- Device Description: It's described as a light polymerization and illumination device for use by dental professionals. This aligns with a therapeutic or diagnostic imaging/illumination device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
- Performance Studies: The performance studies focus on light output, depth of cure, irradiance, electrical safety, usability, and biocompatibility. These are typical performance metrics for a medical device used in a clinical setting, not for an IVD which would focus on analytical and clinical performance related to sample testing.
- Predicate Devices: The predicate devices are other dental curing lights and transilluminators, which are not IVDs.
In summary, the device's function, intended use, and the nature of the performance testing all indicate that it is a medical device used directly in the dental setting for treatment and examination, not an in vitro diagnostic device used for testing samples outside the body.
N/A
Intended Use / Indications for Use
-For light activated polymerization of dental materials such as composites, luting cements. and sealants using visible light.
-For intraoral illumination used upon initial examination of the dental patient and dental transillumination to help locate crown fractures, posterior and anterior caries, and for use as an auxiliary light source for endodontic procedures.
Product codes (comma separated list FDA assigned to the subject device)
EBZ, NTK
Device Description
The proposed SmartLite®Pro Modular LED Curing Light is a cordless pen-style, LED light polymerization and illumination device for use by dental professionals in dental offices or dental laboratories.
The proposed SmartLite®Pro Modular LED Curing Light is characterized by:
- · Small size and lightweight ergonomic design.
- Compact cordless design with convenient handling features and exchangeable battery pack.
- Individually adjustable LED tips, rotatable by 360°.
- · LED tip design providing excellent intra-oral access.
- · Polymerization area (optic effective cross-sectional area) of 10 mm in diameter.
- Up to 10 seconds curing time per activation with audible signal at start and end of cycle.
- · Advanced heat management system limiting LED tiptemperature.
- Exchangeable tips for:
- curing of CQ initiated materials.
- curing of materials with initiators absorbing in the violetrange.
- intraoral illumination and dental transillumination.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professionals in dental offices or dental laboratories.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing of the SmartLite®Pro Modular LED Curing Light was conducted and included in this premarket notification. The results of the performance testing support substantial equivalence. The exchangeable tip used in the test is identified.
The following testing was conducted using the exchangeable tip as identified within the testing, as applicable:
- Testing to verify Output Power (Cure Tip). Internal test method and . acceptance criteria.
- Testing to verify Output Power (PolyCure Tip). Internal test method ● and acceptance criteria.
- Testing to verify Output Power (Illuminate Tip). Internal test method . and acceptance criteria.
- Testing to compare Depth of Cure of Cure Tip, PolyCure Tip, and ● primary predicate (K061341) per ISO 4049: (Dentist - Polymerbased restorative materials).
- . Testing to compare Irradiance over Distance of Cure Tip, PolyCure Tip, and primary predicate (K061341). Internal test method and acceptance criteria.
- . Testing to verify the conformity of the proposed SmartLite®Pro Modular LED Curing Light with the requirements of IEC 60601-1: (Medical electrical equipment Part 1: General requirements for basic safety and essential performance).
- Testing to verify the conformity of the proposed SmartLite®Pro ● Modular LED Curing Light with the requirements of IEC 60601-1-2: (Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance. Collateral Standard: Electromagnetic compatibility).
- Testing to verify the conformity of the proposed SmartLite®Pro ● Modular LED Curing Light with the requirements of IEC 80601-2-60: (Medical electrical equipment Part 2: Particular requirements for basic safety and essential performance of dentalequipment).
- Testing to verify the conformity of the proposed SmartLite®Pro ● Modular LED Curing Light with the requirements of IEC 60601-1-6: (Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance. Collateral Standard: Usability).
- Usability study conducted in conformity with IEC 62366 (Medical . devices - Application of usability engineering to medicaldevices).
- Biocompatibility assessment of patient contacting components of the . proposed SmartLite®Pro Modular LED Curing Light according the requirements of ISO 10993-5 (Biological evaluation of medical devices Part 5: Tests for cytotoxicity).
- Validation of the devices' software in conformity with IEC 62304 . (Medical device software - Software lifecycle processes).
The performance of SmartLite®Pro Modular LED Curing Light satisfactorily met the requirements of the non-clinical bench testing conducted to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
November 20, 2019
Dentsply Sirona Karl Nittinger Vice President, Corporate Regulatory Affairs 221 West Philadelphia Street, Suite 60W York, Pennsylvania 17401
Re: K191865
Trade/Device Name: SmartLite Pro Modular LED Curing Light Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator For Polymerization Regulatory Class: Class II Product Code: EBZ, NTK Dated: July 31, 2019 Received: August 1, 2019
Dear Karl Nittinger:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801; medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191865
Device Name SmartLite® Pro Modular LED Curing Light
Indications for Use (Describe)
-For light activated polymerization of dental materials such as composites, luting cements. and sealants using visible light.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K191865
Device Name SmartLite® Pro Modular LED Curing Light
Indications for Use (Describe)
-For intraoral illumination used upon initial examination of the dental transillumination to help locate crown fractures, posterior and anterior caries, and for use as an auxiliary light source for endodontic procedures.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
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K191865 - 510(k) SUMMARY
for
SmartLite®Pro Modular LED Curing Light
Submitter Information:
Dentsply Sirona 221 West Philadelphia Street Suite 60W York, PA 17401
| Contact Person: | Karl Nittinger |
|---|---|
| Telephone Number: | 717-849-4424 |
| Fax Number: | 717-849-4343 |
Date Prepared:
18-November-2019
Device Name:
.
| • Proprietary Name: | SmartLite®Pro Modular LED Curing Light |
|---|---|
| • Classification Name: | Ultraviolet Activator for Polymerization |
- Ultraviolet Activator for Polymerization Classification Name: Laser Fluorescence Caries Detection Device
| CFR Number: | 872.6070 |
|---|---|
| 872.1745 |
- Device Class: Class II ●
- Product Code: EBZ, NTK .
Primary Predicate Devices:
| Primary Predicate
| Devices | 510(k) | Company Name |
|---|---|---|
| Palmlight 10 | K061341 | CAO Group, Incorporated |
| Microlux Transilluminator | K062961 | AdDent, Incorporated |
Reference Device:
| Reference Device | 510(k) | Company Name |
|---|---|---|
| Bluephase® Style | K110756 | Ivoclar Vivadent, |
| Incorporated |
5
Description of Device:
Dentsply Sirona intends to market the proposed SmartLite®Pro Modular LED Curing Light with an indications for use as a dental curing light as well as a dental illuminator.
Based upon the FDA Guidance, "Bundling Multiple Devices or Multiple Indications in a Single Submission Guidance for Industry and Food and Drug Administration Staff Document", issued on June 22, 2007, bundling, as found in the case of the proposed devices, is acceptable, because one of the bundled devices is an accessory to the other. In the proposed bundled device, two attachments utilize the same handpiece in order to function.
The proposed SmartLite®Pro Modular LED Curing Light is a cordless pen-style, LED light polymerization and illumination device for use by dental professionals in dental offices or dental laboratories.
The proposed SmartLite®Pro Modular LED Curing Light is characterized by:
- · Small size and lightweight ergonomic design.
- Compact cordless design with convenient handling features and exchangeable battery pack.
- Individually adjustable LED tips, rotatable by 360°.
- · LED tip design providing excellent intra-oral access.
- · Polymerization area (optic effective cross-sectional area) of 10 mm indiameter.
- Up to 10 seconds curing time per activation with audible signal at start and end of cycle.
- · Advanced heat management system limiting LED tiptemperature.
- Exchangeable tips for:
- curing of CQ initiated materials.
- curing of materials with initiators absorbing in the violetrange.
- intraoral illumination and dental transillumination.
Indications for Use:
- For light activated polymerization of dental materials such as composites, luting cements, and sealants using visible light.
- For intraoral illumination used upon initial examination of the dental patient and dental transillumination to help locate crown fractures, posterior and anterior caries, and for use as an auxiliary light source for endodontic procedures.
Substantial Equivalence:
Technological Characteristics
Table 5.1 compares the proposed device with the primary predicate device, Palmlight 10(K061341).
6
| Table 5.1 | ||
|---|---|---|
| Proposed Device | ||
| SmartLite®Pro Modular | ||
| LED Curing Light | ||
| (K191865) | Primary | |
| Predicate Device | ||
| Palmlight 10 | ||
| (K061341) | Differences | |
| Indications for Use | Indications for Use: | |
| For light activated | ||
| polymerization of dental | ||
| materials such as | ||
| composites, luting cements, | ||
| and sealants using visible | ||
| light. | For light activated | |
| polymerization of dental | ||
| materials such as composites, | ||
| luting cements, adhesives, and | ||
| sealants using visible and | ||
| near-UV light. | Narrowing for the indications for use | |
| of the proposed device. With the | ||
| proposed device, polymerization of | ||
| dental materials if performed using | ||
| visible light only where the primary | ||
| predicate uses visible and near-UV | ||
| light. | ||
| Proposed device does not include | ||
| dental adhesives. | ||
| Features: | Features: | Differences |
| Cordless design with | ||
| exchangeable battery pack. | ||
| The exchangeable battery | ||
| packs can be charged on a | ||
| charging base. | Option to be used cordless | |
| (battery powered) or corded | ||
| (connected to mains) | ||
| Rechargable lithium ion | ||
| batteries for the charging base | ||
| so the charging base may be | ||
| used un-corded | The proposed device does not offer | |
| corded back up. The proposed | ||
| device can only be powered using | ||
| the exchangeable battery pack. The | ||
| proposed device's charging base can | ||
| only be used while connected to the | ||
| mains. | ||
| Individually removable and | ||
| rotatable LED tips | 360° rotating LED tip | Both the proposed device and |
| primary predicate device LED | ||
| tips can be rotated. The primary | ||
| predicate device tip cannot be | ||
| removed. | ||
| Up to 10 seconds curing time | ||
| per activation with audible | ||
| signal at start and end of | ||
| cycle | - Adjustable timer (5, 10, 15, | |
| 20 sec) with countdown | ||
| display |
- Audible signals confirm
button presses to select the
mode and time, and every 5
sec during the curing process | The proposed device does not offer
multiple options for curing cycle
duration. |
| Software limits LED tip
temperature. Provides
audible warnings when
device tip reaches critical
temperature and turns off. | Software monitors the
temperature of the unit and the
unit turns off when the
temperature at the wand tip
reaches 48°C to minimize
exposure of personnel and
patients to excessive
temperatures | The proposed device has audible
warnings when the device reaches
the maximum temperature compared
to the primary predicate which just
turns off. |
| Wide spectral output range
from 405-480 nm | Wide spectral output range
from 400-460 nm | The proposed device has a higher
maximum wavelength than its
primary predicate Palmlight 10. |
| Proposed Device | Reference Device | Reason for Reference Device |
| SmartLite®Pro Modular
LED Curing Light
(K191865) | Bluephase® Style
(K110756) | |
| Wide spectral output
range from 405-480 nm | Wide spectral output
range from 430-490 nm. | To address the wider spectral
output generated by the proposed
SmartLite®Pro Modular LED
Curing Light, in comparison to its
primary predicate Palmlight 10,
reference device, Bluephase®
Style was added. |
7
Table 5.2 compares the proposed device with the primary predicate device, Microlux Transilluminator (K062961).
| Table 5.2 | ||
|---|---|---|
| Proposed Device | Primary Predicate Device | Differences |
| SmartLite®Pro Modular | ||
| LED Curing Light | Microlux Transilluminator | |
| (K062961) | ||
| Indications for Use | Indications for Use: | |
| For intraoral illumination used | ||
| upon initial examination of | ||
| the dental patient and dental | ||
| transillumination to help | ||
| locate crown fractures, | ||
| posterior and anterior caries, | ||
| and for use as an auxiliary | ||
| light source for endodontic | ||
| procedures. | The Microlux Transilluminator | |
| is a device used upon initial | ||
| examination of the dental | ||
| patient to help locate crown | ||
| fractures, posterior and | ||
| anterior caries. | ||
| The microlux Transilluminator | ||
| is a screening device used to | ||
| help locate caries and crown | ||
| fractures. It also functions as | ||
| an auxiliary light source to aid | ||
| in operative procedures and | ||
| preventive dentistry. | The intraoral illumination of | |
| endodontic access and root canal | ||
| orifices in the indications for use of | ||
| the subject device are proposed as a | ||
| more narrowly scoped use which is | ||
| within the cleared indications for use | ||
| of the primary predicate device as an | ||
| "auxiliary light source to aid in | ||
| operative procedures and preventive | ||
| dentistry". | ||
| Features: | Features: | Differences |
| Cordless design with | ||
| exchangeable battery pack. | ||
| The exchangeable battery | ||
| packs can be charged on a | ||
| charging base. | Option to be used cordless | |
| (battery powered) or corded | ||
| (connected to mains) | ||
| Rechargeable lithium ion | ||
| batteries for the charging base | ||
| so the charging base may be | ||
| used up-corded | The proposed device does not offer | |
| corded back up. The proposed | ||
| device can only be powered using | ||
| the exchangeable battery pack. The | ||
| proposed device's charging base can | ||
| only be used while connected to the | ||
| mains. |
8
| Table 5.2 (continued) | ||
|---|---|---|
| Proposed Device | ||
| SmartLite®Pro Modular | ||
| LED Curing Light | Primary Predicate Device | |
| Microlux Transilluminator | ||
| (K062961) | Differences | |
| Features: | Features: | Differences |
| LED tip with 1.5 mm output | ||
| diameter | Available glass light guides | |
| with 2 mm and 3 mm | ||
| output diameter. | The proposed device has a tip with a | |
| single output diameter. | ||
| Two output powers to | ||
| visualize anterior or posterior | ||
| dental anatomy | Single output power to | |
| visualize dental anatomy | The proposed device has the option | |
| for use of two output powers. |
Non-Clinical Performance Data.
Performance testing of the SmartLite®Pro Modular LED Curing Light was conducted and included in this premarket notification. The results of the performance testing support substantial equivalence. The exchangeable tip used in the test is identified.
The following testing was conducted using the exchangeable tip as identified within the testing, as applicable:
- Testing to verify Output Power (Cure Tip). Internal test method and . acceptance criteria.
- Testing to verify Output Power (PolyCure Tip). Internal test method ● and acceptance criteria.
- Testing to verify Output Power (Illuminate Tip). Internal test method . and acceptance criteria.
- Testing to compare Depth of Cure of Cure Tip, PolyCure Tip, and ● primary predicate (K061341) per ISO 4049: (Dentist - Polymerbased restorative materials).
- . Testing to compare Irradiance over Distance of Cure Tip, PolyCure Tip, and primary predicate (K061341). Internal test method and acceptance criteria.
- . Testing to verify the conformity of the proposed SmartLite®Pro Modular LED Curing Light with the requirements of IEC 60601-1: (Medical electrical equipment Part 1: General requirements for basic safety and essential performance).
- Testing to verify the conformity of the proposed SmartLite®Pro ● Modular LED Curing Light with the requirements of IEC 60601-1-2: (Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance. Collateral Standard: Electromagnetic compatibility).
- Testing to verify the conformity of the proposed SmartLite®Pro ● Modular LED Curing Light with the requirements of IEC 80601-2-60: (Medical electrical equipment Part 2: Particular requirements for basic safety and essential performance of dentalequipment).
9
- Testing to verify the conformity of the proposed SmartLite®Pro ● Modular LED Curing Light with the requirements of IEC 60601-1-6: (Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance. Collateral Standard: Usability).
- Usability study conducted in conformity with IEC 62366 (Medical . devices - Application of usability engineering to medicaldevices).
- Biocompatibility assessment of patient contacting components of the . proposed SmartLite®Pro Modular LED Curing Light according the requirements of ISO 10993-5 (Biological evaluation of medical devices Part 5: Tests for cytotoxicity).
- Validation of the devices' software in conformity with IEC 62304 . (Medical device software - Software lifecycle processes).
The performance of SmartLite®Pro Modular LED Curing Light satisfactorily met the requirements of the non-clinical bench testing conducted to support substantial equivalence.
Clinical Performance Data.
No data from human clinical studies has been included to support the substantial equivalence of the SmartLite® Pro Modular LED Curing Light.
Conclusion Regarding Substantial Equivalence
The SmartLite® Pro Modular LED Curing Light is a light polymerization and illumination device for use by dental professionals. The SmartLite® Pro Modular LED Curing Light has the same intended use, incorporates the same fundamental technology, and has similar indications for use as the primary predicate Palmlight 10 cleared under premarket notification K061341 and the primary predicate Microlux Transilluminator cleared under premarket notification K062961.
The results of the performance testing, combined with the design and intended use comparison with the primary predicate devices, support substantial equivalence.