-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 transillumination to help locate crown fractures, posterior and anterior caries, and for use as an auxiliary light source for endodontic procedures.

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.

AI/ML Overview

This document is a 510(k) summary for the "SmartLite®Pro Modular LED Curing Light," which explicitly states that no clinical performance data has been included. Therefore, it is not possible to describe acceptance criteria or a study proving device performance in the context of human clinical data or AI performance metrics.

However, the document does list Non-Clinical Performance Data and outlines various tests conducted to support substantial equivalence. I can present the information related to the engineering and safety performance of the device based on the provided text.

Here's a breakdown of the non-clinical performance data and related information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

Since detailed numerical acceptance criteria and specific reported performance values are not provided in a comparative table for each test, I will infer what "acceptance criteria" likely refers to (e.g., meeting a standard's requirements or conforming to an internal method) and list the tests that were performed to demonstrate that the device met these criteria.

Acceptance Criteria (Implied)	Reported Device Performance
For Curing Functionality:
Power Output (Cure Tip, PolyCure Tip): Internal test method and acceptance criteria.	Testing was conducted to verify Output Power (Cure Tip) and Output Power (PolyCure Tip). The device "satisfactorily met the requirements."
Depth of Cure (Cure Tip, PolyCure Tip): Conformance to ISO 4049: (Dentist - Polymer-based restorative materials).	Testing was conducted to compare Depth of Cure of Cure Tip, PolyCure Tip, and primary predicate (K061341) per ISO 4049. The device "satisfactorily met the requirements."
Irradiance over Distance (Cure Tip, PolyCure Tip): Internal test method and acceptance criteria.	Testing was conducted to compare Irradiance over Distance of Cure Tip, PolyCure Tip, and primary predicate (K061341). The device "satisfactorily met the requirements."
For Illumination Functionality:
Output Power (Illuminate Tip): Internal test method and acceptance criteria.	Testing was conducted to verify Output Power (Illuminate Tip). The device "satisfactorily met the requirements."
For General Device Safety & Performance:
Electrical Safety: Conformity to IEC 60601-1.	Testing was conducted to verify the conformity of the proposed SmartLite®Pro Modular LED Curing Light with the requirements of IEC 60601-1. The device "satisfactorily met the requirements."
Electromagnetic Compatibility (EMC): Conformity to IEC 60601-1-2.	Testing was conducted to verify the conformity of the proposed SmartLite®Pro Modular LED Curing Light with the requirements of IEC 60601-1-2. The device "satisfactorily met the requirements."
Dental Equipment Safety: Conformity to IEC 80601-2-60.	Testing was conducted to verify the conformity of the proposed SmartLite®Pro Modular LED Curing Light with the requirements of IEC 80601-2-60. The device "satisfactorily met the requirements."
Usability (Engineering): Conformity to IEC 60601-1-6 and IEC 62366.	Testing to verify conformity to IEC 60601-1-6 and a usability study conducted in conformity with IEC 62366. The device "satisfactorily met the requirements."
Biocompatibility: Conformity to ISO 10993-5 (Tests for cytotoxicity).	Biocompatibility assessment of patient contacting components according to the requirements of ISO 10993-5. The device "satisfactorily met the requirements."
Software Validation: Conformity to IEC 62304.	Validation of the devices' software in conformity with IEC 62304. The device "satisfactorily met the requirements."

The following sections are NOT applicable based on the provided document, as it explicitly states NO clinical data was included and does not pertain to AI/machine learning medical devices.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable for clinical studies.
For non-clinical bench testing, specific sample sizes for each test are not provided. The data provenance would be internal Dentsply Sirona laboratories, presumably in the USA (where the company address is listed for the submission).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable for clinical studies.
For non-clinical testing, ground truth is established by standardized methods (e.g., ISO standards) or internal engineering specifications, not by human experts in the way clinical ground truth is established.

4. Adjudication Method for the Test Set

Not applicable for clinical studies.
Not relevant for non-clinical bench testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with vs. without AI Assistance

No, this is not an AI/machine learning device. This is a dental curing light/illuminator.
Therefore, an MRMC study and AI assistance effect size are not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, this is not an AI/machine learning device. This is a dental curing light/illuminator.
Therefore, standalone algorithm performance is not applicable.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Not applicable for clinical ground truth.
For non-clinical testing, the "ground truth" is typically defined by the specified requirements of the relevant IEC/ISO standards or the internal design specifications of the device.

8. The Sample Size for the Training Set

Not applicable. This device does not employ machine learning and therefore has no training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. This device does not employ machine learning and therefore has no training set or associated ground truth establishment method.

Summary

{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.

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."

{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.

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

Image /page/4/Picture/1 description: The image shows the logo for Dentsply Sirona. The logo consists of a stylized leaf-like shape on the left, followed by the words "Dentsply" and "Sirona" stacked on top of each other on the right. The text and the leaf are in a dark gray color. The logo is simple and modern.

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 PredicateDevices	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 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 DeviceSmartLite®Pro ModularLED Curing Light(K191865)	PrimaryPredicate DevicePalmlight 10(K061341)	Differences
Indications for Use	Indications for Use:
For light activatedpolymerization of dentalmaterials such ascomposites, luting cements,and sealants using visiblelight.	For light activatedpolymerization of dentalmaterials such as composites,luting cements, adhesives, andsealants using visible andnear-UV light.	Narrowing for the indications for useof the proposed device. With theproposed device, polymerization ofdental materials if performed usingvisible light only where the primarypredicate uses visible and near-UVlight.Proposed device does not includedental adhesives.
Features:	Features:	Differences
Cordless design withexchangeable battery pack.The exchangeable batterypacks can be charged on acharging base.	Option to be used cordless(battery powered) or corded(connected to mains)Rechargable lithium ionbatteries for the charging baseso the charging base may beused un-corded	The proposed device does not offercorded back up. The proposeddevice can only be powered usingthe exchangeable battery pack. Theproposed device's charging base canonly be used while connected to themains.
Individually removable androtatable LED tips	360° rotating LED tip	Both the proposed device andprimary predicate device LEDtips can be rotated. The primarypredicate device tip cannot beremoved.
Up to 10 seconds curing timeper activation with audiblesignal at start and end ofcycle	- Adjustable timer (5, 10, 15,20 sec) with countdowndisplay- Audible signals confirmbutton presses to select themode and time, and every 5sec during the curing process	The proposed device does not offermultiple options for curing cycleduration.
Software limits LED tiptemperature. Providesaudible warnings whendevice tip reaches criticaltemperature and turns off.	Software monitors thetemperature of the unit and theunit turns off when thetemperature at the wand tipreaches 48°C to minimizeexposure of personnel andpatients to excessivetemperatures	The proposed device has audiblewarnings when the device reachesthe maximum temperature comparedto the primary predicate which justturns off.
Wide spectral output rangefrom 405-480 nm	Wide spectral output rangefrom 400-460 nm	The proposed device has a highermaximum wavelength than itsprimary predicate Palmlight 10.
Proposed Device	Reference Device	Reason for Reference Device
SmartLite®Pro ModularLED Curing Light(K191865)	Bluephase® Style(K110756)
Wide spectral outputrange from 405-480 nm	Wide spectral outputrange from 430-490 nm.	To address the wider spectraloutput generated by the proposedSmartLite®Pro Modular LEDCuring Light, in comparison to itsprimary 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 ModularLED Curing Light	Microlux Transilluminator(K062961)
Indications for Use	Indications for Use:
For intraoral illumination usedupon initial examination ofthe dental patient and dentaltransillumination to helplocate crown fractures,posterior and anterior caries,and for use as an auxiliarylight source for endodonticprocedures.	The Microlux Transilluminatoris a device used upon initialexamination of the dentalpatient to help locate crownfractures, posterior andanterior caries.The microlux Transilluminatoris a screening device used tohelp locate caries and crownfractures. It also functions asan auxiliary light source to aidin operative procedures andpreventive dentistry.	The intraoral illumination ofendodontic access and root canalorifices in the indications for use ofthe subject device are proposed as amore narrowly scoped use which iswithin the cleared indications for useof the primary predicate device as an"auxiliary light source to aid inoperative procedures and preventivedentistry".
Features:	Features:	Differences
Cordless design withexchangeable battery pack.The exchangeable batterypacks can be charged on acharging base.	Option to be used cordless(battery powered) or corded(connected to mains)Rechargeable lithium ionbatteries for the charging baseso the charging base may beused up-corded	The proposed device does not offercorded back up. The proposeddevice can only be powered usingthe exchangeable battery pack. Theproposed device's charging base canonly be used while connected to themains.

{8}------------------------------------------------

Table 5.2 (continued)
Proposed DeviceSmartLite®Pro ModularLED Curing Light	Primary Predicate DeviceMicrolux Transilluminator(K062961)	Differences
Features:	Features:	Differences
LED tip with 1.5 mm outputdiameter	Available glass light guideswith 2 mm and 3 mmoutput diameter.	The proposed device has a tip with asingle output diameter.
Two output powers tovisualize anterior or posteriordental anatomy	Single output power tovisualize dental anatomy	The proposed device has the optionfor 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.

Regulation Number and Section

§ 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.