The Coltolux Comfort LED Curing Light is indicated for the polymerization of intra- and extraoral dental restorations fabricated from materials (commonly referred to as visible light cured dental restoratives and/or composites and/or dental adhesives) that contain Camphorquinone as the photoinitiator.

Device Description

The proposed Coltolux Comfort LED Curing Light (Coltolux Comfort) is used for the polymerization of light-cured resin materials used in dental restorations. The Coltolux Comfort incorporates a focused high-power LED to produce light in the "deep blue" spectrum (wavelength 440 - 470 nm) for activating Camphorquinone (CQ) photo-initiators. The device is utilized by placement of the lens within close proximity to the surface of the material to be cured, activation of the curing light via the pushbutton switch, and retention of the tip near the dental material until the composite is cured.

AI/ML Overview

The provided text describes the 510(k) summary for the Coltolux Comfort LED Curing Light (K223142). Here's an analysis of the acceptance criteria and study information provided:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly provide a table of acceptance criteria with corresponding device performance for specific quantitative metrics. Instead, it states that "Performance testing was conducted to verify that the proposed Coltolux Comfort Curing Light meets the requirements as defined in FDA Guidance Document 'Dental Curing Lights - Premarket Notification [510(k)' and in accordance with IEC 60601-1-2."

It lists the types of non-clinical tests performed:

Light output uniformity and dropoff testing
Peak wavelength testing (ISO 10650:2018)
Irradiance output (ISO 10650:2018)
Depth of cure
Endurance testing
Light attenuation through barrier sleeve
Light shield filtration
Life testing
Duty cycle (IEC 60601-1:2012)
EMC (IEC 60601-1-2:2014)
Electromagnetic disturbances (IEC 60601-1-2:2014)
Photobiological safety (IEC 62471:2006)

The conclusion states: "Based on the non-clinical performance data the proposed Coltolux Comfort Curing Light is as safe, as effective, and performs as well as or better than the predicate device Coltolux LED Curing Light (K040551, 21 CRF 872.6070, product code EBZ)." This implies that the device met the acceptance criteria defined by the listed standards and guidance documents, but the specific numerical targets and measured results are not detailed in this summary.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document focuses on non-clinical performance testing (bench testing). Therefore, the concept of "test set" in terms of subject data (like in a clinical trial) is not directly applicable. For bench testing, test articles (the devices themselves) are used. The sample size for these component-level tests (e.g., number of devices tested for endurance, light output) is not specified in this summary. The provenance of this bench testing data would typically be the manufacturer's lab, often in the country of origin of the manufacturer (Switzerland) or a contracted testing facility. The nature of these tests is inherently prospective as they are performed specifically to evaluate the new device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is not applicable as the summary describes non-clinical, bench testing of a dental curing light, not an AI or diagnostic device that requires expert ground truth for interpretation of clinical data.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This is not applicable for the same reasons as #3. Adjudication methods are used in clinical studies, particularly for diagnostic devices, to establish a consensus ground truth from expert readings.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. The device is a dental curing light, not an AI-assisted diagnostic or interpretative tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical medical device (a curing light), not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the non-clinical tests, the "ground truth" or reference standards are derived from established international standards (e.g., ISO 10650:2018, IEC 60601-1:2012, IEC 60601-1-2:2014, IEC 62471:2006) and FDA guidance documents. For instance, irradiance output is measured against defined limits or performance of a predicate device according to the ISO standard. Depth of cure would be assessed against a material's known curing characteristics.

8. The sample size for the training set

This is not applicable as the device is not an AI/machine learning product and therefore does not have a "training set" in that context.

9. How the ground truth for the training set was established

This is not applicable for the same reason as #8.

Summary

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December 22, 2022

Dent4You AG Dr. Tricia Cregger Global Regulatory Affairs Manager Bahnhofstrasse 2 Heerbrugg, 9435 SWITZERLAND

Re: K223142

Trade/Device Name: Coltolux Comfort LED Curing Light Regulation Number: 21 CFR 872.6070 Regulation Name: Ultraviolet Activator For Polymerization Regulatory Class: Class II Product Code: EBZ Dated: October 3, 2022 Received: October 4, 2022

Dear Dr. Tricia Cregger:

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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting 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 (QS) 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 medical devices and radiation-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.

Michael E. Adjodha -S

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory. ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K223142

Device Name

Coltolux Comfort LED Curing Light

Indications for Use (Describe)

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)

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510(k) Summary
Contact Details	K223142	21 CFR 807.92(a)(1)
Applicant Name	Dent4You AG
Applicant Address	Bahnhofstrasse 2 Heerbrugg 9435 Switzerland
Applicant Contact Telephone	330-916-8904
Applicant Contact	Dr. Tricia Cregger
Applicant Contact Email	tricia.cregger@coltene.com
Device Name		21 CFR 807.92(a)(2)
Device Trade Name	Coltolux Comfort LED Curing Light
Common Name	Ultraviolet activator for polymerization
Classification Name	Activator, Ultraviolet, For Polymerization
Regulation Number	872.6070
Product Code	EBZ
Legally Marketed Predicate Devices21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)Product Code
K040551	Coltolux LED Curing Light	EBZ
Device Description Summary		21 CFR 807.92(a)(4)
The proposed Coltolux Comfort LED Curing Light (Coltolux Comfort) is used for the polymerization of light-cured resin materials used indental restorations. The Coltolux Comfort incorporates a focused high-power LED to produce light in the "deep blue" spectrum(wavelength 440 - 470 nm) for activating Camphorquinone (CQ) photo-initiators. The device is utilized by placement of the lens withinclose proximity to the surface of the material to be cured, activation of the curing light via the pushbutton switch, and retention of thetip near the dental material until the composite is cured.
Intended Use/Indications for Use		21 CFR 807.92(a)(5)
The Coltolux Comfort LED Curing Light is indicated for the polymerization of intra- and extraoral dental rommaterials (commonly referred to as visible light cured dental restoratives and/or dental adhesives) that containCamphorquinone as the photoinitiator.
Indications for Use Comparison		21 CFR 807.92(a)(5)
The indications for use of the Coltolux Comfort LED Curing Light are the indications for use of the predicate device, theColtolux LED Curing Light (K040551).
Technological Comparison		21 CFR 807.92(a)(6

The Coltolux Comfort LED Curing Light (subject device) and the Coltolux LED Curing Light (predicate device) are both LED curing lights for dental composite material. The indications for use and technological characteristics are substantially equivalent with only minor

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differences, including the mechanism of battery charging and the light intensity. These minor differences do not constitute a new intended use or raise different questions of safety and effectiveness compared with the predicate device.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Performance testing was conducted to verify that the proposed Coltolux Comfort Curing Light meets the requirements as defined in FDA Guidance Document "Dental Curing Lights - Premarket Notification [510(k)" and in accordance with IEC 60601-1-2. Software verification and validation of the device were conducted in accordance with the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" Performance Testing - Bench, of this Premarket Submission, contains detailed information reqarding the proposed Coltolux Comfort Curing testing protocols, test objectives, test articles, test methods and procedures, and acceptance criteria.

Non-clinical tests performed to establish substantial equivalence to the identified predicate device included light output uniformity and dropoff testing, peak wavelength testing (ISO 10650:2018), irradiance output (ISO 10650:2018), depth of cure, endurance testing, light attenuation through barrier sleeve, light shield filtration, life testing, duty cycle (JEC 60601-1:2012), EMC (JEC 60601-1-2:2014), electromagnetic disturbances (IEC 60601-1-2:2014), and photobiological safety (IEC 62471:2006).

Not Applicable

Based on the non-clinical performance data the proposed Coltolux Comfort Curing Light is as safe, as effective, and performs as well as or better than the predicate device Coltolux LED Curing Light (K040551, 21 CRF 872.6070, product code EBZ).

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.