(79 days)
Not Found
No
The summary describes a standard LED curing light for dental restorations, with no mention of AI or ML capabilities in the intended use, device description, or performance studies.
Yes
The device is used to polymerize dental restorations, which is a therapeutic action aimed at treating or improving oral health.
No
The device is used for the polymerization (curing) of dental restorative materials, which is a treatment function, not a diagnostic one.
No
The device description explicitly states it incorporates a "focused high-power LED" and is utilized by "placement of the lens within close proximity" and "activation of the curing light via the pushbutton switch," indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the polymerization of dental restorations within the mouth (intra- and extraoral). This is a therapeutic or restorative procedure performed directly on a patient.
- Device Description: The device description confirms its use in a clinical setting for curing dental materials in situ.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The device is a medical device used in a dental procedure, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
EBZ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intra- and extraoral
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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 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).
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.
Not Found
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.
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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)
Device Name
Coltolux Comfort LED Curing Light
Indications for Use (Describe)
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.
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 | Prepared on: 2022-10-03 | |||
|---|---|---|---|---|
| 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 Devices | ||||
| 21 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 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. | ||||
| 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 rom | ||||
| materials (commonly referred to as visible light cured dental restoratives and/or dental adhesives) that contain | ||||
| Camphorquinone 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, the | ||||
| Coltolux 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).