(167 days)
For light curing polymerization of dental composites, luting materials, cements and other light cured materials.
Delight, Delight ortho and B&Lite S are light-emitting diode (LED) type dental curing light that is used for polymerization of light cure resin based composites. They can be used on several different dental materials that are curable by light. The devices use LED that produce a narrow spectrum of blue light in the 430~490nm range, which is useful energy range for activating the CPQ molecule, most commonly used to initiate the photo polymerization of dental monomers. The devices are designed by considering lightweight and portability. They operate on a rechargeable battery, making it easier to carry and use.
The device is not provided sterile and is not intended to be sterilized when used. To prevent cross contamination, users must cover the device with FDA cleared barrier sheath (K132953/ TIDIShield™ Curing Light Sheath). It should be changed between each patient.
This document describes the non-clinical testing performed for the "Delight, Delight ortho, and B&Lite S" dental curing lights to demonstrate their substantial equivalence to a predicate device (Hi-Light, Hi-Light plus, K140432).
1. Table of Acceptance Criteria and Reported Device Performance
The main acceptance criteria are based on recognized standards for dental curing lights, specifically ANSI/ADA Specification No. 48 and ANSI/ADA Standard No. 48-2, as well as FDA guidance. The document highlights differences in operation modes and light intensity, and depth of cure between the subject devices and the predicate, stating that testing confirmed these differences did not raise safety and performance issues.
| Acceptance Criteria / Standard | Device Performance (Testing results according to standards) |
|---|---|
| Product Code and Regulatory Classification | Consistent with predicate (Class 2, Product Code EBZ) |
| Indications for Use | Consistent with predicate (light curing polymerization of dental composites, luting materials, cements and other light cured materials) |
| Principle of Operation | Consistent with predicate (LED type cordless dental curing light, 430-490nm blue light spectrum, activating CPQ molecule) |
| Light Source | Consistent with predicate (10W LED, 430-490nm wave range, 460nm peak wavelength) |
| Power Source | Consistent with predicate (Rechargeable Li-ion battery, AC/DC Adapter charger) |
| Chemical composition of patient contacting portions | Consistent with predicate (Disposable sheath: FDA cleared barrier sheath, K132953/TIDIShield™ Curing Light Sheath) |
| Operation Modes and Light Intensity (IEC 60601-1, ANSI/ADA specification no.42, ANSI/ADA specification no. 42-2, FDA guidance) | "The testing results show that these differences do not raise any problems in the safety and performance." Precise numerical results for each mode and device (Delight, Delight Ortho, B&Lite S) are detailed in the comparison table, showing they meet safety and performance. |
| Depth of Cure (ANSI/ADA specification no.42, ANSI/ADA specification no. 42-2, FDA guidance) | "The testing results show that these differences do not raise any problems in the safety and performance." Specific depth of cure values are correlated to operation modes, indicating successful performance. |
| Electrical Safety (IEC 60601-1:2005+A1:2012, AAMI/ANSI ES 60601-1: 2005+A1: 2012) | "The test results conformed to the standards." |
| Electromagnetic Compatibility (IEC 60601-1-2: 2007) | "The test results conformed to the standards." |
| Irradiation (Optical Power Testing) (ANSI/ADA Spec. No. 48, 48-2, FDA Guidance) | "The test results conformed to the requirements of the standards." |
| Spectral Irradiance Plot (Wavelength Spectrum Testing) (ANSI/ADA Spec. No. 48, 48-2, FDA Guidance) | "The test results conformed to the requirements of the standards." |
| Depth of Cure (Composite Hardness Testing) (ANSI/ADA Spec. No. 48, 48-2, FDA Guidance) | "The test results conformed to the requirements of the standards." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the test set. It refers to "testing results" and "performance testing - nonclinical testing" without providing specific numbers of units or measurements.
The data provenance is from non-clinical testing conducted according to international (IEC) and national (US: ANSI/ADA, FDA Guidance) standards. The country of origin of the data is not explicitly stated as it's a non-clinical test, but the applicant (DENTALL Co., Ltd.) is from Korea, suggesting the testing was likely overseen or conducted there or by a recognized testing facility acting on their behalf. The data is prospective in nature, as it was generated specifically for this premarket notification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since this is a non-clinical performance study of a device (dental curing light) assessing its physical properties and adherence to technical standards, the "ground truth" is established by adherence to predefined technical specifications and standards (e.g., optical power, wavelength, depth of cure, electrical safety). This type of study does not typically involve human experts establishing "ground truth" in the diagnostic sense (like for medical image interpretation). Instead, the "truth" is determined by calibration and measurement instruments and protocols.
4. Adjudication Method for the Test Set
Not applicable. As this is a non-clinical performance study based on objective measurements against engineering standards, an adjudication method for conflicting expert opinions is not relevant.
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
Not applicable. This is a submission for a dental curing light, which is a physical device, not an AI-based diagnostic aid. No MRMC study was performed.
6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done
The performance testing described is for the device in a standalone capacity, measuring its direct output and effect (e.g., optical power, wavelength, depth of cure). This could be considered analogous to "algorithm only" performance in that it evaluates the device's intrinsic functional specifications.
7. The Type of Ground Truth Used
The ground truth used for these non-clinical tests is based on defined technical specifications and measurement criteria outlined in relevant standards:
- IEC 60601-1 (Electrical Safety)
- IEC 60601-1-2 (Electromagnetic Compatibility)
- ANSI/ADA Specification No. 48 (Visible Light Curing Units)
- ANSI/ADA Standard No. 48-2 (LED Curing Lights)
- FDA Guidance for Industry and FDA Staff, Dental Curing Lights - Premarket Notification - 510(k) Submissions
These standards provide the benchmarks for acceptable performance and safety.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set.
§ 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.