(38 days)
ART-L5 LED Cordless Curing Light System is used in light polymerization of dental composite and curing dental restorative thru source of illuminations.
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This document is a 510(k) clearance letter from the FDA for a dental curing light, the BONART ART-L5 LED Cordless Curing Light. It primarily addresses regulatory approval based on "substantial equivalence" to a predicate device, rather than providing details of a study with specific acceptance criteria and performance metrics for a novel AI or medical imaging device.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment is not available in the provided text.
The document confirms that:
- Device Name: BONART ART-L5 LED Cordless Curing Light System
- Indications For Use: Used in light polymerization of dental composite and curing dental restorative through a source of illuminations.
- Regulatory Class: II
- Product Code: EBZ (Ultraviolet Activator for Polymerization)
The FDA's review determined the device is substantially equivalent to legally marketed predicate devices. This means that Bonart Company, Limited did not need to conduct a new clinical trial or extensive performance study demonstrating compliance with a specific set of acceptance criteria in the same way a novel high-risk device might. Instead, they demonstrated that their device performs as safely and effectively as an already-approved device.
§ 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.