Photo Curing Light

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K852151 ↗

FDA Product Code

EBF

Device Class

Class II

Regulation

21 CFR Part 872.3690

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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• What clinical applications is this Photo Curing Light primarily used for in dentistry?

  This device is designed to initiate and accelerate the polymerization of dental resins, making it essential for hardening composite fillings, adhesives, and other light-cured materials in restorative dentistry. It emits ultraviolet light to cure these materials under controlled energy, ensuring proper setting of dental restorations.

• Is this Photo Curing Light intended for single-use or reusable in a dental office?

  The device is explicitly supplied as a reusable instrument for use in dental offices and clinical settings. While no specific sterility requirements are mentioned beyond standard dental infection control protocols, it is meant for repeated use with proper cleaning and maintenance.

• How was the regulatory clearance for this device determined, and what does that mean for its use?

  The device received FDA 510(k) clearance (K882145) under traditional review, classified as substantially equivalent to a predicate device. This means it meets established safety and performance standards for dental curing lights (product code EBZ) and is authorized for use in restorative dentistry under Class II – Special Controls.

• What should clinicians consider when storing or maintaining this reusable Photo Curing Light?

  While the data does not specify storage conditions, standard dental protocols for reusable instruments should apply—such as cleaning, disinfection, and proper storage to prevent contamination. Since it operates via ultraviolet light, ensure the device is free from obstructions or damage that could affect its curing performance.