(70 days)
The Optilux 501 is a visible curing unit intended for polymerization of light cure materials and activation of dental bleaching materials.
The Optilux 501 is a device used for the polymerization of dental materials using visible light. It consists of a control unit and cord connected hand piece. The molded plastic control unit contains a power inlet receptacle for a detachable mains power cord, fuse holders and fuses, mains wiring, mains supply isolation transformer, printed circuit board with control circuitry for lamp and cooling fan functions and an integrated curing radiometer. The cord connected molded plastic hand piece contains a low voltage halogen lamp, optical filter assembly and fiber optic light guide that generates visible (blue-white) light energy having the wavelength range of approximately 400nm -505 nm. The hand piece also contains a small printed circuit board with a micro-switch for activation of the curing lamp.
The provided text does not contain information about acceptance criteria or a study proving the device meets said criteria. The document is a 510(k) premarket notification for the Optilux 501 curing light, focusing on its substantial equivalence to a previously marketed device (Optilux 400).
The relevant sections describe:
- Device Name: Optilux 501 (Trade Name), Curing Light (Common Name)
- Device Description: A control unit and cord-connected hand piece used for polymerization of dental materials with visible light (400nm - 505nm). It includes a halogen lamp, optical filter, and fiber optic light guide.
- Intended Use: Polymerization of light cure materials and activation of dental bleaching materials.
- Substantial Equivalence: Claimed to be substantially equivalent to the Optilux 400, functioning similarly and having the same intended use.
- FDA's 510(k) Determination: The FDA reviewed the notification and determined the device is substantially equivalent to legally marketed predicate devices.
Therefore, I cannot populate the table or provide information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for training/test sets because this data is not present in the provided text.
The document is a regulatory approval letter based on substantial equivalence, not a performance study report with detailed acceptance criteria and validation results.
§ 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.