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Curing of all light cured bonding materials

Curing of pit and fissure sealants (unfilled resins)

Curing for all classes of composite restorations (filled resins)

Curing for endodontic composite cores

Curing composite cements for porcelain facings and inlays

Curing of light activated periodontal splint material

Curing of light activated prosthetic reline and repair material

Curing use in the fabrication of laboratory indirect light activated and provisional restorations

Teeth Whitening

BluLaze™ Blue Light Emitting Diode (LED) System

This document is an FDA 510(k) clearance letter for the BluLaze™ Blue Light Emitting Diode (LED) System. It grants marketing approval for the device but does not contain any information about acceptance criteria or a study proving the device meets those criteria.

The letter from August 20, 1999, states that the device is substantially equivalent to legally marketed predicate devices. This means that the FDA determined the new device is as safe and effective as a previously cleared device. However, it does not mandate a new clinical study or the establishment of new acceptance criteria for this specific device in this document.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on the performance characteristics or clinical study results that would typically be included in such a request.

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