(15 days)
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.
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.